[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Takeda\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":577},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,97,0,25,[9,47,73,96,120,144,166,188,212,238,256,289,310,331,351,376,397,419,439,460,479,496,516,538,557],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100642659","phase-2-a-study-of-tak-360-in-people-with-narcolepsy-or-idiopathic-hypersomnia-100642659",false,"NCT07646678","A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia","A Long-term Extension Trial to Evaluate the Safety and Tolerability of TAK-360 in Participants With Selected Central Hypersomnia Conditions","Key Inclusion Criteria:\n\n1. Participant is willing and able to understand and fully comply with trial procedures and requirements.\n2. Participant has a confirmed diagnosis of either NT1, NT2, or IH, and has completed the treatment period of a parent TAK-360 trial.\n3. Participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form (ICF) and any required privacy authorization before the initiation of any trial procedures.\n\nKey Exclusion Criteria:\n\n1. Participant has a positive pregnancy test or is lactating\u002Fbreastfeeding.\n2. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).\n3. The participant has developed a new medical disorder associated with excessive daytime sleep (EDS).\n4. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.\n5. Participant has developed a new history of seizures.\n6. Participant has experienced clinically significant head injury, per investigator opinion.\n7. Participant has developed a history of cerebral ischemia, transient ischemic attack (less than \\[\\\u003C\\] 5 years ago), or cerebral haemorrhage.\n8. Participant has developed a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.\n9. The participant has been diagnosed with medically significant thyroid disease, known functional hepatic impairment, or other severe chronic medical condition other than the central hypersomnolence disorder.\n10. Participant has developed a history of cancer in the past 5 years.","ALL","18 Years","71 Years",{"count":21,"type":22},500,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","Central hypersomnia conditions are a group of sleeping disorders where the brain has trouble keeping a person awake during the day (called excessive daytime sleepiness or EDS). These conditions usually include narcolepsy (type 1 and 2) and idiopathic hypersomnia (IH). Narcolepsy type 1 (NT1) includes sudden muscle weakness while you stay awake, called cataplexy, often triggered by strong emotions. Narcolepsy type 2 (NT2) does not include cataplexy. People with narcolepsy typically feel refreshed by short naps. People with IH feel extremely sleepy during the day, and do not feel refreshed by sleep. Waking up from sleep is difficult. This is common in the morning and also when waking up from long naps.\n\nThe study wants to learn about TAK-360 when taken over a long time period; this is called a long-term extension or LTE study. The main aim of this LTE study is to find out how well participants with NT1, NT2, and IH tolerate TAK-360 over a longer period (long-term tolerability) and to learn how safe TAK-360 is when given over a longer period of time (long-term safety).\n\nParticipants who completed one of the TAK-360 parent studies can join this study if they meet the study rules. Parent studies include TAK-360-2001(NCT06952699), TAK-360-2002 (NCT06812078), or other TAK-360 studies that evaluate the TAK-360 medicine. All participants will receive TAK-360 in this study. They will either receive the same dose as they did in the parent study, or the closest dose available in this LTE study. Participants who received placebo (the placebo looks just like TAK-360 but does not have any medicine in it) in their parent study will receive one of the TAK-360 doses available in this study. Placebo will only be used to not reveal the dose of TAK-360 from parent studies to investigator, participants, and sponsor. Sponsor, investigators and participants will not know which TAK-360 dose was used in the LTE study as long as the parent study is ongoing.\n\nThe participants will have to visit the clinic multiple times during this study.",[29,30,31],"Idiopathic Hypersomnia","Narcolepsy Type 1","Narcolepsy Type 2",[33],"Drug Therapy","RECRUITING","2026-08-20",{"date":37,"type":38},"2026-08-21","ACTUAL",{"date":40,"type":38},"2026-06-11",{"date":42,"type":22},"2031-06-15",{"name":44,"class":45},"Takeda","INDUSTRY",13,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100554453","phase-3-a-study-of-elritercept-to-treat-anemia-in-adults-with-very-low-low-or-intermediate-risk-myelodysplastic-syndromes-mds-who-need-regular-blood-transfusions-100554453","NCT06499285","A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants With Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)","Inclusion Criteria:\n\n* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information and\u002For protected personal data in accordance with national and local study participant data protections and privacy regulations.\n* Male or female greater than or equal to (≥)18 years of age at the time of signing informed consent.\n* Diagnosis of MDS with or without RS (as determined in an evaluable bone marrow aspirate, read by an independent central reader to confirm diagnosis at Screening) according to the World Health Organization 2016 classification that meets the International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease.\n* Transfusion dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either:\n\n  a. Low-transfusion burden (LTB), defined as 4 to 7 red blood cells (RBC) units per 16 weeks; or b. High-transfusion burden (HTB), defined as ≥8 RBC units per 16 weeks; and c. For all participants: i. Only transfusion events for a pretransfusion hemoglobin (Hgb) lesser than (\\\u003C)10 grams per deciliter (g\u002FdL) are counted toward eligibility; ii. At least 1 transfusion event in each 8-week period and a minimum of 2 transfusion events separated by ≥7 days within the 16-week period immediately preceding randomization; and iii. No consecutive 56-day period can be RBC transfusion-free during the 16-week period immediately preceding randomization.\n* Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued ≥4 weeks before randomization), or unlikely to respond to ESA treatment, defined as follows:\n\n  a. Refractory to prior ESA treatment: documentation of nonresponse or a response that was no longer maintained with a prior ESA-containing regimen, either as a single agent or combination (e.g., with granulocyte colony-stimulating factor \\[G-CSF\\]); ESA regimen must have been either: i. Recombinant human erythropoietin (EPO) ≥40,000 international units per week (IU\u002Fweek) for ≥8 doses or equivalent; or ii. Darbepoetin alpha ≥500 micrograms (μg) every 3 weeks for ≥4 doses or equivalent.\n\n  b. Intolerant to prior ESA treatment: documentation of discontinuation of a prior ESA-containing regimen, either as a single agent or combination (e.g., with G-CSF), at any time after introduction due to intolerance or an AE.\n\n  c. Unlikely to respond to ESA treatment: low chance of response to ESA based on an endogenous serum EPO level greater than (\\>)200 units per liter (U\u002FL).\n* Less than 5% blasts in an evaluable bone marrow aspirate collected at Screening, read by an independent central reader.\n* Eastern Cooperative Oncology Group performance status of 0 to 2.\n* Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception.\n* In the opinion of the Investigator, the participant is able and willing to comply with the requirements of the protocol (e.g., all study procedures, return for follow-up visits).\n\nExclusion Criteria:\n\n* Del(5q) MDS or therapy-related (secondary) MDS.\n* Anemia due to any other known cause (e.g., thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and\u002For folate).\n* Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks before randomization.\n* Clinically significant cardiovascular disease defined as:\n\n  1. New York Heart Association heart disease class III or IV;\n  2. Fridericia corrected QT (QTcF) interval \\>500 milliseconds during Screening;\n  3. Presence of uncontrolled hypertension defined as mean systolic blood pressure ≥160 millimeters of mercury (mm Hg) or diastolic blood pressure ≥100 mm Hg during Screening; or\n  4. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before Screening.\n* Known ejection fraction \\\u003C35%, confirmed by a local echocardiogram performed during Screening, or a previously performed echocardiogram if collected within 6 months before Screening.\n* Child-Pugh class C hepatic impairment.\n* Stroke, deep vein thrombosis, or pulmonary embolism within 6 months before Screening.\n* Any known history of acute myeloid leukemia (AML).\n* Prior history of malignancies, other than MDS, unless participant has been free of the disease (including completion of any treatment, including maintenance, for prior malignancy) for ≥ 5 years. However, participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:\n\n  1. Basal or squamous cell carcinoma of the skin;\n  2. Carcinoma in situ of the cervix;\n  3. Carcinoma in situ of the breast; and\u002For\n  4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis \\[TNM\\] clinical staging system).\n* History of solid organ or bone marrow transplantation.\n* Active infection requiring intravenous treatment (e.g., antibiotics, antifungals, or antivirals) within 28 days, or oral treatment within 14 days before randomization.\n* History of or known active chronic infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV). Participants without known positive history of HIV, HBV, and\u002For HCV do not require further testing, unless testing is mandated per local guidelines.\n* Body mass index ≥ 40 kilograms per meter square (kg\u002Fm\\^2).\n* Major surgery within 28 days before randomization.\n* History of allergy\u002Fanaphylaxis to investigational medicinal product (IMP) excipients (refer to the current elritercept IB for a list of excipients) or recombinant proteins.\n* Prior use of elritercept, luspatercept, or sotatercept.\n* Prior use of hypomethylating agents (HMAs), isocitrate dehydrogenase inhibitor, lenalidomide, imetelstat, or immunosuppressive therapy given for treatment of MDS.\n* Iron chelation therapy initiated within 8 weeks before randomization. Participants on stable doses of iron chelation therapy for ≥ 8 weeks are allowed.\n* Vitamin B12 or folate therapy initiated within 4 weeks before randomization. Participants on stable replacement doses for ≥ 4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.\n* Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥ 8 weeks are allowed.\n* High-dose corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone lesser than or equal to (≤) 10 mg\u002Fday or corticosteroid equivalent for ≥ 4 weeks are allowed.10 mg\u002Fday or corticosteroid equivalent for ≥ 4 weeks are allowed.\n* Treatment with any investigational drug within 28 days before Screening or, if the half-life of the product is known, within 5 times the half-life before Screening, whichever is longer.\n* Ongoing participation in another interventional clinical study.\n* Serum EPO level \\>500 U\u002FL.\n* Platelet count ≥450 × 10\\^9\u002FL or ≤25 × 10\\^9\u002FL.\n* Absolute neutrophil count ≤ 500\u002FµL.\n* Serum aspartate aminotransferase or alanine aminotransferase ≥3 × the upper limit of normal (ULN).\n* Total bilirubin ≥2 × ULN unless attributable to Gilbert's syndrome.\n* Ferritin ≤ 50 micrograms per litre (μg\u002FL).\n* Folate ≤2.0 nanograms per milliliter (ng\u002FmL).\n* Vitamin B12 ≤200 picograms per milliliter (pg\u002FmL).\n* Estimated glomerular filtration rate \\\u003C30 milliliters per minute per 1.73 meter square (mL\u002Fmin\u002F1.73m\\^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Collaboration equation.\n* Pregnant or lactating female.\n* Any other condition not specifically noted above that, in the opinion of the Investigator, would preclude the participant from participating in the study or could confound interpretation of data from the study.\n* Investigational site staff members directly involved in the conduct of the study and site staff members otherwise supervised by the Investigator, employees of the Sponsor or contract research organization (CRO) directly involved in the conduct of the study, or immediate family members (defined as a spouse, parent, child, or sibling, whether biological or legally adopted).\n* For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults (per applicable French law \\[Art. L. 1121-6, Art. L. 1121-8, Art. L. 1121-8-1\\]).",{"count":55,"type":22},225,[26],"The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs. The study will also check on how safe elritercept is and how well it is tolerated.",[59],"Myelodysplastic Syndromes",[61,62,63,64,65],"Anemia","Elritercept","Myelodysplastic neoplasms","KER-050","MDS",{"date":37,"type":38},{"date":68,"type":38},"2025-05-06",{"date":70,"type":22},"2032-05-01",{"name":44,"class":45},177,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100394713","phase-2-a-study-of-elritercept-to-treat-anemia-in-adults-with-very-low-low-or-intermediate-risk-myelodysplastic-syndromes-mds-100394713","NCT04419649","A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)","A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)","Inclusion Criteria:\n\n1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local study participant privacy regulations.\n2. Male or female ≥ 18 years of age, at the time of signing informed consent.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia).\n4. Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception.\n5. In the opinion of the Investigator, the participant is able and willing to comply with the requirements of the protocol (e.g., all study procedures, return for follow-up visits).\n\nPart 1 Inclusion Criteria\n\nParticipants are eligible to be included in Part 1 of the study only if all the following criteria apply:\n\n1. Diagnosis of MDS according to WHO classification that meets International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease.\n2. Less than (\\\u003C)5percent (%) blasts in bone marrow during the Pretreatment Period.\n3. Peripheral blood white blood cell (WBC) count \\\u003C13,000\u002Fmicroliter (μL) during the Pretreatment Period.\n4. Anemia defined as:\n\n   1. In non-transfused participants, having received no RBC transfusions within 8 weeks, Hgb concentration ≤ 10.0 g\u002FdL during the Pretreatment Period OR\n   2. In LTB participants, having received 1 to 3 units of RBCs for Hgb ≤ 9.0 g\u002FdL within 8 weeks of the Pretreatment Period.\n\n      OR\n   3. In HTB participants, having received ≥ 4 units of RBCs for Hgb ≤ 9.0 g\u002FdL within 8 weeks of the Pretreatment Period.\n\nPart 1 Extension - Abbreviated Inclusion Criteria\n\nParticipants from Part 1 are eligible to be included in Part 1 Extension of the study only if all the following criteria apply:\n\n1. Previously completed 4 cycles of elritercept in Part 1 with no dose-limiting toxicities (DLTs).\n2. Participant has the potential to benefit from administration of elritercept, in the opinion of the Investigator.\n3. \\\u003C 5% blasts in bone marrow.\n4. Peripheral WBC count \\\u003C 13,000\u002FμL during the 28 days prior to cycle 5 day 1 (C5D1).\n\nPart 2 Inclusion Criteria\n\nParticipants are eligible to be included in Part 2 of the study only if all the following criteria apply:\n\n1. Cohort A:\n\n   * Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.\n   * ring sideroblast (RS)-positive as defined by WHO 2016 criteria.\n   * Requiring at least 2 units of RBC transfusions in the preceding 8 weeks before cycle 1 day 1 (C1D1).\n2. Cohort B:\n\n   * Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.\n   * Non-RS as defined by WHO 2016 criteria.\n   * Requiring at least 2 units of RBC transfusions in the 8 weeks before C1D1.\n3. Cohort C:\n\n   * Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.\n   * Has anemia, defined by Hgb ≤ 10 g\u002FdL during the Pretreatment Period, and received no RBC transfusion in the 8 weeks before C1D1.\n4. Cohort D:\n\n   * Diagnosis of CMML according to WHO classification.\n   * Has anemia, defined by Hgb ≤ 10 g\u002FdL during the Pretreatment Period, and received no RBC transfusion in the 8 weeks before C1D1.\n   * OR\n   * Received at least 2 units of RBC transfusions for anemia in the 8 weeks before C1D1.\n5. Cohort E:\n\n   * Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.\n   * Requiring ≥ 2 units of RBC transfusions in the preceding 8 weeks before C1D1.\n   * Receipt of ≥ 20 units of RBC in transfusion over the participant's lifetime.\n   * Serum ferritin \\> 1000 nanograms per milliliter (ng\u002FmL) on ≥ 2 assessments in the preceding 8 weeks before C1D1.\n   * Treated with stable dose of iron chelation therapy for ≥ 8 weeks prior to C1D1.\n6. Cohort F:\n\n   * Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.\n   * Requiring ≥ 2 units of RBC transfusions in the preceding 8 weeks before C1D1.\n   * Receipt of ≥ 20 units of RBC in transfusion over the participant's lifetime.\n   * Serum ferritin \\> 1000 ng\u002FmL on ≥ 2 assessments in the preceding 8 weeks before C1D1.\n   * Not treated with iron chelation therapy in the preceding 8 weeks before C1D1 and not eligible to initiate iron chelation therapy in the opinion of the Investigator and in accordance with local treatment guidelines for initiation of iron chelation therapy.\n7. Cohort G:\n\n   * Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.\n   * RS-positive as defined by WHO 2016 criteria OR non-RS as defined by WHO 2016 criteria.\n   * Relapsed, refractory, or intolerant to frontline luspatercept treatment and have not received an interceding therapy (for example, erythropoiesis-stimulating agent \\[ESA\\])\n\n     * Relapsed is defined as documentation of response to luspatercept therapy and subsequent development of a need for transfusion(s).\n     * Refractory is defined as documentation of no response with luspatercept ≥ 1 mg\u002Fkg administered for ≥ 12 weeks duration.\n     * Intolerant is defined as documentation of discontinuation of luspatercept therapy due to intolerance or an AE at any time after introduction.\n   * Requiring ≥ 2 units of RBC transfusions over 8 weeks prior to C1D1.\n   * Erythropoietin (EPO) \\\u003C 500 international units per liter (U\u002FL) at Baseline.\n   * Last dose of luspatercept is ≥ 3 weeks and \\\u003C 12 months from C1D1.\n8. \\\u003C 5% blasts in bone marrow assessed by bone marrow aspirate during the Pretreatment Period.\n\nPart 1 Exclusion Criteria\n\nParticipants are excluded from Part 1 of the study if any of the following criteria apply.\n\nMedical History\n\n1. Diagnosis of MDS with deletion of chromosome 5q (Del5q).\n2. Active infection requiring parenteral antibiotic therapy within 28 days prior to C1D1 or oral antibiotics within 14 days of C1D1. Prophylactic antibiotics and\u002For antifungals for neutropenia are allowed.\n3. Presence of uncontrolled heart disease or New York Heart Association (NYHA) Class III or IV heart failure.\n4. History of drug or alcohol abuse (as defined by the Investigator) within the past 2 years.\n5. History of stroke, deep venous thrombosis (DVT), or arterial embolism within 6 months prior to C1D1.\n6. Major surgery within 28 days prior to C1D1. Participants must be completely recovered from any previous surgery prior to C1D1.\n7. Known positive for human immunodeficiency virus (HIV), active infectious hepatitis B virus (HBV), or active infectious hepatitis C virus (HCV). Participants without known positive history of HIV, HBV, and\u002For HCV do not require further testing, unless testing is mandated per local guidelines.\n8. Any malignancy other than MDS that has not been in remission and\u002For has required systemic therapy including radiation, chemotherapy, hormonal therapy, or surgery, within 1 year prior to C1D1. Diagnosis of secondary MDS (i.e., MDS known to have arisen as the result of chemical injury or treatment with chemotherapy and\u002For radiation for other diseases).\n9. History of solid organ or hematological transplantation.\n10. Presence of uncontrolled hypertension, defined as systolic blood pressure (BP) ≥ 150 mmHg or diastolic BP ≥ 100 mmHg despite adequate treatment.\n11. Body mass index (BMI) ≥ 40 kilograms per meter square (kg\u002Fm\\^2) during the Pretreatment Period.\n12. History of severe allergic or anaphylactic reaction(s) or hypersensitivity to recombinant proteins or excipients in the investigational medicinal product (IMP).\n\nTreatment History\n\n1. Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.\n2. Treatment with ESA within 56 days prior to C1D1.\n3. Prior or concurrent chronic treatment with granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF).\n4. Iron chelation therapy if initiated within 8 weeks prior to C1D1.\n5. Vitamin B12 therapy initiated within 8 weeks prior to C1D1. Participants on stable replacement doses for ≥ 8 weeks and without concurrent vitamin B12 or folate deficiency are allowed.\n6. Treatment with another investigational drug or device or approved therapy for investigational use ≤ 28 days prior to C1D1, or, if the half-life of the previous product is known, within 5 times the half-life prior to C1D1, whichever is longer.\n\nLaboratory Exclusions (during Pretreatment Period)\n\n1. Platelet count \\> 450 ✕ 10\\^9\u002FL or \\\u003C 30 ✕ 10\\^9\u002FL.\n2. Transferrin saturation \\\u003C 15%.\n3. Ferritin \\\u003C 50 nanograms per milliliter (ng\u002FmL).\n4. Folate \\\u003C 4.5 nanomoles per liter (nmol\u002FL) (\\\u003C 2.0 ng\u002FmL).\n5. Vitamin B12 \\\u003C 148 picomoles per liter (pmol\u002FL) (\\\u003C 200 picograms per milliliter \\[pg\u002FmL\\]).\n6. Estimated glomerular filtration rate (GFR) \\\u003C 30 milliliter per minute per 1.73 meter square (mL\u002Fmin\u002F1.73 m\\^2), as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.\n7. Positive for HIV.\n\nMiscellaneous\n\n1. Pregnant or lactating females.\n2. Any other condition not specifically noted above which, in the opinion of the Investigator, would preclude the participant from participating in the study.\n3. Participants who are investigational site staff members directly involved in the conduct of the trial and their immediate family members, site staff members otherwise supervised by the Investigator, or participants who are Sponsor or contract research organization (CRO) employees directly involved in the conduct of the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.\n\nPart 1 Extension - Exclusion Criteria\n\nParticipants from Part 1 are excluded from Part 1 Extension of the study if any of the following criteria apply.\n\nMedical History\n\n1. Discontinuation of IMP in Part 1 for any reason.\n2. Has not completed a study visit in the past 12 months.\n3. Active infection requiring parenteral antibiotic therapy within 28 days prior to C5D1 or oral antibiotics within 14 days of C5D1. Prophylactic antibiotics and\u002For antifungals for neutropenia are allowed.\n4. Presence of uncontrolled heart disease or NYHA Class III or IV heart failure.\n5. History of drug or alcohol abuse (as defined by the Investigator) within the past 2 years.\n6. History of stroke, DVT, or arterial embolism within 6 months prior to C5D1.\n7. Major surgery within 28 days prior to C5D1. Participants must be completely recovered from any previous surgery prior to C5D1.\n8. Known positive for HIV, active infectious HBV, or active infectious HCV. Participants without known positive history of HIV, HBV, and\u002For HCV do not require further testing, unless testing is mandated per local guidelines.\n9. Any malignancy other than MDS that has not been in remission and\u002For has required systemic therapy including radiation, chemotherapy, hormonal therapy, or surgery, within 1 year prior to C5D1.\n10. History of solid organ or hematological transplantation.\n11. Presence of uncontrolled hypertension, defined as systolic BP ≥ 150 mmHg or diastolic BP ≥ 100 mmHg despite adequate treatment.\n12. BMI ≥ 40 kg\u002Fm\\^2 during the 28 days prior to C5D1.\n\nTreatment History\n\n1. Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.\n2. Treatment with ESA within 56 days prior to C5D1.\n3. Prior or concurrent chronic treatment with G-CSF or GM-CSF.\n4. Iron chelation therapy if initiated within 8 weeks prior to C5D1.\n5. Vitamin B12 with treatment initiated within 8 weeks prior to C5D1. Participants on stable replacement doses for ≥ 8 weeks and without concurrent vitamin B12 or folate deficiency are allowed.\n6. Treatment with another investigational drug or device or approved therapy for investigational use ≤ 28 days prior to C5D1, or, if the half-life of the previous product is known, within 5 times the half-life prior to C5D1, whichever is longer. Previous treatment with elritercept is acceptable.\n\nLaboratory Exclusions (during Abbreviated Pretreatment Period)\n\n1. Platelet count \\> 450 × 10\\^9\u002FL or \\\u003C 30 × 10\\^9\u002FL.\n2. Transferrin saturation \\\u003C 15%.\n3. Ferritin \\\u003C 50 ng\u002FmL.\n4. Folate \\\u003C 4.5 nmol\u002FL (\\\u003C 2.0 ng\u002FmL).\n5. Vitamin B12 \\\u003C 148 pmol\u002FL (\\\u003C 200 pg\u002FmL).\n6. Estimated GFR \\\u003C 30 mL\u002Fmin\u002F1.73 m\\^2, as determined by the CKD-EPI equation.\n\nMiscellaneous\n\n1. Pregnant or lactating females.\n2. Any other condition not specifically noted above which, in the opinion of the Investigator, would preclude the participant from participating in the study.\n3. Participants who are investigational site staff members directly involved in the conduct of the trial and their immediate family members, site staff members otherwise supervised by the Investigator, or participants who are Sponsor or CRO employees directly involved in the conduct of the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.\n\nPart 2 Exclusion Criteria\n\nParticipants are excluded from Part 2 of the study if any of the following criteria apply.\n\nMedical History\n\n1. Diagnosis of MDS with Del5q.\n2. Diagnosis of secondary MDS (i.e., MDS known to have arisen as the result of chemical injury or treatment with chemotherapy and\u002For radiation for other diseases).\n3. Active infection requiring parenteral antibiotic therapy within 28 days prior to C1D1 or oral antibiotics within 14 days of C1D1. Prophylactic antibiotics and\u002For antifungals for neutropenia are allowed.\n4. Presence of the following cardiac conditions:\n\n   1. Presence of uncontrolled heart disease or NYHA Class III or IV heart failure.\n   2. QTcF (QT interval corrected by Fridericia's formula) \\> 500 msec on the screening or C1D1 electrocardiogram (ECG; mean of 3 measurements).\n   3. Uncontrolled clinically significant arrhythmia (participants with rate-controlled atrial fibrillation are not excluded).\n   4. Acute myocardial infarction or unstable angina pectoris ≤ 6 months prior to C1D1.\n5. Presence of uncontrolled hypertension, defined as systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite adequate treatment.\n6. History of stroke, DVT, or arterial embolism within 6 months prior to C1D1.\n7. History of drug or alcohol abuse (as defined by the Investigator) within the past 2 years.\n8. Major surgery within 28 days prior to C1D1. Participants must be completely recovered from any previous surgery prior to C1D1.\n9. Any malignancy other than MDS or CMML that has not been in remission and\u002For has required major surgery or systemic therapy including radiation, chemotherapy, targeted therapy, or hormonal therapy within 1 year prior to C1D1.\n10. History of solid organ or hematological transplantation.\n11. Diagnosis of hemolytic anemia, active bleeding, hemoglobinopathies, or congenital disorders as a cause of the participant's anemia.\n12. NCI-CTCAE Grade ≥ 2 bleeding events within the 3 months prior to C1D1.\n13. Receipt of an RBC or platelet transfusion for any reason(s) or combination of reasons other than underlying MDS within the 16 weeks prior to C1D1. If a participant requires a transfusion for an unanticipated reason during the Pretreatment Period, a prolonged screening period may be considered after discussion with the Medical Monitor.\n14. Known positive for HIV, active infectious HBV with positive viral load (HBV DNA), or active infectious HCV with positive viral load (HCV RNA). Participants without known positive history of HIV, HBV, and\u002For HCV do not require further testing, unless testing is mandated per local guidelines.\n15. BMI ≥ 40 kg\u002Fm\\^2.\n16. History of severe allergic or anaphylactic reaction(s) or hypersensitivity to recombinant proteins or excipients in the IMP.\n17. Diagnosis of cirrhosis, non-alcoholic steatohepatitis, alcoholic liver disease, hepatitis, or other liver disease (acute or chronic) meeting Child-Pugh C criteria for hepatic impairment. Participants with elevated liver enzymes are allowed if the liver enzyme elevation is suspected to be due to iron-overload or iron chelation, and other hepatic causes have been ruled out, in the opinion of the Investigator.\n\nTreatment History\n\n1. Prior treatment with azacitidine, decitabine, lenalidomide, or sotatercept.\n2. Prior treatment with luspatercept (Cohorts A, B, C, D, E, and F only).\n3. Treatment with ESA within 8 weeks prior to C1D1.\n4. Prior or concurrent chronic treatment with G-CSF or GM-CSF, for reasons other than for treatment of MDS.\n\n   a. Note: Previous treatment with G-CSF or GM-CSF for MDS, which has been discontinued ≥ 8 weeks prior to C1D1 is allowed.\n5. Iron chelation therapy if initiated within 8 weeks prior to C1D1. Participants on stable doses of iron chelation therapy for ≥ 8 weeks are allowed.\n6. Vitamin B12 and\u002For folate therapy initiated within 8 weeks prior to C1D1. Participants on stable replacement doses for ≥ 8 weeks and without concurrent vitamin B12 or folate deficiency are allowed.\n7. Any need to receive a prohibited medication.\n8. Treatment with another investigational drug or device or approved therapy for investigational use within 8 weeks prior to C1D1, or, if the half-life of the previous product is known, within 5 times the half-life prior to C1D1, whichever is longer.\n\nLaboratory Exclusions (during Pretreatment Period)\n\n1. Peripheral WBC count ≥ 13,000\u002FμL.\n2. Platelet count \\> 450 × 10\\^9\u002FL or \\\u003C 25 × 10\\^9\u002FL.\n3. Transferrin saturation \\\u003C 15%.\n4. Ferritin \\\u003C 50 ng\u002FmL.\n5. Folate \\\u003C 4.5 nmol\u002FL (\\\u003C 2.0 ng\u002FmL).\n6. Vitamin B12 \\\u003C 148 pmol\u002FL (\\\u003C 200 pg\u002FmL).\n7. Estimated GFR \\\u003C 30 mL\u002Fmin\u002F1.73 m\\^2 as determined by the CKD-EPI equation.\n\nMiscellaneous\n\n1. Pregnant or lactating females.\n2. Any other condition not specifically noted above which, in the opinion of the Investigator, would preclude the participant from participating in the study.\n3. Participants who are investigational site staff members directly involved in the conduct of the trial and their immediate family members, site staff members otherwise supervised by the Investigator, or participants who are Sponsor or CRO employees directly involved in the conduct of the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.\n\nFor Cohort G ONLY:\n\n1. Any luspatercept related AE Grade ≥ 3 that has not resolved to baseline or Grade ≤ 1.\n2. No history of allergy\u002Fanaphylaxis\u002Fhypersensitivity to luspatercept.\n3. No prior treatment with imetelstat.",{"count":81,"type":22},160,[25],"The main aim of this study is to learn how safe elritercept is and how well adults with anemia associated with lower-risk MDS tolerate treatment with different doses of elritercept. Other aims are to learn how safe elritercept is by looking at how many participants have MDS that worsens during the study and learn about the effects of elritercept on anemia linked to MDS. The study will also look to learn how elritercept affects the production of healthy RBCs.",[59,85],"Cytopenia",[87,33,62,88,64],"Transfusion","TAK-226",{"date":37,"type":38},{"date":91,"type":38},"2020-08-19",{"date":93,"type":22},"2031-10-30",{"name":44,"class":45},53,{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":106,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100589306","phase-2-a-study-of-tak-360-in-adults-with-narcolepsy-without-cataplexy-nt2-100589306","NCT06952699","A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)","A Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding, Adaptive Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Narcolepsy Without Cataplexy (NT2)","Key Inclusion Criteria:\n\n1. The participant weighs greater than equal or to (≥)40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg\u002Fm\\^2) \\[inclusive\\].\n2. The participant has a documented, current diagnosis of NT2.\n\nKey Exclusion Criteria:\n\n1. The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2.\n2. The participant has medically significant thyroid disease.\n3. The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ \\[such as basal cell carcinoma\\] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor).\n4. The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus (HCV) antibody (at screening), human immunodeficiency virus (HIV) antibody\u002Fantigen (at screening).\n5. The participant has a clinically significant history of head injury or head trauma.\n6. The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).\n7. The participant has a history of cerebral ischemia, transient ischemic attack (\\\u003C5 years from screening), intracranial aneurysm, or arteriovenous malformation.","70 Years",{"count":105,"type":22},88,[25],"Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. They may have difficulty thinking clearly, paying attention, or remembering things, during the day. These symptoms can make daily activities like driving, working, or caring for their families challenging, impacting their quality of life. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake.\n\nThe main aim of this study is to learn how safe TAK-360 is and how well adults with NT2 tolerate it. Researchers also want to find out if TAK-360 can help people with NT2 stay awake and determine the right dosage needed to do that.\n\nParticipants will be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo in the treatment period. The placebo is a pill that looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.",[31],[110,111,112],"Narcolepsy without Cataplexy","NT2","TAK-360","2026-08-19",{"date":35,"type":38},{"date":68,"type":38},{"date":117,"type":22},"2026-11-30",{"name":44,"class":45},52,{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":23,"phases":129,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},"100623116","phase-2-a-study-of-tak-755-in-adults-with-acute-ischemic-stroke-100623116","NCT07392450","A Study of TAK-755 in Adults With Acute Ischemic Stroke","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-755 in Acute Ischemic Stroke","Inclusion Criteria:\n\nInformed Consent:\n\n1. The participant or legally authorized representative has provided informed consent or deferred consent eligibility confirmed before the initiation of any trial procedures.\n\n   Age:\n2. greater than and equal to (\\>=) 18 years of age, inclusive, at the time of signing the Informed Consent Form (ICF) or confirmation of deferred consent eligibility.\n\n   Clinical Characteristics:\n3. Clinical diagnosis of AIS.\n4. Onset of stroke symptoms within 24 hours of randomization. Wake-up strokes may be included if Last Known Well is within 24 hours of randomization; time of onset will be considered the time of Last Known Well.\n5. National Institutes of Health Stroke Scale score of 5 to 25, indicating moderate to severe stroke. Participants with an NIHSS score of 5 are eligible only if at least 1 predefined disabling neurological deficit is present, as defined by one or more of the following\n\n   NIHSS criteria:\n   * Complete hemianopia (NIHSS visual score \\>=2).\n   * Aphasia impairing meaningful communication (NIHSS language score \\>=2).\n   * Motor deficit with inability to sustain effort against gravity (NIHSS left or right motor arm or leg score \\>=2).\n6. Estimated Modified Rankin Scale score less than (\\\u003C) 2 prior to AIS presentation, signifying no significant disability.\n7. Persistent neurological signs and symptoms consistent with unilateral supratentorial circulation stroke.\n\n   Imaging:\n8. Evidence of causative AIS occlusions affecting supratentorial circulation on imaging (intracranial internal carotid artery \\[ICA\\], middle cerebral artery \\[MCA; M1 - M4\\], anterior cerebral artery \\[ACA; A1 - A3\\], posterior cerebral artery \\[PCA; P1 - P3\\]).\n9. Evidence of salvageable brain tissue on CT or MR imaging.\n\nExclusion Criteria:\n\nMedical History:\n\n1. Weight \\>130 kilograms (kg) or \\\u003C40 kg.\n2. History of severe traumatic brain injury in the past 90 days.\n3. History of intracranial hemorrhage.\n4. History of intracranial neoplasm except for small meningioma.\n5. History of prior stroke in the past 90 days.\n6. History of intracranial or intraspinal surgery within the past 90 days.\n7. Major surgery or severe trauma in the past 14 days.\n8. History of cerebral amyloid angiopathy.\n9. Recent history of active systemic malignancy within the last 5 years, except for locally excised basal cell or squamous cell skin carcinoma with clear margins.\n10. Diagnosis of serious, advanced, or terminal illness with anticipated life expectancy of less than 1 year.\n11. Participation in other interventional clinical trials within the previous 90 days.\n12. Known life-threatening hypersensitivity reaction to TAK-755 or its components.\n13. Any prior administration of TAK-755.\n14. Administration of caplacizumab in the past 30 days.\n15. Administration of von Willebrand factor-containing products in the past 14 days.\n16. Baseline conditions (prior to the index AIS event) that prevent an understanding of the nature, scope, and possible consequences of the trial, in the judgment of the investigator.\n\n    Current Stroke Management:\n17. Any prior administration (intravenous or intra-arterial) of alteplase or tenecteplase for the index AIS event, as well as any prior administration of prourokinase or reteplase for the index AIS event in countries where approved.\n18. Eligible for administration of intravenous thrombolysis (alteplase or tenecteplase, as well as prourokinase or reteplase in countries where approved) for the index AIS event, based on the site's standard clinical guidelines and direct availability.\n19. Intent to proceed with endovascular thrombectomy (EVT) for the index AIS event based on eligibility and direct availability.\n20. Seizure at time of index AIS event onset, only if it precludes accurate assessment of baseline NIHSS.\n21. Persistent blood pressure elevation (systolic \\>=185 millimeters of mercury \\[mmHg\\] or diastolic \\>=110 mm Hg) prior to randomization.\n22. Blood glucose \\\u003C50 milligrams per deciliter (mg\u002FdL) or \\>400 mg\u002FdL.\n\n    Current Medical Conditions:\n23. Active, uncontrolled bleeding.\n24. Bleeding diathesis or any other conditions that would pose significant bleeding risk.\n25. Inability to undergo MRI or CT.\n26. Chronic causative intracranial occlusion.\n27. Causative total occlusion of the extracranial ICA.\n28. Evidence of septic emboli or bacterial endocarditis.\n29. Another clinically significant concomitant disease that may pose additional risks for the participant in the opinion of the investigator.\n30. Pregnancy, lactation, or unable to comply with birth control methods or abstinence as specified in the protocol in the opinion of the investigator.\n\n    Imaging:\n31. Poor quality imaging that precludes interpretation according to trial protocol.\n32. Evidence of significant intracranial mass effect or midline shift.\n33. Evidence of acute occlusion in \\>1 vascular territory (right\u002Fleft MCA, right\u002Fleft ACA, right\u002Fleft PCA); multiple occlusions within the same vascular territory are allowed.\n34. Evidence of acute or chronic intracranial hemorrhage (presence of chronic cerebral microbleeds on magnetic resonance imaging \\[MRI\\]) T2\\*-weighted type sequence (such as gradient recalled echo \\[GRE\\] or susceptibility weighted imaging \\[SWI\\]) is not exclusionary if total \\\u003C10 and not consistent with diagnosis of cerebral amyloid angiopathy).\n35. Evidence of extensive early ischemic change estimated to be greater than one-third of the middle cerebral artery territory or evidence of well-demarcated hypoattenuation on computed tomography (CT), if performed, consistent with established infarction and judged by the investigator to correspond to the clinical symptoms of the index AIS.\n36. Evidence of intracranial tumor (except incidental, small meningioma), cerebral aneurysm, or arteriovenous malformation.\n\n    Laboratory:\n37. Platelet count \\\u003C50,000\u002F cubic millimeters (mm\\^3).\n\n    Other:\n38. Identification by the investigator as being potentially unable or unwilling to cooperate with trial procedures.",{"count":128,"type":22},222,[25],"Acute ischemic stroke (AIS) is a medical emergency that happens because of a sudden stop of blood flow to a part of the brain. This happens when a blood clot forms within the vessel (known as thrombotic occlusion) or a clot originating from somewhere else blocks a blood vessel (known as embolic occlusion). Strokes can cause serious health problems, death, and affect one's quality of life. To reduce long-term damage, it is important to restore blood flow to the brain as soon as possible.\n\nThe main aim of this study is to check how safe TAK-755 is, and how well adults with AIS tolerate it. Other aims are to check how well TAK-755 helps participants to manage their everyday activities and to understand whether it helps reduce the seriousness of their stroke symptoms when compared to placebo. A placebo looks like TAK-755, but does not have any medicine in it, to make sure participants do not know which treatment they are taking.\n\nThe participants will receive TAK-755 or placebo once; afterwards, their health will be monitored for about 3 months (90 days). All participants, regardless of their assignment to either TAK-755 or placebo, will receive the usual treatment for AIS as per the hospital's normal practice.",[132],"Acute Ischemic Stroke",[134],"Drug therapy","2026-08-13",{"date":137,"type":38},"2026-08-14",{"date":139,"type":38},"2026-05-17",{"date":141,"type":22},"2027-12-06",{"name":44,"class":45},60,{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":23,"phases":154,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},"100601268","phase-2-a-study-of-zasocitinib-in-adults-with-nonsegmental-vitiligo-100601268","NCT07108283","A Study of Zasocitinib in Adults With Nonsegmental Vitiligo","A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Zasocitinib in Participants With Nonsegmental Vitiligo","Inclusion criteria:\n\nParticipant willingness:\n\n1. Participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in the opinion of the investigator.\n2. Participant has provided written informed consent and any required privacy authorization before the initiation of any trial procedures.\n\n   Disease Characteristics:\n3. Participants must have a clinical diagnosis of nonsegmental vitiligo: F-VASI greater than or equal to (\\>=) 0.5 and a T-VASI \\>= 5 and less than or equal to (\\\u003C=) 50 at screening and Day 1.\n\n   Age and Reproductive Status:\n4. Participant is aged \\>=18 years to \\\u003C=75 years old at the time of consent.\n5. Participant meets the following birth control requirement:\n\n   An individual with potential for pregnancy who is now of nonchildbearing potential with laboratory confirmation of postmenopausal status; or an individual with potential for pregnancy who if sexually active with a nonsterilized individual who produces sperm, agrees to use a highly effective method of contraception from the signing of informed consent throughout the duration of the trial. The use of effective contraception will be required for assigned male sex at birth participants. In the European Union (EU) \u002F European Economic Area (EEA) and the United Kingdom (UK), for participants who elect to use hormonal contraception as a form of highly effective contraception, the investigator must document a favorable benefit-risk assessment to justify the participant's inclusion in the trial at screening and every 3 months during the trial.\n6. For participants in the EU\u002FEEA or UK, the investigator must have no reason to believe that the participant would be placed at risk by participating in the trial with regard to the European Commission decision as of 10 March 2023 on measures to minimize risk of serious side effects with Janus Kinase inhibitor (JAKi) (EMA\u002F142279\u002F2023) and the UK MHRA guideline on JAKi: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality as of 26 April 2023 (Drug Safety Update volume 16, issue 9).\n\nExclusion Criteria:\n\nTarget Disease-Related Exclusions:\n\n1. Participant has segmental vitiligo (including mixed vitiligo) or any other congenital or acquired cause of hypopigmentation or depigmentation that could interfere with the diagnosis or assessment of nonsegmental vitiligo.\n2. Participant has \\>50 percent (%) leukotrichia on the face or \\>50% leukotrichia of the body (includes the face), within the skin affected by vitiligo.\n3. Participant requires immunomodulatory or immunosuppressive systemic treatment, other than nonsteroidal anti-inflammatory drugs, during the trial period for an immune-related disease (for example, inflammatory bowel disease).\n4. Participant has a history of phototherapy (including, but not limited to, broadband Ultra-Violet \\[UV\\]-B, narrowband UV-B, psoralen and UV-A, excimer or other laser therapy, or tanning booth use) within 8 weeks before Day 1. Use of sunscreen products and protective apparel is recommended when sun exposure cannot be avoided.\n5. Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.\n6. History of any depigmenting or bleaching treatment for vitiligo or other skin disorder (for example, monobenzone or phenol).\n7. History of any surgical treatments for vitiligo.\n8. History of recent or progressive undiagnosed hearing loss.\n\n   Recent\u002FConcurrent Infectious Disease Exclusions:\n9. Tuberculosis (TB):\n\n   1. Participant has history of active TB infection, regardless of treatment status.\n   2. Participant has signs or symptoms of active TB (including, but not limited to, chronic fever, chronic productive cough, night sweats, or weight loss) as judged by the investigator.\n   3. Participant has evidence of Latent Tuberculosis Infection (LTBI) as evidenced by a positive QuantiFERON (QFT) result OR 2 indeterminate QFT results and participant does not have documentation of appropriate LTBI prophylaxis or is not able or not willing to initiate appropriate LTBI prophylaxis. Participant remains eligible if there are no signs\u002Fsymptoms of active TB AND documentation of no history of active TB can be provided AND (1) participant can provide documentation of prior and complete treatment for LTBI (appropriate in duration and type per current local country guidelines) or (2) participant has a positive QFT result or 2 indeterminate QFT results but has initiated prophylaxis (appropriate in duration and type per current local guidelines) a minimum of 2 weeks prior to Day 1. In the EU\u002F EEA and the UK, participants with evidence of LTBI, regardless of prophylaxis treatment status, must receive approval to participate in the trial from an infectious disease or other TB specialist (for example, pulmonologist).\n   4. Participant has had any imaging trial during or 6 months prior to screening, including x-ray, chest Computed Tomography (CT), magnetic resonance imaging, or other chest imaging suggesting evidence of current active or a history of active TB. X-ray is required for all participants regardless of QuantiFERON-TB Gold results unless the participant has had normal chest imaging in the 6 months prior to screening. CT imaging is allowed per local sites requirements.\n10. Herpes infections:\n\n    1. Participant has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and\u002For medical history) at screening or Day 1.\n    2. Participant has history of serious herpetic infection that includes any episode of disseminated disease, multidermatomal herpes zoster, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (defined as 2 episodes within 2 years).\n11. Non-herpetic viral diseases:\n\n    1. Participant has presence of Hepatitis C Virus (HCV) antibody and a positive confirmatory test result for HCV Ribonucleic Acid (RNA) (nucleic acid test or polymerase chain reaction). In the EU\u002FEEA and the UK, if the participant has total anti-HCV antibody positivity at screening but is confirmed to have no detectable HCV RNA by Polymerase Chain Reaction (PCR) testing, HCV RNA PCR testing will be assessed at additional visits per Schedule of Activities (SoA).\n    2. Participant has presence of positive Hepatitis B surface antigen (HBsAg), or indeterminate HBsAg, presence of Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) (regardless of serology), or positive anti- Hepatitis B core antibody (HBcAb) without concurrent positive HBsAb. In the EU\u002FEEA and the UK, if the participant has total anti-HBc antibody positivity at screening but is confirmed to have no detectable HBV DNA by PCR testing, the participant will repeat HBV DNA PCR testing at additional visits per SoA; if a participant has anti-HBsAb positivity at screening but is confirmed to have no detectable HBV DNA by PCR testing, unless the participant has documented completion of the HBV vaccination series by medical records, the participant will repeat HBV DNA PCR testing at additional visits per SoA. Note: For other countries in which there are hepatitis B screening guidelines, these can be done per local regulations or site's standard of care.\n    3. Participant has positive results for Human Immunodeficiency Virus (HIV) by serology, regardless of viral load.\n12. Other infectious diseases:\n\n    1. Participant has a history of active infection or febrile illness (with or without other symptoms) within 7 days prior to Day 1, as assessed by the investigator.\n    2. Participant has a history of serious or severe infection within 30 days prior to Day 1, as assessed by the investigator.\n    3. Participant has a history of bacterial, viral, or fungal infection that required hospitalization or treatment with intravenous antimicrobial therapy within 8 weeks prior to Day 1, or oral antimicrobial therapy within 30 days prior to Day 1.\n    4. Participant has a history of chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis\u002Fpneumonitis, osteomyelitis, or chronic skin ulcerations\u002Finfections or fungal infections (except superficial onychomycosis).\n    5. Participant has a history of an infected joint prosthesis unless that prosthesis has been removed or replaced at least 60 days prior to Day 1.\n    6. Participant has a history of opportunistic infections (for example, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).\n    7. Participant had a bacterial infection within 60 days prior to Day 1 for which he or she did not receive treatment.\n\n    Noninfectious Disorders Exclusions:\n13. Participant has any clinically significant medical condition, evidence of an unstable clinical condition (for example, cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, neurologic, nutritional, ophthalmologic or immunologic), or vital signs\u002Fphysical\u002Flaboratory\u002FElectrocardiogram (ECG) abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of trial results. These include but are not limited to:\n\n    1. Participant has a history of known or suspected condition\u002Fillness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy.\n    2. Participant has a history of new or unstable autoimmune disease (including but not limited to thyroid disease, lupus, sjogrens, myasthenia gravis, or rheumatoid arthritis).\n    3. Participant had a major surgery within 60 days prior to Day 1 or has a major surgery planned during the trial.\n    4. Participant has unstable, poorly controlled, or severe hypertension at screening, confirmed by 2 repeat assessments.\n    5. Participant has a history of Class III or IV congestive heart failure as defined by New York Heart Association criteria.\n    6. Participant has a history of cancer or lymphoproliferative disease with the exception of successfully treated nonmetastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix. In the EU\u002FEEA and the UK, for the participants with a history of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix, investigators must document a favorable benefit-risk assessment.\n    7. For participants with asthma, chronic obstructive pulmonary disease, or other pulmonary illnesses has ever required intubation for treatment, currently requires oral corticosteroids, or has required more than 1 course of oral corticosteroids within 6 months prior to Day 1, or participant has been hospitalized within 3 months prior to Day 1.\n    8. Participant has any of the following cardiovascular disease history:\n\n       * A new diagnosis of atrial fibrillation or an episode of atrial fibrillation with rapid ventricular response or other dysrhythmia, non-acute cardiac hospitalization (for example, pacemaker implantation), pulmonary embolism, or deep venous thrombosis within the past 6 months prior to screening.\n       * Any history of cerebrovascular event, myocardial infarction, coronary stenting, or aortocoronary bypass surgery. If, however, the investigator documents there are no suitable treatment alternatives available for the participant and it has been at least 6 months since the occurrence of any such event, the participant may enroll; in the EU\u002FEEA and the UK, investigators must document a favorable benefit-risk assessment.\n    9. Participant has ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the participant if they participated in the trial, in the opinion of the investigator.\n    10. Participant has any lifetime history of suicide attempts, suicidal behavior, or active suicidal ideation with intent and plan based on medical history or a YES response to Columbia-Suicide Severity Rating Scale (C-SSRS) Questions 5; the participant has evidence of current active suicidal ideation based on YES response to questions 2, 3, 4, or 5 on C-SSRS Since Last Visit performed on Day1; or is clinically deemed to have a suicide risk by the investigator.\n    11. Participant has a history of clinically significant drug or alcohol abuse within 12 months prior to Day 1.\n\n    Laboratory\u002FPhysical Exclusions:\n14. Participant has any of the following laboratory values at the screening visit:\n\n    1. Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) values \\>=3 times the Upper Limit of Normal (ULN).\n    2. Total bilirubin (unconjugated and\u002For conjugated) ˃1.5 times the ULN.\n    3. Hemoglobin (Hgb) \\\u003C9.0 gram\u002Fdeciliter (g\u002FdL) (\\\u003C90.0 gram\u002FLiter \\[g\u002FL\\]).\n    4. Absolute white blood cell count less than (\\\u003C) 3.0 \\* 10\\^9\u002FLiter (L) (\\\u003C3000\u002Fcubic millimeter \\[mm\\^3\\]).\n    5. Absolute neutrophil count of \\\u003C1.0 \\* 10\\^9\u002FL (\\\u003C1000\u002Fmm\\^3).\n    6. Absolute lymphocyte count of \\\u003C0.5 \\* 10\\^9\u002FL (\\\u003C500\u002Fmm\\^3).\n    7. Platelet count \\\u003C100 \\* 10\\^9\u002FL (\\\u003C100,000\u002Fmm\\^3).\n    8. Thyroid Stimulating Hormone (TSH) outside the normal reference range AND free T4 or T3 outside the normal reference range.\n    9. Estimated creatinine clearance \\\u003C45 milliliter\u002Fminute (mL\u002Fmin) based on the Cockcroft-Gault calculation.\n    10. Creatine Phosphokinase (CPK) \\> ULN. CPK may be repeated once; if repeat value is Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or lower (or \\\u003C=2.5 × ULN) and no higher than the initial value, participant remains eligible. Investigators should assess the participant for symptoms of rhabdomyolysis, and for modulating factors including concomitant medications or vigorous exercise that may affect CPK levels.\n15. Participant has any other significant laboratory abnormalities that, in the opinion of the investigator, might place the participant at unacceptable risk for participation in this trial.\n16. Participant does not tolerate venipuncture or inability to be venipunctured.\n\n    Allergies and Adverse Drug Reactions Exclusions:\n17. Participant has a history of significant drug allergy (such as anaphylaxis).\n18. Participant has a known or suspected allergy to zasocitinib or any of its components.\n\n    Other Exclusions:\n19. Participant has a positive pregnancy test result or plans to become pregnant during the trial period, including plans to undergo in vitro fertilization, donate ova (eggs), or sperm, or participant is lactating\u002Fnursing.\n20. Participant has given greater than 500 mL of blood or plasma within 30 days of screening (during a clinical trial or at a blood bank donation) or plans to donate blood during the course of the trial.\n21. Participant is compulsorily detained for treatment of either a psychiatric or physical (for example, infectious disease) illness, or is committed to an institution (for example, prison) by virtue of an order issued either by judicial or administrative authorities.\n22. Participant is a trial site employee, an immediate family member (for example, spouse, parent, child, sibling), or is in a dependent relationship with trial site employee who is involved in the conduct of this trial or may consent under duress.\n23. History of rhabdomyolysis.","75 Years",{"count":153,"type":22},200,[25],"Vitiligo is a long-term autoimmune condition that causes the skin to lose its color. The body's germ-fighting system (immune system) mistakenly attacks the skin cells (melanocytes) which produce the pigment that gives the skin color (melanin). This leads to the formation of patches of skin with less or no pigment (depigmentation). These patches can occur anywhere on the body. In the nonsegmental form of vitiligo, similar patches occur on both sides of the body (symmetrical patches).\n\nThe main aim of this study is to learn how safe zasocitinib is, how well it works and how well it is tolerated by adults with nonsegmental vitiligo.\n\nThe participants will receive the study treatment (either zasocitinib or placebo) for up to 1 year (52 weeks). The placebo looks like the zasocitinib capsule but does not have any medicine in it. Participants who receive placebo at the beginning will change to zasocitinib after about 6 months.\n\nDuring the study, participants will visit their study clinic 11 times.",[157],"Nonsegmental Vitiligo",[33],{"date":137,"type":38},{"date":161,"type":38},"2025-11-03",{"date":163,"type":22},"2027-11-09",{"name":44,"class":45},70,{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":23,"phases":175,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},"100590162","phase-3-a-study-of-mezagitamab-in-adults-with-kidney-condition-called-iga-nephropathy-100590162","NCT06963827","A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy","A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants With Primary IgA Nephropathy in Combination With Stable Background Therapy","* Inclusion Criteria:\n\nTo be eligible to participate in this trial, participants must meet all the following criteria:\n\n1. Either UPCR greater than or equal to (≥) 0.8 gram per gram (g\u002Fg) or urine protein excretion (UPE) ≥1 grams per day (g\u002Fday), calculated from at least one 24-hour urine collection during the screening period (or pre-screening, if applicable) (only applicable for the main trial).\n2. eGFR greater than (\\>)30 milliliters per minute per 1.73 meter square (mL\u002Fmin\u002F1.73m\\^2) at screening based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (only applicable for the main trial).\n3. No prior exposure to anti- cluster of differentiation 38 (CD38) therapy period (except for open-label cohort participants meeting Inclusion Criterion No. 10.a).\n4. The participant is aged ≥ 18 years or the local legal age as applicable.\n5. The participant (and the participant's legally acceptable representative, as applicable per local regulations or determination) has provided informed consent (that is, in writing, documented via a signed and dated informed consent form \\[ICF\\]) and any required privacy authorization before the initiation of any clinical trial procedures.\n6. Diagnosis of primary immunoglobulin A nephropathy (IgAN) supported by a renal biopsy report that is dated more recently than 10 years before the signing of the informed consent for the clinical trial. The redacted report must be made available for review. A renal biopsy must be performed during screening for participants without a biopsy report within 10 years.\n7. Participants must be on stable renin-angiotensin-aldosterone system (RAAS) inhibitor therapy with an angiotensin-converting enzyme inhibitor (ACE-I) and\u002For angiotensin receptor blocker (ARB) or endothelin receptor antagonist (ERA) or mineralocorticoid receptor antagonist (MRA) agent for at least 12 weeks before signing the ICF with dosing at the maximally tolerated or labeled dose as determined by the investigator, with the intent to continue stable dosing during the clinical trial. Those intolerant of RAAS inhibitor therapy are potentially eligible after consultation with the medical monitor. Intolerance is defined as a documented side effect causing discontinuation of the therapy.\n8. Resting blood pressure less than or equal to (≤)150 millimeters of mercury (mmHg) systolic and ≤100 mmHg diastolic.\n9. Female participants of childbearing potential who are not pregnant during screening (confirmed by negative serum human chorionic gonadotropin \\[hCG\\]) and on Visit 1 before first dose of trial intervention (confirmed by negative urine pregnancy test).\n10. Any one of the following (only applicable for participants in the open-label cohort):\n\n    1. Participants in Trial TAK-079-1006 who completed the Week 96 visit or the retreatment period with either UPCR \\>0.5 g\u002Fg or UPE \\>0.5 g\u002Fd calculated from a 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR \\>30 mL\u002Fmin\u002F1.73m\\^2 at screening based on the CKD-EPI formula.\n    2. UPCR \\\u003C0.8 g\u002Fg and UPE ≥0.75 and \\\u003C1.0 g\u002Fday, by 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR \\> 30 mL\u002Fmin\u002F1.73m\\^2 at screening based on the CKD-EPI formula.\n    3. UPCR ≥ 0.8 g\u002Fg or UPE ≥ 1.0 g\u002Fd by 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR ≥25 and ≤30 mL\u002Fmin\u002F1.73m\\^2 at screening based on the CKD-EPI formula.\n\n       * Exclusion Criteria:\n\nA participant who meets any of the following criteria will be excluded from participation in this trial:\n\n1. Kidney biopsy exhibiting significant concomitant renal disease other than IgAN (for example, diabetic nephropathy, lupus nephritis, minimal change disease).\n2. Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies), and immunoglobulin A (IgA) vasculitis.\n3. Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months before the signing of the ICF).\n4. Diagnosis of nephrotic syndrome defined as 24-hour proteinuria \\>3.5 g\u002Fday and hypoalbuminemia (\\\u003C3.0 grams per deciliter \\[g\u002FdL\\]) with or without peripheral edema.\n5. Renal or other organ transplantation prior to or expected during the clinical trial.\n6. Treatment with oral immunosuppressive agents (including cyclophosphamide, mycophenolate mofetil, cyclosporine, azathioprine, calcineurin inhibitors) or biologic therapy for immunomodulation (including immunomodulatory monoclonal or polyclonal antibodies) within 6 months (both B-cell and non-B-cell directed agents) before signing of the ICF.\n7. If the participant has received anti-CD20 treatment, the participant is excluded if either of the following apply:\n\n   1. The last dose was received within 6 months before the signing of the ICF.\n   2. The last dose was received between 6 and 12 months before the signing of the ICF and the participant has a CD19+ count below the lower limit of normal.\n\n   Note: Participants who have received the last dose of anti-CD20 treatment \\>12 months before the signing of the ICF are not excluded from clinical trial participation based on this criterion and are not required to undergo CD19+ testing.\n8. Within 4 months of the screening visit, use of either a) systemic corticosteroids at an average dose of 40 milligrams (mg) prednisone equivalent or higher for more than 14 days or b) oral budesonide delayed release capsules.\n9. The participant has received a live or live-attenuated vaccine within 4 weeks before signing the ICF or has any live or live-attenuated vaccine planned during the clinical trial.\n10. Participation in any other investigational drug trial (including vaccine trial) with receipt of at least 1 dose of investigational drug, or has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Visit 1.\n11. The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n12. The participant has had any of the following types of infections within the specified timeframes where applicable:\n\n    1. Active bacterial, viral, or fungal infection (except for the common cold and onychomycosis), or any other serious infection within 2 weeks of signing the ICF. Any anti-infective course for infection must be completed at least 2 weeks before Visit 1.\n    2. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) infection within 4 weeks of signing the ICF.\n    3. Opportunistic infection or treatment for an opportunistic infection less than or equal to (≤)12 weeks before signing the ICF.\n    4. Active tuberculosis (TB), any history of prior active TB, or any signs or symptoms of active TB infection (including but not limited to chronic fever, chronic productive cough, night sweats, weight loss, or malnutrition) as judged by the investigator.\n    5. For participants in European Union (EU) member states, positive or 2 indeterminant QuantiFERON results, unless there is documentation of prior complete treatment for latent TB, or participant has initiated prophylaxis based on local guidelines and in consultation with a pulmonology or infectious disease specialist prior to the first administration of IMP.\n13. In the opinion of the investigator, the participant is currently experiencing any medical condition that might interfere with participation in the trial (for example, significant ocular, cardiovascular, pulmonary, hematologic, gastrointestinal, endocrinologic, hepatic, renal, neurologic, malignancy, infectious disease, immunodeficiency, or alcohol and drug abuse), that poses an added risk for the participant or could confound the assessment of trial results.\n14. In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment.\n15. The participant has a history of major surgery within 3 months before screening (or longer, at the discretion of the investigator); or, either has a planned tonsillectomy or underwent a tonsillectomy within 6 months before screening.\n\n    Note: Major surgery typically requires at least 1 night in the hospital.\n16. History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for adequately treated non-melanoma skin cancer, superficial bladder cancer, and curatively treated cervical carcinoma-in-situ.\n17. The participant has a history of a severe allergic or anaphylactic reaction to recombinant proteins or excipients used in the mezagitamab or placebo formulation.\n18. The participant has (1) been diagnosed with or has suspected chronic obstructive pulmonary disease (COPD) or asthma and (2) has a prebronchodilatory forced expiratory volume in 1 second (FEV1) \\\u003C50% of predicted normal at screening.\n19. The participant is capable of breastfeeding but does not agree to forego breastfeeding from first dose of investigational medicinal product (IMP) through 30 days after the last dose of IMP.\n20. The participant is an individual with potential for pregnancy but does not agree to use at least 1 form of highly effective contraception and 1 barrier method of contraception (preferably male condom) when engaging in heterosexual sex for the protocol specified duration after the last dose of IMP.\n21. The participant is a sexually active, non-sterilized individual who produces sperm but does not agree to use a barrier method (preferably male condom) combined with at least 1 form of highly effective contraception for any partner(s) with potential for pregnancy when engaging in heterosexual sex for the protocol specified duration after the last dose of IMP.\n22. In the investigator's opinion, the participant (and the participant's legally acceptable representative, if applicable per local regulations or determination) is unwilling and\u002For unable to understand and fully comply with clinical trial procedures and requirements (including digital tools and applications).",{"count":174,"type":22},347,[26],"Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation). Over time, this inflammation may lead to kidney damage and cause the kidneys to no longer work properly. The main aim of this study is to check how well mezagitamab changes protein levels in the urine (proteinuria) compared to placebo in adults with primary IgAN. A placebo looks like medicine but doesn't have any active ingredients in it. Other aims are to check how safe mezagitamab is and how well participants with primary IgAN can tolerate it compared to placebo, and to find out if and how well mezagitamab continues to maintain kidney function over the long term compared to placebo.\n\nParticipants will be placed in 1 of the 2 treatment groups; the main group and the open-label group. In the main group, participants will be placed by chance in either the mezagitamab or placebo treatment group at a 2:1 ratio. This means that out of 3 participants, 2 will receive mezagitamab and 1 will receive placebo. Participants can be in the study for 2 years (104 weeks). Participants will receive study treatment for about half a year (22 weeks) and then be observed for the remainder of the study (about 1.5 years). During observation, participants will continue to have check-ups about every month.\n\nIn the open-label group, a small number of participants who either have lower levels of protein in their urine or have kidneys that do not filter the blood well, will receive mezagitamab treatment. This will include participants who have previously received mezagitamab in another study, TAK-079-1006. Every participant will receive mezagitamab in the same way as those in the main group receiving mezagitamab.\n\nDuring the study, participants will visit their study clinic several times.",[178],"Kidney Disease",[180,33],"TAK-079",{"date":137,"type":38},{"date":183,"type":38},"2025-07-15",{"date":185,"type":22},"2030-01-14",{"name":44,"class":45},176,{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":211},"100560759","phase-4-a-study-of-vedolizumab-in-adults-with-ulcerative-colitis-or-crohns-disease-in-the-community-setting-100560759","NCT06581328","A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting","A Phase 4 Study Evaluating Moderate to Severely Active Ulcerative Colitis or Crohn's Disease and the Use of Vedolizumab Subcutaneous Within a Community Setting","PANORAMA","Inclusion Criteria\n\nTo be eligible to participate in this study, participants must meet all the following criteria:\n\n1. In the investigator's opinion, the participant can understand and comply with protocol requirements.\n2. The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures.\n3. The participant is 18 to 80 years of age at the time of signing the ICF.\n4. The participant's immunization is up to date per vedolizumab US prescribing information (USPI).\n5. If participant is a woman of childbearing potential (WOCBP):\n\n   1. Agrees to use at least 1 form of highly effective contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab.\n   2. Agrees to avoid donating ova from signing the ICF throughout the duration of the study and for 18 weeks after the last dose of vedolizumab.\n   3. Has a negative urine pregnancy test within 3 days before first dose of vedolizumab.\n   4. Agrees to forego breastfeeding from first dose of vedolizumab through 18 weeks after the last dose of vedolizumab.\n6. If participant is a fertile man:\n\n   1. Agrees to use contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab\n   2. Agrees to avoid donating sperm throughout the study and for 18 weeks after the last dose.\n7. The participant has a diagnosis of moderate to severely active UC or CD defined by the following:\n\n   1. CD: A Crohn's Disease Activity Index (CDAI) score of 220 to 450 and a SES-CD \\>=6 (\\>=4 if isolated ileal disease) at screening OR\n   2. UC: A complete Mayo score (MS) of 6 to 12 with endoscopy subscore of 2 to 3 at screening\n8. UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.\n9. Demonstrated an inadequate response to, loss of response to, or intolerance of at least one of the following agents: corticosteroids, immunomodulators, and\u002For advanced therapy.\n\nExclusion Criteria\n\nParticipants who meet any of the following exclusion criteria will be excluded from participation in this study:\n\n1. Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab \\[AMG 181\\]) at any time prior to screening.\n2. Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments.\n3. Use of corticosteroid enemas\u002Fsuppositories within 2 weeks prior to screening (for UC and CD).\n4. In the investigator's opinion the participant meets any contraindication, warnings and precautions, drug interactions, or special population considerations per the vedolizumab USPI, or has (medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients) (Food and Drug administration \\[FDA\\] 2024).\n5. Received any investigational biologic therapy \\\u003C= 6 months prior to screening.\n6. The participant has received an advanced treatment for an approved indication other than CD or UC. Advanced therapy include: TNF inhibitors (e.g. infliximab, adalimumab, certolizumab pegol), and IL 12\u002F23 antagonist (e.g. ustekinumab, mirikizumab, risankizumab); and small molecules include JAK inhibitor (e.g. tofacitinib, upadacitinib) and sphingosine-1-phosphate (S1P) receptor modulator (e.g. etrasimod, ozanimod).\n7. The participant has any evidence of an active infection during screening.\n8. Ileostomy, colostomy, severe, or symptomatic stenosis of the intestine or short bowel syndrome.\n9. A surgical procedure requiring general anesthesia within 3 months prior to screening or is planning to or is at risk of undergoing major surgery during the study period.\n10. History of malignancy, except for the following: adequately treated nonmetastatic basal cell skin cancer; squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to screening; and history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to screening. Participants with a remote history of malignancy (example, greater than (\\>) 10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received; this must be discussed with the sponsor on a case-by-case basis prior to enrollment.\n11. History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion.\n12. Has laboratory abnormalities during the screening period.","80 Years",{"count":198,"type":22},400,[200],"PHASE4","Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission).\n\nParticipants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab.\n\nDuring the study, participants will visit their study clinic several times.",[203,204],"Ulcerative Colitis","Crohn's Disease",{"date":137,"type":38},{"date":207,"type":38},"2025-03-27",{"date":209,"type":22},"2028-06-01",{"name":44,"class":45},101,{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":222,"conditions":223,"keywords":225,"overallStatus":230,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":4},"100650828","phase-3-a-study-of-zasocitinib-in-adults-with-non-pustular-palmoplantar-psoriasis-100650828","NCT07752108","A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis","A Phase 3b, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Moderate-to-severe Non-pustular Palmoplantar Psoriasis (PPPsO)","Inclusion criteria:\n\nParticipant Willingness:\n\n1. The participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in the opinion of the investigator.\n2. The participant has provided informed consent and any required privacy authorization before the initiation of any trial procedures.\n\n   Disease Characteristics:\n3. The participant has a diagnosis of chronic non-pustular palmoplantar psoriasis for greater than or equal to (\\>=) 6 months prior to the screening visit.\n4. Participant has moderate-to-severe palmoplantar psoriasis, as defined by a ppIGA score \\>=3 at screening and Day 1 (Baseline).\n5. At screening and Day 1 (Baseline), the participant meets all of the following criteria:\n\n   * Moderate-to-severe plaque psoriasis as defined by an sPGA \\>=3\n   * Moderate-to-severe palmoplantar psoriasis, as defined by a PPASI \\>=8\n   * Plaque psoriasis BSA involvement of \\>=0.25 percent (%) and up to 10%, excluding the palms and soles\n6. Participant must be a candidate for phototherapy or systemic therapy.\n7. Previously had inadequately controlled disease by topicals, phototherapy and\u002For systemic treatments.\n\n   Age and Reproductive Status:\n8. Participant is aged 18 years or older at the time of consent.\n9. Participant meets the following birth control requirement: An individual with potential for pregnancy who is now surgically sterile; or a participant of nonchildbearing potential with laboratory confirmation of postmenopausal status; or, if sexually active with a nonsterilized individual who produces sperm, an individual with potential for pregnancy who agrees to use a highly effective method of contraception from the time of signing of the informed consent throughout the duration of the trial and for at least 10 days after the last study dose of trial intervention. The use of effective contraception will be required for assigned male sex at birth participants.\n\nExclusion criteria:\n\nTarget Disease-Related Exclusions:\n\n1. Participant has evidence of nonplaque PsO (pustular PsO, palmoplantar pustulosis, acrodermatitis continua of Hallopeau, erythrodermic, or guttate PsO) or presence of pustules.\n2. Participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.\n\n   Prohibited Psoriasis Treatments Exclusions:\n\n   For the below prohibited psoriasis treatments, the washout period prior to Day 1 must be within the time frame indicated or 5 half-lives, whichever is longer, regardless of whether they are prescribed for psoriasis or another condition:\n\n   Participant has received any of the following biologics or biosimilar versions within the time frame indicated:\n3. Antibodies to interleukin (IL)-12\u002F23.\n4. Antibodies to IL-23. There will be an allowance for up to 10 percent (%) of participants with previous IL-23 exposure to enroll. A washout period of 6 months prior to day 1 is required.\n5. Previous exposure to Janus Kinase (JAK) inhibitors.\n6. Previous exposure to Tyrosine Kinase 2 (TYK2) inhibitors.\n\n   Recent\u002FConcurrent Infections Disease Exclusions:\n7. History of active tuberculosis (TB), signs or symptoms of active TB. Evidence of latent TB infection, active Herpes infection at screening, history of serious herpetic infection or recurrent herpes zoster, evidence of Hepatitis C virus (HCV), evidence of Hepatitis B Virus (HBV) or HIV-positive status.\n\n   Noninfectious Disorders Exclusions:\n8. Participant has any clinically significant medical condition, evidence of an unstable clinical condition (for example, cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or immunologic), or vital signs\u002Fphysical\u002Flaboratory\u002FECG abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of trial results. These include but are not limited to:\n\n   1. Participant has significant\u002Funcontrolled psychiatric illness, in the opinion of the investigator.\n   2. Participant has any lifetime history of suicidal ideation, suicidal behavior, or suicidal attempts.\n   3. Participant has a history of clinically significant drug or alcohol abuse within 12 months prior to Day 1\n\n   Allergies and Adverse Drug Reactions Exclusions:\n9. Participant has history of significant drug allergy (such as anaphylaxis).\n10. Participant has a known or suspected allergy to zasocitinib or any of their components.",{"count":220,"type":22},40,[26],"Palmoplantar psoriasis (PPPsO) is a type of psoriasis that affects the palms of hands and soles of the feet. It can cause red, thick, scaly patches, and it is often associated with pain and itching. These symptoms can make daily life hard and can have a bigger effect on quality of life than psoriasis in some other areas of the body.\n\nTreatment can also be difficult because the skin on the palms and soles is thick, so treatments put on the skin (topical treatments) may not work as well.\n\nThe main aim of this study is to find out how well zasocitinib works in reducing the skin redness, thickening, scaling, as well as fissures (narrow, elongated tears) on palms and soles of adults. Other aims are to learn if zasocitinib reduces the surface area of psoriasis on the palms and soles in adults with mainly Palmoplantar psoriasis.\n\nThe study is conducted in 2 parts with a possibility of continued treatment (long-term extension). In Part 1, participants will receive zasocitinib for 4 months (16 weeks). Participants who finish Part 1 may be able to continue to Part 2 if the study doctor thinks they would benefit. Participants who continue to Part 2, will keep taking zasocitinib until they have been treated for about 1 year (52 weeks). After that, participants may choose to keep taking zasocitinib for another year (52 weeks). Participants will be followed for about 1 month (4 weeks) after the end of treatment.\n\nDuring the study, participants will visit their study clinic 16 times.",[224],"Palmoplantar Psoriasis",[33,226,227,228,229],"Psoriasis","Plaque Psoriasis","Moderate to Severe Plaque Psoriasis","Plaque Psoriasis with Palmoplantar (Non-Pustular)","NOT_YET_RECRUITING","2026-08-12",{"date":137,"type":38},{"date":234,"type":22},"2026-09-01",{"date":236,"type":22},"2029-02-15",{"name":44,"class":45},{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":247,"phases":4,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":230,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":253,"leadSponsor":255,"locationsCount":4},"100641121","a-study-of-fruquintinib-in-adults-with-metastatic-colorectal-cancer-in-poland-100641121","NCT07623174","A Study of Fruquintinib in Adults With Metastatic Colorectal Cancer in Poland","FRAMEWORK-CRC: Fruquintinib Real-World Outcomes in mCRC - A Prospective Study of One-Year Progression-Free Survival and Overall Survival in Polish Patients","Inclusion Criteria:\n\n1. Adult participants (aged 18 years and older) with mCRC who are eligible for treatment with fruquintinib under the national drug program B.4 and will receive fruquintinib as third or subsequent line treatment after progression on or intolerance to trifluride\u002Ftipiracil.\n2. Participants who signed informed consent to participate in the study at the time of enrollment and prior to the fruquintinib treatment initiation.\n3. Participants for whom adequate medical records are available to support the data collection requirements.\n\nExclusion Criteria:\n\n1\\. Participant currently participates or plans to participate in an interventional clinical trial.",{"count":246,"type":22},110,"OBSERVATIONAL","Metastatic colorectal cancer or mCRC is a cancer that starts in the parts of the large intestine (the colon or rectum) and has already spread to other parts of the body. This cancer can be hard to treat because it can behave differently from one person to another. Over time, treatments may stop working, and side effects can build up. In later treatment stages, there are only a few standard medicine options available. Because of this, studies often look at both how long people live and how treatment affects quality of life.\n\nThe main aim of this study is to see how long adults in Poland with mCRC live without their cancer getting worse (progression-free survival or PFS) when they receive fruquintinib after at least two previous treatments. Fruquintinib (TAK 113) is a medicine taken by mouth that is designed to slow tumor growth.\n\nOther aim is to find out how long adults in Poland with mCRC live while being treated with fruquintinib (overall survival or OS). The study also wants to record how fruquintinib is used in routine care in adults with mCRC in Poland (for example when treatment starts, changes in doses, and how long treatment continues). Another aim is to learn about people with mCRC, such as their medical history and past treatment as well as their quality of life while they are in the study.\n\nThe study will look at data already existing in the participants' medical charts.",[250],"Metastatic Colorectal Cancer",{"date":137,"type":38},{"date":35,"type":22},{"date":254,"type":22},"2028-03-31",{"name":44,"class":45},{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":269,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":282,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":288},"100588969","phase-3-a-follow-up-study-of-mezagitamab-in-adults-with-chronic-primary-immune-thrombocytopenia-100588969","NCT06948318","A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia","A Phase 3, Open-label, Multicenter Continuation Trial to Evaluate the Long-term Safety and Efficacy of Mezagitamab Subcutaneous Injection in Adults With Chronic Primary Immune Thrombocytopenia","* Key Inclusion Criteria:\n\n  1\\. The participant has completed TAK-079-3002 (end of trial \\[EOT\\]) or TAK-079-1004 (EOT). Participants from TAK-079-1004 must have had a response to mezagitamab as demonstrated by meeting the criteria for \"platelet response\" specified for that trial during either the main study or open-label extension.\n* Key Exclusion criteria:\n\nFor TAK-079-3002 participants:\n\n1\\. The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab formulation.\n\nFor TAK-079-1004 participants:\n\n1. The participant has had any thrombotic or embolic event within 12 months before signing the ICF.\n2. The participant has had a splenectomy within 3 months before signing the ICF.\n3. The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n4. History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for treated non-melanoma skin cancer or cervical carcinoma in situ.\n5. In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.\n6. The participant has received anti-cluster of differentiation (CD) 20 treatment within 12 months before screening and either of the following applies:\n\n   1. The last dose was received within 6 months before screening.\n   2. The last dose was received between 6 and 12 months before screening and the participant has a CD19+ count below the lower limit of normal.\n7. The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before Visit 1.\n8. The participant has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Visit 1.\n9. The participant has used anticoagulants (for example, vitamin K antagonists, direct oral anticoagulants) within 3 weeks prior to Visit 1.\n\n10 The participant has received a live or live-attenuated vaccine within 4 weeks prior to the first dose of trial treatment or has any live or live-attenuated vaccine planned during the trial.\n\n11\\. The participant has used the following immunosuppressive agents as specified prior to Visit 1: alkylating agents (for example, cyclophosphamide) within 8 weeks, vinca alkaloids (for example, vincristine) within 4 weeks, sulfones (for example, dapsone) within 3 weeks, antiproliferative agents: (for example, mycophenolate mofetil and azathioprine) within 2 weeks, and calcineurin inhibitors: (for example, cyclosporine) within 2 weeks.\n\n12\\. The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab formulation.\n\nOther protocol defined inclusion\u002Fexclusion criteria may apply.",{"count":264,"type":22},150,[26],"Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a lower number of platelets, making it easier to bruise or bleed. The main aim of this study is to check how safe mezagitamab is and how well it is tolerated by adults with chronic primary ITP, if given over a longer time. Other aims are to learn how effective treatment with mezagitamab is and how the body processes it (called pharmacokinetics or PK) over a longer time.\n\nParticipants of the following previous mezagitamab studies will be invited to join this continuation study: TAK-079-3002 and TAK-079-1004. In this continuation study, participants will receive mezagitamab when certain protocol criteria are met.\n\nDuring the study, participants will visit their study clinic several times.",[268],"Immune Thrombocytopenic Purpura (ITP)",[180,270,271,272,273,85,274,275,276,277,278,279,280,281],"Immune Thrombocytopenia","Chronic Primary Immune Thrombocytopenia","Blood Platelet Disorders","Hematologic Diseases","Purpura","Hemorrhagic Disorders","Autoimmune Diseases","Immune System Diseases","Hemorrhage","Skin Manifestations","Purpura, Thrombocytopenic, Idiopathic","Purpura, Thrombocytopenic",{"date":137,"type":38},{"date":284,"type":38},"2025-08-14",{"date":286,"type":22},"2029-07-29",{"name":44,"class":45},114,{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":23,"phases":298,"briefSummary":299,"conditions":300,"keywords":302,"overallStatus":230,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":4},"100651882","phase-2-a-study-of-rusfertide-in-adults-with-polycythemia-vera-in-china-100651882","NCT07765602","A Study of Rusfertide in Adults With Polycythemia Vera in China","A Phase 2 Open-Label Trial to Evaluate the Efficacy and Safety of the Hepcidin Mimetic Rusfertide (TAK-121) in Chinese Patients With Polycythemia Vera","* Inclusion Criteria\n\n  1. Chinese male and female participants aged 18 years or older at the time of signing of informed consent.\n  2. Participant understands the trial procedures, is willing and able to adhere to trial requirements, and agrees to participate in the trial by providing written informed consent.\n  3. Meets the revised 2016 World Health Organization criteria for the diagnosis of polycythemia vera (PV).\n  4. Participant with inadequate hematocrit control who meets all of the following criteria:\n\n     1. Greater than or equal to (≥) 3 times documented hematocrit ≥45 percent (%) within 28 weeks prior to trial intervention or ≥5 times documented hematocrit ≥ 45% hematocrit within 1 year prior to trial intervention.\n     2. Documented hematocrit ≥45% within 3 months prior to trial intervention.\n     3. Phlebotomy or erythrocytapheresis, if performed, must not have occurred within 6 days of trial intervention administration (the day of phlebotomy or erythrocytapheresis and the day of trial intervention administration should not be included in the 6-day count).\n  5. Complete blood count immediately prior to trial intervention administration must meet the following criteria:\n\n     1. Hematocrit less than (\\\u003C) 45%.\n     2. White blood cell count within the range of 4000\u002Fmicroliter (µL) to 20,000\u002FµL (inclusive), and\n     3. Platelet count within the range of 100,000\u002FµL to 1,000,000\u002FµL (inclusive).\n  6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.\n  7. Participants receiving cytoreductive therapy (CRT) at the time of trial intervention administration must be on a stable PV treatment regimen, including:\n\n     1. Hydroxyurea: at least 8 weeks.\n     2. JAK inhibitor: at least 8 weeks.\n     3. Interferon: at least 24 weeks.\n  8. Women of childbearing potential (WOCBP) agrees to use at least 1 form of highly effective contraception during the trial and for 30 days after the last dose of trial intervention.\n  9. A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial and for a period of 30 days after receiving the last dose of trial medication.\n  10. A fertile male participant agrees to use a condom, preferably combined with at least 1 form of acceptable contraception for any WOCBP partner(s) during the trial and for 90 days after the last dose of trial intervention.\n  11. A male participant must agree not to donate sperm for the purpose of reproduction during the trial and for a minimum of 90 days after receiving the last dose of trial medication.\n* Exclusion Criteria\n\n  1. Clinically significant laboratory abnormalities at screening, including but not limited to:\n\n     1. Estimated glomerular filtration rate (eGFR): \\\u003C15 milliliters per minute per 1.73 square meters (mL\u002Fmin\u002F1.73 m\\^2) according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation 2021. Estimated Glomerular Filtration Rate (eGFR) =142 × (serum creatinine \\[Scr\\] \u002F A)\\^B × 0.9938\\^age × (1.012 if female), where A and B are the following: Female: Scr less than equal to (≤) 0.7, A equals to (=) 0.7, B=-0.241; Scr greater than (\\>) 0.7, A=0.7, B=-1.2. Male: Scr ≤0.9, A=0.9, B=-0.302; Scr \\>0.9, A=0.9, B=-1.2. Creatinine unit conversion: milligrams per deciliter (mg\u002FdL) =micromoles per liter (μmol\u002FL)\u002F88.4.\n     2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.5×upper limit of normal (ULN).\n     3. Total bilirubin \\>1.5×ULN.\n  2. Those who require phlebotomy at hematocrit levels \\\u003C45%.\n  3. Clinically significant thrombosis (for example, deep vein thrombosis or splenic vein thrombosis) within 2 months prior to trial intervention.\n  4. Active or chronic bleeding within 2 months prior to trial intervention.\n  5. Those who meet the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment.\n  6. In situ or Stage 1 squamous cell carcinoma of the skin, in situ or Stage 1 basal cell carcinoma of the skin, or in situ melanoma of the skin, as determined by the dermatologic examination required at screening unless the cancer is adequately treated prior to trial intervention.\n  7. Any infection requiring systemic therapy within 1 month of dosing except controlled human immunodeficiency virus (HIV), hepatitis B, and hepatitis C. Prophylactic therapies are allowed.\n  8. Any serious or unstable medical condition (for example, poorly controlled HIV infection) or uncontrolled psychiatric condition that, in the judgement of the investigator, would impair the participant's ability to participate in the trial.\n  9. Major surgical procedure within 2 months prior to trial intervention, unless the participant has fully recovered from the surgery; or planned major elective surgery during the trial.\n  10. History of invasive malignancies within the last 5 years, except\n\n      1. Localized cured cancer (for example, prostate cancer and cervical cancer).\n      2. Localized cured in situ or Stage 1 squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or in situ melanoma of the skin.\n  11. Pregnant females.\n  12. Those capable of breastfeeding but do not agree to forego breastfeeding from the first dose of trial intervention through 30 days after the last dose.\n  13. Active alcohol or drug addiction that would interfere with their ability to comply with trial requirements.\n  14. Those who do not complete at least 4 days of Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 assessments within 1 week prior to trial intervention.\n  15. Receipt of an investigational agent within 2 months or 5 half-lives, whichever is longer, prior to trial intervention.\n  16. Receipt of busulfan or \\^ 32 phosphorus within 7 months prior to screening.\n  17. Known hypersensitivity to rusfertide or any of its excipients.\n  18. Any lesion or mass detected by physical examination or imaging during screening that is suspicious for malignancy, unless it has been evaluated and confirmed to be nonmalignant.",{"count":297,"type":22},24,[25],"Polycythemia vera (PV) is a long-term condition in which the bone marrow makes too many red blood cells (RBCs). Bone marrow is the soft tissue inside the large bones where blood cells are made. When there are too many RBCs, called erythrocytosis, the blood can become thicker and move less easily through blood vessels and organs. This can raise the risk of blood clots (thrombosis) in veins or arteries. Sometimes, these clots can be life-threatening and may cause a stroke or heart attack. Treatment aims to keep the percentage of RBCs in the blood (hematocrit) in a safe range. For adults with PV, this means keeping the hematocrit below 45%. This helps lower the blood thickness and the risk of thrombosis. PV can also be linked to low iron levels (iron deficiency), because the body uses iron to make more RBCs. Many people with PV are treated with blood removal (phlebotomy) to lower RBC levels in the blood. This can worsen the iron deficiency, because each blood removal also takes iron out of the body.\n\nRusfertide is a medicine that lowers the amount of iron available in the blood. It works like hepcidin, a natural hormone that helps control iron levels in the body. By limiting iron available for RBC production, rusfertide may help keep hematocrit below 45% and may improve symptoms. It may also reduce, or even remove, the need for phlebotomy in people.\n\nThe main aim of this study is to check how well rusfertide works to lower the number of phlebotomies needed in Chinese adults with PV. Other aims are to understand how well rusfertide works to keep hematocrit levels under control and how safe it is. The study also wants to learn how rusfertide moves through the body (pharmacokinetics) and if it causes the body's defense system to react to it (immunogenicity).\n\nDuring the study, participants will receive rusfertide for up to 1 year (52 weeks) and will have to visit their study clinic several times. Blood samples will be taken several times during the study.",[301],"Polycythemia Vera",[33],"2026-08-11",{"date":137,"type":38},{"date":306,"type":22},"2027-03-01",{"date":308,"type":22},"2028-08-01",{"name":44,"class":45},{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":317,"enrollmentInfo":318,"targetDuration":4,"studyType":23,"phases":320,"briefSummary":321,"conditions":322,"keywords":323,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":330},"100523395","phase-4-a-study-of-vedolizumab-with-tofacitinib-in-adults-with-ulcerative-colitis-uc-100523395","NCT06095128","A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)","An Open-Label, Phase 4, Single-Arm, Multicenter Study to Evaluate the Induction of Response and Remission of Vedolizumab Dual Targeted Therapy With Tofacitinib in Adult Patients With Moderately to Severely Active Ulcerative Colitis","Inclusion Criteria:\n\n1. Has a confirmed diagnosis of UC established at least 3 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report.\n2. Has moderately to severely active UC as determined by a complete Mayo score \\[including physician's global assessment (PGA)\\] of 6 to 12 with a rectal bleeding subscore ≥1 and a centrally assessed endoscopic subscore ≥2 at screening.\n3. Has evidence of UC extending proximally to the rectum \\[≥15 centimeter (cm) of involved colon\\].\n4. Participants with extensive colitis or pancolitis of \\>8 years duration or left sided colitis \\>12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit.\n5. Participants with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age \\>50 years, or other known risk factors must be up to date on colorectal cancer surveillance.\n6. Has demonstrated an inadequate response to, loss of response to, or intolerance to at least 1, but no more than 2 TNFα antagonists. Participants without prior failure or intolerance to biologics are not eligible. Participants who discontinued TNFα antagonist therapy for reasons other than failure or intolerance (eg, pregnancy) may be eligible after discussion with the medical monitor.\n\n   Note: After the interim analysis, participants with inadequate response, loss of response, or intolerance to conventional UC therapy without prior exposure to biologics may be enrolled if deemed appropriate. Participants who discontinued biologics for reasons other than failure or intolerance (eg, pregnancy) may be eligible after discussion with the Medical Monitor.\n7. If using corticosteroids must be on a stable dose of oral corticosteroids up to a maximum of 40 mg daily of prednisone or 9 mg daily of budesonide, or equivalent for at least 2 weeks prior to screening endoscopy and must be willing to follow a mandatory taper of corticosteroids from enrollment.\n\nExclusion Criteria:\n\nGastrointestinal Exclusion criteria:\n\n1. Has any of the following UC-related complications:\n\n   1. Acute severe UC.\n   2. The participant has had extensive colonic resection, subtotal or total colectomy.\n   3. The participant has clinical evidence of abdominal abscess or toxic megacolon.\n   4. The participant has an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.\n   5. Short bowel syndrome.\n2. Has Crohn's colitis, indeterminate colitis, ischemic colitis, nonsteroidal anti-inflammatory drug (NSAID) induced colitis, idiopathic colitis (i.e, colitis not consistent with UC), radiation colitis, microscopic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption. Participants with a history of colonic mucosal dysplasia are also excluded.\n3. Has uncontrolled primary sclerosing cholangitis.\n\nInfectious Disease Exclusion Criteria:\n\n1. Has any evidence of an active systemic infection during screening. Participants with nonsystemic infections (eg, active fungal infection of nail beds) may be eligible, if in the opinion of the investigator, inclusion of the participant will not interfere with the collection or interpretation of study results and poses no risk to the participant.\n2. Has active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following:\n\n   1. History of TB.\n   2. A diagnostic TB test performed during screening that is positive, as defined by:\n\n   i. A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests or ii. A tuberculin skin test reaction ≥10 mm (≥5 mm in subjects receiving the equivalent of \\>15 mg daily prednisone).\n3. A positive test for hepatitis B virus (HBV).\n4. A positive test for hepatitis C virus (HCV).\n5. Evidence of, or treatment for, Clostridium difficile infection or other intestinal pathogen within 28 days prior to first dose of study treatment. Participants who test positive for C. difficile or other intestinal pathogens at screening and receive treatment may be enrolled or rescreened (if required) following confirmation of infection resolution.\n6. Evidence of active Cytomegalovirus (CMV) infection at screening.\n\nMedication exclusion criteria:\n\n1. Has received immunomodulators (eg, 6-mercaptopurine, azathioprine, and methotrexate) within 4 weeks prior to first dose or immunosuppressants (eg, cyclosporine, tacrolimus) within 8 weeks prior to first dose.\n2. Any medicinal product, herbal medication, or natural health product which might interfere with cytochrome P450 genotype 3A4 (CYP3A4) within 2 weeks prior to enrollment, except for any CYP3A4 modulator used to treat a C. difficile or an intestinal pathogen infection at screening.\n3. Has received any of the following medical therapies for UC:\n\n   1. IV antibiotics within 8 weeks prior to enrollment.\n   2. Any rectal therapy for treatment of UC within 2 weeks prior to screening endoscopy.\n   3. Chronic NSAID use defined as daily use for \\>2 consecutive weeks (Note: occasional use \\[\\\u003C2 consecutive weeks\\] of NSAIDs and acetaminophen \\[\\\u003C100 mg daily\\] for headache, arthritis, myalgias, or menstrual cramps and chronic low dose aspirin use \\[81-162.5 mg daily\\] for cardiovascular prophylaxis are permitted).\n4. Has received a live virus or live bacterial vaccine within 4 weeks prior to enrollment or planned vaccination during the study and for 12 weeks after last dose.\n\nGeneral Exclusion Criteria:\n\n1. Has any of the following cardiovascular or thrombotic conditions:\n\n   1. Recent (within past 6 months) cerebrovascular accident, myocardial infarction, or coronary stenting.\n   2. Recent (within past 6 months) moderate to severe congestive heart failure (New York Heart Association class III or IV).\n   3. Prior history of thrombotic events, including deep vein thrombosis and pulmonary embolism.\n   4. Known inherited conditions that predispose to hypercoagulability.\n2. History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and\u002For splenomegaly.\n3. A surgical procedure requiring general anesthesia within 3 months prior to screening or is planning to undergo major surgery during the study period.\n4. Any investigational procedure ≤4 weeks prior to screening that, in the investigator's opinion, may interfere with interpretation of study results.","65 Years",{"count":319,"type":22},65,[200],"The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with tofacitinib in adults with moderate and severe ulcerative colitis (UC). Another aim is to learn about treatment with Vedolizumab alone after the double treatment.\n\nAll participants will receive vedolizumab together with tofacitinib for 8 weeks and will be checked for response. Participants who show a response to the treatment after 8 weeks will be treated with vedolizumab alone for an additional 44 weeks.\n\nEach participant will be followed up for at least 26 weeks after the last dose of vedolizumab.",[203],[33],{"date":231,"type":38},{"date":326,"type":38},"2024-06-12",{"date":328,"type":22},"2027-07-09",{"name":44,"class":45},46,{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":103,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":340,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":350},"100519607","phase-4-a-study-of-vedolizumab-intravenous-iv-and-adalimumab-or-vedolizumab-and-ustekinumab-in-adults-with-crohns-disease-100519607","NCT06045754","A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease","An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Dual Targeted Therapy With Vedolizumab Intravenous (IV) and Adalimumab Subcutaneous (SC) or Vedolizumab IV and Ustekinumab IV\u002FSC in Moderate to Severe Crohn's Disease (CD)","Inclusion Criteria:\n\nPart A:\n\n1. Has a confirmed diagnosis of CD at least 3 months before screening, based on endoscopy results.\n2. Has moderately to severely active CD at Screening, defined as an SES-CD \\>=6 (\\>=4 if isolated ileal disease).\n3. Has demonstrated at least 1 of the following (a, b, or c) to at least 1 IL antagonist or at least 1 tumor necrosis factor (TNF) antagonist, at doses approved for the treatment of CD:\n\n   1. Inadequate response after completing the full induction regimen;\n   2. Loss of response (recurrence of symptoms during scheduled maintenance dosing after prior clinical benefit); or\n   3. Intolerance (a significant adverse event that precluded further use, including but not limited to serious infection including opportunistic infections, malignancy, infusion-related and hypersensitivity reactions including anaphylaxis, and liver injury).\n\n   Note: Participants with an inadequate response to \\>2 classes of advanced therapies or \\>1 agent in the same class are not eligible. Participants who discontinued a third class of advanced therapy for reasons other than inadequate response may be eligible after discussion with the Medical Monitor.\n\n   Part B:\n4. In the investigator's opinion, the participant exhibits a therapeutic benefit at Week 26.\n\nExclusion Criteria:\n\n1. CDAI score \\> 450.\n2. A current diagnosis of ulcerative colitis or indeterminate colitis.\n3. Clinical evidence of an abdominal abscess.\n4. Known fistula (other than perianal fistula) or phlegmon.\n5. Known perianal fistula with abscess.\n6. Ileostomy, colostomy, or severe, or symptomatic stenosis of the intestine.\n7. Previous extensive bowel resection with 2 entire segments missing, of the following: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.\n8. Short bowel syndrome.\n9. Any planned surgical intervention for CD, except for seton placement for perianal fistula without abscess.\n10. History or evidence of adenomatous colonic polyps that have not been removed.\n11. History or evidence of colonic mucosal dysplasia.\n12. Intolerance or contraindication to ileocolonoscopy.\n13. Any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency infection).\n14. Active or latent tuberculosis (TB), regardless of treatment history.\n15. A positive test for hepatitis B virus (HBV) as defined by the presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) test.\n16. A positive test for hepatitis C virus (HCV), as defined by a positive hepatitis C virus antibody (HCVAb) test and detectable HCV ribonucleic acid (RNA).\n17. Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab \\[AMG 181\\], anti- mucosal addressin cell adhesion molecule-1 \\[MAdCAM-1\\] antibodies, or rituximab) for the treatment of CD.\n18. History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion. If a participant has symptoms consistent with PML, a PML checklist must be completed and submitted to the PML independent adjudication committee. If the PML IAC deems the participant to have PML, the participant is ineligible.",{"count":339,"type":22},100,[200],"The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment.\n\nThe study is conducted in two parts. In Part A, participants will receive the dual targeted treatment (vedolizumab together with either adalimumab or ustekinumab). In part B, participants will receive vedolizumab only. Part B will include participants who responded to the treatment in Part A.\n\nEach participant will be followed up for at least 26 weeks after the last dose of treatment.",[204],[33],{"date":231,"type":38},{"date":346,"type":38},"2024-04-18",{"date":348,"type":22},"2027-06-28",{"name":44,"class":45},48,{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":23,"phases":360,"briefSummary":361,"conditions":362,"keywords":364,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":375},"100567692","phase-3-a-study-of-zasocitinib-in-adults-with-psoriatic-arthritis-who-have-or-have-not-been-treated-with-biologic-medicines-100567692","NCT06671496","A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines","A Multi-Center, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Stratified by Prior Biologic Use (LATITUDE-PsA-3002)","Inclusion Criteria:\n\nAge:\n\n1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF).\n\n   Disease Characteristics:\n2. The participant has a diagnosis of PsA.\n3. The participant must have signs and symptoms of PsA for at least 3 months prior to screening.\n4. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).\n5. The participant has active arthritis as shown by a minimum of \\>=3 tender joints in TJC68 and \\>=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.\n6. The participant has at least 1 active lesion of plaque PsO \\>=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.\n\n   Medications for PsA:\n7. The participant has had at least one of the following:\n\n   1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union \\[EU\\]\u002F European Economic Area \\[EEA\\]), OR\n   2. Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD), OR\n   3. Biological disease-modifying antirheumatic drug (DMARD)-inadequate response (Bio-IR): Inadequate response to up to 2 biologic DMARDs.\n\nExclusion Criteria:\n\nPsA and PsO:\n\n1. The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.\n2. The participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).",{"count":359,"type":22},600,[26],"Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO).\n\nThe main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA based on their previous experience with specific treatments.\n\nThe participants will be treated with either zasocitinib, or placebo. Participants will be in the study for up to 60 weeks.",[363],"Psoriatic Arthritis",[33,365,366,367],"Latitude Research Program","Latitude PsA","Latitude PsA-3002","2026-08-07",{"date":303,"type":38},{"date":371,"type":38},"2025-03-10",{"date":373,"type":22},"2028-01-26",{"name":44,"class":45},123,{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":23,"phases":385,"briefSummary":386,"conditions":387,"keywords":388,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":396},"100567691","phase-3-a-study-of-zasocitinib-in-adults-with-psoriatic-arthritis-who-have-not-taken-biologic-medicines-100567691","NCT06671483","A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines","A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001)","Inclusion Criteria:\n\nAge:\n\n1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF). In South Korea, the age requirement for adult participants is \\>=19 years of age.\n\n   Disease Characteristics:\n2. The participant has a diagnosis of PsA.\n3. The participant must have signs and symptoms of PsA for at least 3 months prior to screening.\n4. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).\n5. The participant has active arthritis as shown by a minimum of \\>=3 tender joints in TJC68 and \\>=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.\n6. The participant has at least 1 active lesion of plaque PsO \\>=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.\n\n   Medications for PsA:\n7. The participant has had at least one of the following:\n\n   1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union \\[EU\\]\u002F European Economic Area \\[EEA\\]), OR\n   2. Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD).\n\nExclusion Criteria:\n\nPsA and PsO:\n\n1. The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.\n2. The participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).",{"count":384,"type":22},1088,[26],"Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO).\n\nThe main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs.\n\nThe participants will be treated with either zasocitinib, active comparator, or placebo. Participants will be in the study for up to 60 weeks.",[363],[33,365,366,389],"Latitude PsA-3001",{"date":303,"type":38},{"date":392,"type":38},"2025-03-03",{"date":394,"type":22},"2028-01-28",{"name":44,"class":45},188,{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":404,"targetDuration":4,"studyType":23,"phases":406,"briefSummary":407,"conditions":408,"keywords":411,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":350},"100591442","phase-3-a-study-of-gammagard-liquid-immune-globulin-infusion-10-to-prevent-infections-in-adults-with-multiple-myeloma-100591442","NCT06980480","A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma","A Multicenter, Randomized, Controlled, Open-label, Group-Sequential, Phase 3 Study to Investigate the Efficacy, Safety, and Tolerability of Intravenous Gammagard Liquid (Immune Globulin Infusion, 10%) for Primary Infection Prophylaxis Compared With Secondary Infection Prophylaxis in Adult Subjects With Multiple Myeloma Receiving B-Cell Maturation AntigenxCD3-Directed Bispecific Antibody Therapy","Inclusion Criteria:\n\n1. The participants must have a documented diagnosis of Multiple Myeloma (MM) according to the guidelines by the International Myeloma Working Group (IMWG) before enrollment.\n2. Participant who recently started teclistamab monotherapy within the first 8 weeks of their planned treatment schedule and are planned to receive teclistamab for the next 12 months.\n3. The participant has provided informed consent (that is, in writing, documented via a signed and dated Informed Consent Form \\[ICF\\]) and any required privacy authorization before the initiation of any study procedures.\n4. The participant is at least 18 years of age at the time of signing the ICF.\n5. If a person of childbearing potential engages in sexual relations that carry risk of pregnancy, they agree to the following for the period from screening until 30 days after the last dose of study drug:\n\n   1. To use a highly effective contraceptive method.\n   2. To avoid donating ova.\n\nExclusion Criteria:\n\n1. The participant has not achieved at least a minimal response to teclistamab during the screening period after signing the ICF and within 8 weeks of the first step-up dose of teclistamab.\n2. The participant has a current serious infection or greater than (\\>) 1 serious infection in the past 3 months before screening.\n3. The participant has a documented polyclonal IgG level less than (\\\u003C) 150 milligrams per deciliter (mg\u002FdL) at the most recent assessment before teclistamab initiation (within 4 weeks) as assessed by the investigator according to the site's standard practice.\n4. The participant is currently receiving immunoglobulin products or has received immunoglobulin products within 16 weeks before screening.\n5. The participant has received a hyperimmune or specialty high-titer immunoglobulin product (example, cytomegalovirus immune globulin, varicella-zoster immune globulin, hepatitis B immune globulin) within 30 days before screening.\n6. The participant has received live viral vaccines within 30 days before screening.\n7. The participant has an Eastern Cooperative Oncology Group performance status score of \\>2.\n8. The participant has an active viral or bacterial infection or symptoms\u002Fsigns of such an infection requiring treatment with anti-infectives within 1 week before enrollment.\n9. The participant has received other B Cell Maturation Antigen (BCMA)\\*Cluster of Differentiation (CD3)-directed Bispecific Antibody therapy (BsAb), BCMA-targeted chimeric antigen receptor T-cell (CAR T-cell), or BCMA-targeted antibody drug conjugate (ADC) therapy within 1 year prior to screening.\n10. The participant is scheduled to undergo plasmapheresis during the course of study or has undergone plasmapheresis in the last 16 weeks before screening.\n11. The participant may be excluded from the study if, in the opinion of the investigator, the participant is at high risk for symptomatic hyperviscosity syndrome.\n12. The participant has major surgery scheduled during the study, or the participant has not fully recovered from a recent major surgery (as judged by the investigator) during screening (participants with planned surgical procedures to be conducted under local anesthesia may participate).\n13. The participant has an active secondary (non-MM) malignancy or other medical condition with life-expectancy of less than (\\\u003C) 2 years.\n14. The participant has a known history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) after Intravenous Immunoglobulin (IVIG) and\u002For immune serum globulin infusions.\n15. The participant has a known history or current diagnosis of thromboembolic episodes such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, peripheral artery disease within 6 months before screening.\n16. The participant has moderate to severe renal dysfunction based on an estimated glomerular filtration rate less than (\\\u003C) 30 milliliters per minute per 1.73 square meters (mL\u002Fmin\u002F1.73 m\\^2), as defined by kidney disease: Improving Global Outcomes Clinical Practice Guideline for the Management of Glomerular Diseases, 2021 at the time of screening.\n17. The participant has a known history of or is positive at screening for one or more of the following: hepatitis B surface antigen, Polymerase Chain Reaction (PCR) for hepatitis C virus, PCR for Human Immunodeficiency Virus (HIV) Type 1 and Type 2. Cured participants with a history of hepatitis C infection who have a negative PCR test at screening are eligible.\n18. The participant has a documented diagnosis of a form of primary immunodeficiency (PID) involving a defect in antibody formation and requiring IgG replacement, as defined according to the International Union of Immunological Societies Committee.\n19. The participant has a persistent serum aspartate aminotransferase and alanine aminotransferase \\>3.0 times the upper limit of normal (ULN) at screening (may be repeated once to determine if it is persistent).\n20. The participant has an immunoglobulin A (IgA) deficiency (\\\u003C0.07 grams per liter \\[g\u002FL\\]) with antibodies to IgA and a history of hypersensitivity reaction to IVIG.\n21. Participant with a known systemic hypersensitivity to any of the excipients of IGI, 10% in accordance with the investigator's brochure\u002Fpackage insert\u002FSummary of Product Characteristics.\n22. Known substance abuse including opiates, psychostimulant agents, or other illicit drugs with the exception of cannabinoids within 12 months of screening.\n23. The participant has anemia that would preclude phlebotomy for laboratory studies, according to standard practice at the site, at the discretion of the investigator (may be repeated once to determine if it has resolved).\n24. The participant has a medical condition, laboratory finding, or physical examination finding that precludes participation or with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with the successful completion of the study or place the participant at undue medical risk.\n25. The participant is receiving immunosuppressive treatment (other than for MM or corticosteroids) at screening or plans to receive immunosuppressive treatment after study enrollment.\n26. The participant is not willing and able to comply with the protocol requirements.\n27. The participant has participated or is scheduled to participate in another clinical study involving an investigational product (IP) or investigational device within 30 days before screening and during the course of the study.\n28. The participant is a family member or employee of the investigator or the investigator's site staff.\n29. The participant is pregnant or has a positive pregnancy test or is lactating at the time of screening or enrollment.",{"count":405,"type":22},183,[26],"Multiple myeloma is a cancer of the plasma cells in the bone marrow.\n\nThe main aim of this study is to learn how well the Immune Globulin Infusion (human), 10 percentage (%) (IGI, 10%) can help prevent infections in participants with multiple myeloma receiving B-cell maturation antigen (BCMA) x cluster of differentiation 3 (CD3) directed bispecific antibody therapy.\n\nParticipants will be randomly assigned to one of two groups:\n\n1. Primary infection prevention group: They will receive IGI, 10% for 12 months.\n2. Secondary infection prevention group: They will only receive IGI, 10% if they develop a serious infection during the 12 months study period.\n\nDuring the study, participants will visit their study clinic 15 times (for 4-week dosing interval) or 19 times (for 3-week dosing interval) and their total participation duration will be up to 14 months (including screening period approximately 8 weeks).",[409,410],"Multiple Myeloma","Secondary Immunodeficiency",[33],"2026-08-06",{"date":368,"type":38},{"date":415,"type":38},"2026-01-14",{"date":417,"type":22},"2028-09-11",{"name":44,"class":45},{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":23,"phases":428,"briefSummary":429,"conditions":430,"keywords":431,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":375},"100571590","phase-3-a-study-of-mezagitamab-in-adults-with-chronic-primary-immune-thrombocytopenia-100571590","NCT06722235","A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia","A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Mezagitamab Subcutaneous Injection in Participants With Chronic Primary Immune Thrombocytopenia","Key Inclusion Criteria:\n\n1. The participant has been diagnosed with ITP that has persisted for at least 12 months.\n2. The participant's diagnosis of ITP is supported by a prior response to an ITP therapy (not including a thrombopoietin receptor agonist \\[TPO-RA\\]), defined as having achieved a platelet count ≥50,000\u002FμL.\n3. The participant has evidence of insufficient response or intolerance to at least 1 currently available first-line therapy for treatment of ITP (for example, corticosteroids), and at least 1 currently available second-line therapy for treatment of ITP (for example, TPO-RA, rituximab, fostamatinib, mycophenolate). Insufficient response to previous treatment is defined as failure to achieve a sustained platelet count of at least 50,000\u002FμL or doubling of baseline platelet count after an appropriate course of prior ITP treatment. Intolerance is defined as a documented side effect causing discontinuation of the therapy.\n4. The participant has a mean platelet count of less than (\\\u003C)30,000\u002FμL.\n5. If the participant is receiving allowed standard-of-care treatment for ITP at screening, and continued use is intended, treatment may continue during the trial if the dose, and frequency have been stable for at least 4 weeks before receiving the first dose of IMP (i.e., Day 1), and are expected to remain stable throughout the trial.\n6. If the participant is an individual with potential for pregnancy, the participant is not pregnant as confirmed by negative human chorionic gonadotropin during screening, and before the first dose of trial intervention.\n\nKey Exclusion Criteria:\n\n1. The participant has secondary ITP.\n2. The participant has had any thrombotic or embolic event within 12 months before signing the informed consent form (ICF).\n3. The participant has had a splenectomy.\n4. The participant has active infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).\n5. History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for treated non-melanoma skin cancer or cervical carcinoma in situ.\n6. In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.\n7. The participant has received anti-cluster of differentiation (CD) 20 treatment within 12 months before screening, and either of the following applies:\n\n   1. The last dose was received within 6 months before screening.\n   2. The last dose was received between 6 and 12 months before screening, and the participant has a cluster of differentiation 19 positive (CD19+) count below the lower limit of normal.\n8. The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before Day 1.\n9. The participant has any prior exposure to mezagitamab or has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Day 1.\n10. The participant has used anticoagulants (e.g., vitamin K antagonists, direct oral anticoagulants) within 3 weeks prior to the first dose of trial treatment.\n11. The participant has received a live or live-attenuated vaccine within 4 weeks prior to the first dose of trial treatment or has any live or live-attenuated vaccine planned during the trial.\n12. The participant has used the following immunosuppressive agents as specified prior to the first dose of trial treatment: alkylating agents (e.g., cyclophosphamide) within 8 weeks, vinca alkaloids (e.g., vincristine) within 4 weeks, sulfones (e.g., dapsone) within 3 weeks, antiproliferative agents: (e.g., mycophenolate mofetil, and azathioprine) within 2 weeks, and calcineurin inhibitors: (e.g., cyclosporine) within 2 weeks.\n13. The participant has used intravenous immunoglobulin (IVIg), SC immunoglobulin, recombinant human thrombopoietin, anti-D immunoglobulin treatment, or efgartigimod within 4 weeks before signing the ICF or it is expected that any treatment for thrombocytopenia other than the participant's standard-of-care ITP therapy (e.g., rescue therapy, administration of blood products) may be used between screening, and Day 1.\n14. The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab\u002Fplacebo formulation.\n\nOther protocol defined inclusion\u002Fexclusion criteria may apply.",{"count":427,"type":22},171,[26],"Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a low number of platelets, making it easier to bruise or bleed. The main aim of this study is to learn whether mezagitamab, when given just under the skin (subcutaneously \\[SC\\]), is effective in keeping the platelet count of adults with ITP stable when compared to a placebo. A placebo looks like medicine but doesn't have any active ingredients in it.\n\nThe participants will be treated with mezagitamab for up to 6 months.\n\nDuring the study, participants will visit their study clinic several times.\n\nParticipants who complete the TAK-079-3002 study or do not have any response to study treatment by week 16 (according to study criteria) will be given the opportunity to participate in a continuation study to receive open label mezagitamab (if they are eligible and the site is able to open the continuation study).",[268],[432,180,272,273,85,274,275,276,277,278,279,280,281],"Thrombocytopenia",{"date":368,"type":38},{"date":435,"type":38},"2025-02-27",{"date":437,"type":22},"2028-03-16",{"name":44,"class":45},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":247,"phases":4,"briefSummary":448,"conditions":449,"keywords":451,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":459},"100560455","a-survey-of-maribavir-tablets-in-participants-with-cytomegalovirus-infection-100560455","NCT06577363","A Survey of Maribavir Tablets in Participants With Cytomegalovirus Infection","Special Drug Use Surveillance of LIVTENCITY Tablets 200mg (All-Case Investigation)","Inclusion Criteria:\n\n\\- All participants with Cytomegalovirus (CMV) infection refractory to existing anti-CMV therapy in organ transplantation (including hematopoietic stem cell transplantation).\n\nExclusion Criteria:\n\n\\- None",{"count":447,"type":22},250,"This study is a survey in Japan of Maribavir tablets used to treat participants with Cytomegalovirus (CMV) infection refractory to existing anti-CMV therapy in organ transplantation (including hematopoietic stem cell transplantation).\n\nThe main aim of the study is to check if treatment with Maribavir can protect Japanese people against CMV infection, and to check side effect from the study treatment. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.\n\nDuring the study, participants with CMV infection will take Maribavir tablets according to their clinic's standard practice. The study doctors will check for side effects from Maribavir tablets for 27 weeks.",[450],"Cytomegalovirus (CMV)",[33],"2026-08-05",{"date":368,"type":38},{"date":455,"type":38},"2024-08-28",{"date":457,"type":22},"2028-06-30",{"name":44,"class":45},1,{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":247,"phases":4,"briefSummary":468,"conditions":469,"keywords":471,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":459},"100559511","a-database-survey-to-evaluate-the-safety-of-immune-globulin-subcutaneous-human-20-solution-in-participants-with-primary-immunodeficiency-100559511","NCT06565078","A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Primary Immunodeficiency","Post-marketing Database Survey: A Cohort Study to Evaluate the Safety of Cuvitru in Patients With Primary Immunodeficiency Using the PIDJ2 (Primary Immunodeficiency Database in Japan) Registry","Inclusion Criteria:\n\n1. Patients with primary immunodeficiency (PID) enrolled in the PID patient registry.\n2. Participant for whom study drug is entered in the therapeutic drug field on the data set.\n3. Participant who is entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.\n4. Participant for whom the presence or absence of adverse events has been entered in the column of adverse events.\n\nExclusion Criteria:\n\n1. Participant for whom study drug has not been entered in the drug name in the medical history field during the period from January 24, 2024 to January 23, 2029.\n2. Participant who is not entered the intractable disease diagnosis corresponding to PID in the intractable disease information field.\n3. Participant for whom the presence or absence of adverse events has not been entered in the column of adverse events.",{"count":339,"type":22},"This study is a retrospective database study in Japan to evaluate the safety of Immune Globulin Subcutaneous (Human), 20% Solution in participants with primary immunodeficiency disease (PID). This survey will conduct in use of medical database called PIDJ2.",[470],"Primary Immunodeficiency Diseases (PID)",[472],"Primary immunodeficiency disease",{"date":368,"type":38},{"date":475,"type":38},"2025-02-17",{"date":477,"type":22},"2030-03-31",{"name":44,"class":45},{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":247,"phases":4,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":490,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":459},"100551549","a-survey-of-susoctocog-alfa-genetical-recombination-in-participants-with-acquired-haemophilia-a-100551549","NCT06461533","A Survey of Susoctocog Alfa (Genetical Recombination) in Participants With Acquired Haemophilia A","General Use-results Survey of OBIZUR for I.V. Injection (All-case Surveillance)","Inclusion Criteria:\n\n\\- All participants with Acquired Haemophilia A, treated with Susoctocog Alfa (Genetical Recombination).\n\nExclusion Criteria:\n\n\\- None",{"count":7,"type":22},"This study is a survey in Japan of Susoctocog Alfa (Genetical Recombination) intravenous injection used to treat participants with bleeding events of acquired Haemophilia A (AHA). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.\n\nThe main aim of the study is to check for side effects related from Susoctocog Alfa (Genetical Recombination) intravenous injection and to check if Susoctocog Alfa (Genetical Recombination) intravenous injection improves bleeding events of AHA.\n\nDuring the study, participants with AHA will take Susoctocog Alfa (Genetical Recombination) intravenous injection according to their clinic's standard practice. The study doctors will check for side effects from Susoctocog Alfa (Genetical Recombination) intravenous injection for up to 90 days after the last dose of study drug or until discontinued (varied from participant to participant).",[489],"Acquired Hemophilia A",{"date":368,"type":38},{"date":492,"type":38},"2024-06-10",{"date":494,"type":22},"2028-05-31",{"name":44,"class":45},{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":23,"phases":505,"briefSummary":506,"conditions":507,"keywords":508,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":504},"100641830","phase-2-a-study-of-rusfertide-in-japanese-adults-with-polycythemia-vera-100641830","NCT07648030","A Study of Rusfertide in Japanese Adults With Polycythemia Vera","A Phase 2 Open-label Trial to Evaluate the Efficacy and Safety of Rusfertide in Japanese Patients With Polycythemia Vera","Inclusion Criteria:\n\n1. Japanese male and female participants aged 18 years or older at the time of signing informed consent.\n2. Participant understands the trial procedures, is willing and able to adhere to trial requirements and agrees to participate in the trial by giving written informed consent.\n3. Meet revised 2016 WHO criteria for the diagnosis of PV.\n4. Phlebotomy requiring defined as ALL of the following:\n\n   1. At least 3 phlebotomies due to inadequate hematocrit control in 28 weeks before trial intervention or at least 5 phlebotomies due to inadequate hematocrit control in 1 year before trial intervention, and\n   2. Last phlebotomy due to inadequate hematocrit control within 3 months before trial intervention, and\n   3. No phlebotomy within 6 days prior to trial intervention (do not include day of phlebotomy and day of trial intervention in the 6-day count).\n\n   Note: Phlebotomies performed within an 8-day period will be counted as a single phlebotomy.\n5. Hematology test values at screening:\n\n   1. Hematocrit \\\u003C45%\n   2. WBC 4,000\u002FµL to 20,000\u002FµL (inclusive), and\n   3. Platelets 100,000\u002FµL to 1,000,000\u002FµL (inclusive).\n6. ECOG performance status 0, 1 or 2.\n7. WOCBP agree to use at least 1 form of highly effective contraception during the trial and for 30 days after the last dose of trial intervention.\n8. A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial and for a period of 30 days after receiving the last dose of trial medication.\n9. A fertile man agree to use a condom, preferably combined with at least 1 form of acceptable contraception for any WOCBP partner(s) during the trial and for 90 days after the last dose of trial intervention.\n10. A male participant must agree not to donate sperm for the purpose of reproduction during the trial and for a minimum of 90 days after receiving the last dose.\n11. Participants receiving CRT at trial intervention must be on a stable PV therapy regimen as follows:\n\n    1. Hydroxyurea - at least 8 weeks\n    2. JAK inhibitor - at least 8 weeks\n    3. Interferon - at least 24 weeks. Note: A \"stable dose regimen\" of CRT does not mean an unchanged dose regimen. Temporary adjustments in dose regimen or temporary suspension of dosing are allowed. However, the total weekly dose of hydroxyurea and JAK inhibitor or total monthly dose of interferon may not be higher at trial intervention than the dose at the beginning of the pre-trial intervention observation period. The pre-trial intervention observation period is 8 weeks for hydroxyurea and JAK inhibitor and 24 weeks for interferon.\n12. Participants treated with phlebotomy alone at trial intervention must have stopped:\n\n    1. Hydroxyurea at least 8 weeks before trial intervention\n    2. JAK inhibitor at least 8 weeks before trial intervention\n    3. Interferon at least 24 weeks before trial intervention.\n\nExclusion Criteria:\n\n1. Clinically meaningful laboratory abnormalities at Screening including, but not limited to:\n\n   1. eGFR \\\u003C15 mL\u002Fmin\u002F1.73 m\\^2 as determined by Japanese Society of Nephrology. Calculated by the correction formula for Japanese\\*\n\n      \\*eGFR=194×(serum creatinine value)-1.094×(age)-0.287×(sex correction factor), Sex correction factor: 0.739 in female (Japanese Society of Nephrology,2023).\n   2. ALT or AST ≥2.5×ULN\n   3. Total bilirubin \\>1.5×ULN. Note: Screening laboratory tests with abnormal results (if considered by the investigator to be transient and inconsistent with the participant's clinical condition) may be repeated within the screening window to confirm abnormal results. If results return to protocol acceptable limits within the screening period, the participant may enter the trial. Use local labs for all eligibility lab tests.\n2. Participants who require phlebotomy at hematocrit levels lower than 45%.\n3. Pregnant females will be ineligible to participate in this trial if, despite a negative pregnancy test, the investigator determines that based on interview, clinical assessment, or other relevant information that the individual may be in the very early stages of pregnancy.\n4. Is capable of breastfeeding but does not agree to forego breastfeeding from the first dose of trial intervention through 30 days after the last dose of trial intervention.\n5. Clinically significant thrombosis (eg, deep vein thrombosis or splenic vein thrombosis) within 2 months prior to trial intervention.\n6. Active or chronic bleeding within 2 months prior to trial intervention.\n7. Meets the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT).\n8. Any infection requiring systemic therapy within 1 month of dosing except controlled: HIV, hepatitis B, and hepatitis C. Prophylactic therapies are allowed.\n9. Any serious or unstable medical condition (eg, poorly controlled HIV infection) or uncontrolled psychiatric condition as judged by the investigator that would impair the participant's ability to participate in the trial.\n10. Major surgical procedure within 2 months prior to trial intervention unless the participant has fully recovered from surgery or planned major elective surgery during the trial.\n11. History of invasive malignancies within the last 5 years, except\n\n    1. localized cured cancer (eg, prostate cancer and cervical cancer)\n    2. localized cured in situ or stage 1 squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or in situ melanoma of the skin.\n12. Participants with in situ or stage 1 squamous cell carcinoma of the skin, in situ or stage 1 basal cell carcinoma of the skin, or in situ melanoma of the skin identified during the required dermatology examination at screening unless the cancer is adequately treated (ie, treatment that is expected to be curative, such as Mohs surgery) before trial intervention. Note: Suspicious lesions should be biopsied and results available before trial intervention.\n13. Participants with active alcohol or drug addiction that would interfere with their ability to comply with trial requirements.\n14. Participants who do not complete at least 4 days of MFSAF v4.0 assessments within 1 week prior to trial intervention.\n15. Receipt of an investigational agent within 2 months or 5 half-lives, whichever is longer, prior to trial intervention.\n16. Received busulfan within 7 months prior to screening.\n17. Participants with hypersensitivity to rusfertide or to any of the excipients.\n18. Participants with any lesion or mass detected by physical examination or imaging during screening that is suspicious for malignancy unless evaluated and assessed to be not malignant.",{"count":504,"type":22},9,[25],"Polycythemia vera (PV) is a rare blood cancer in which the body makes too many red blood cells. This can make the blood thicker and may increase the risk of serious health problems such as blood clots. Many people with PV need regular phlebotomy, which is a procedure to remove blood, to help keep their hematocrit level under control. Hematocrit is the proportion of red blood cells in the blood.\n\nThe main aim of this study is to evaluate whether rusfertide helps Japanese participants with PV keep their hematocrit under control and avoid the need for phlebotomy. All participants in this study will receive rusfertide. This study is open-label, which means both the participants and the study team will know what treatment is being given.\n\nParticipants will be followed for up to about 244 weeks, including a screening period, a 52-week initial treatment period, a long-term extension period, and a 4-week safety follow-up period.",[301],[33],"2026-08-04",{"date":452,"type":38},{"date":512,"type":38},"2026-07-14",{"date":514,"type":22},"2030-05-17",{"name":44,"class":45},{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":23,"phases":526,"briefSummary":527,"conditions":528,"keywords":530,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":531,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":537},"100639449","phase-3-a-study-to-compare-elritercept-to-placebo-in-adults-with-myelofibrosis-and-anemia-who-are-taking-ruxolitinib-100639449","NCT07623161","A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib","A Phase 3, Double-Blind, Randomized Trial Evaluating the Efficacy and Safety of Elritercept (TAK-226) Compared to Placebo in Participants With Myelofibrosis and Anemia on Concurrent Ruxolitinib Therapy","ELRISE MF","Inclusion Criteria:\n\n1. Aged ≥18 years at the time of signing the informed consent form (ICF).\n2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF.\n3. Diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia (post-ET MF) or post-polycythemia vera (post-PV MF) according to the 2022 WHO criteria (WHO Classification of Tumours Editorial Board 2024), confirmed by local pathology report.\n4. Transfusion status as assessed in the 12 weeks immediately preceding randomization classified as Transfusion Dependent: 3 to 8 RBC units over 12 weeks.\n5. Receiving ruxolitinib (as approved in the country of the trial site) as the standard of care treatment for MF for at least 12 consecutive weeks, and on a stable daily dose for at least the 8 weeks immediately preceding the date of randomization.\n6. Eastern Cooperative Oncology Group score less than or equal to (≤) 2.\n\nExclusion Criteria:\n\n1. Prior treatment with luspatercept, sotatercept, or other transforming growth factor beta inhibitors or activin receptor ligand traps.\n2. Systemic treatment within 28 days before randomization with any of the following:\n\n   1. Androgens (including danazol). Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed.\n   2. erythropoiesis-stimulating agents.\n   3. granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor.\n   4. High dose corticosteroids. Participants on stable chronic steroid doses of prednisone ≤10 mg\u002Fday or corticosteroid equivalent for ≥4 weeks are allowed. Other treatments for autoimmune diseases may be allowed upon medical monitor review.\n   5. Hydroxyurea.\n   6. Immunomodulatory drugs (for example, thalidomide, pomalidomide, or lenalidomide).\n   7. Interferon.\n   8. Thrombopoietin receptor agonists.\n   9. Any investigational drug, including antihemojuvelin antibody. If the half-life of the investigational product is known, the exclusionary period prior to randomization is equal to 5 half-lives of the investigational product or 28 days, whichever is longer.\n3. Initiation of new iron chelation therapy or dose adjustments to existing iron chelation therapy ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed.\n4. Clinically significant anemia that is due to causes other than MF or Janus kinase (JAK) inhibitor therapy (for example, thalassemia, iron deficiency, vitamin B12 and\u002For folate deficiencies, autoimmune or hemolytic anemia, infections, or any active clinically significant bleeding or sequestration).\n5. Receipt of RBC transfusion for any reason(s) other than underlying MF within 12 weeks before randomization.\n6. Life expectancy \\\u003C12 months per investigator's judgment.\n7. Clinically significant cardiovascular disease, defined as:\n\n   1. New York Heart Association heart disease Class III or IV;\n   2. Fridericia corrected QT interval \\>500 millisecond (ms) during screening;\n   3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening.\n8. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimetres of mercury (mmHg) and\u002For diastolic blood pressure ≥100 mmHg despite adequate treatment.\n9. Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.\n10. Prior history of malignancies, other than MF. Participants who are free of other malignant disease for ≥2 years and have completed treatment, including maintenance, are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:\n\n    1. Basal or squamous cell carcinoma of the skin;\n    2. Carcinoma in situ of the cervix;\n    3. Carcinoma in situ of the breast; and\u002For\n    4. Incidental histologic finding of prostate cancer (T1a or T1b using the Tumour, Node, and Metastasis (TNM) staging system);\n    5. Early papillary thyroid cancer (stage I \\[T1-T2, N0, M0\\]).\n11. History of solid organ or bone marrow transplantation.\n12. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 7 days before randomization. Prophylactic antibiotics and\u002For antifungals for neutropenia are allowed.\n13. Known positivity for Human Immunodeficiency Virus (HIV), active hepatitis B virus (HBV), or active hepatitis C virus (HCV). Participants without known history of HIV, HBV, and\u002For HCV do not require further testing, unless testing is mandated per local guidelines.\n14. Body mass index ≥40 kilograms per square meter (kg\u002Fm\\^2).\n15. Major surgery within 28 days before randomization.\n16. History of allergy\u002Fanaphylaxis to recombinant proteins, investigational product, or excipients (refer to the current elritercept investigator's brochure for a list of excipients), or ruxolitinib.\n17. Any of the following local laboratory abnormalities:\n\n    1. Absolute neutrophil count \\\u003C500\u002Fmicroliter (μL) (0.5×109\u002F liter (L)).\n    2. Platelet count \\\u003C50,000\u002FμL (50×109\u002FL) or \\>1,000,000\u002FμL (1000×109\u002FL).\n    3. Blasts \\>5% as assessed in peripheral blood at screening or ≥10% in any historical bone marrow assessments. Participants with isolated transient elevations of peripheral blood blasts may be eligible after discussion between the investigator and medical monitor to confirm the blast count is not indicative of disease progression.\n    4. Serum aspartate aminotransferase or alanine aminotransferase ≥3× the upper limit of normal (ULN).\n    5. Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin less than (\\\u003C) 3×ULN are allowed. Higher levels if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis) may be allowed upon medical monitor review.\n    6. Estimated glomerular filtration rate \\\u003C30 milliliters per minute per 1.73 square meters (mL\u002Fmin\u002F1.73 m\\^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration equation.\n    7. Ferritin ≤50 micrograms per liter (μg\u002FL).\n    8. Folate ≤2.0 nanograms per milliliter (ng\u002FmL).\n    9. Vitamin B12 ≤200 picograms per milliliter (pg\u002FmL).\n18. Ongoing participation in another interventional clinical trial.\n19. Participant is unwilling or, in the opinion of the investigator, the participant is unable to comply with the requirements of the protocol.\n20. Is a person of childbearing potential but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of elritercept or placebo.\n21. Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom, during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.\n22. If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.\n23. For participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.",{"count":525,"type":22},324,[26],"The main aim of this study is to find out how well elritercept works to improve anemia in participants with myelofibrosis (MF) who are taking ruxolitinib when compared to placebo.\n\nOther aims are to learn how elritercept improves anemia compared to placebo; to learn if elritercept reduces tiredness, improves symptoms related to MF, and helps participants do physical activities more easily. The study also aims to find out how elritercept affects the bone marrow, the spleen, and whether participants develop antibodies to the study drug.\n\nThe study will also check how safe elritercept is compared to placebo, and if elritercept stays safe over a long period of time. Participants will receive study treatment for at least 9 months (36 weeks). After this period, participants who received placebo will have the option to switch to elritercept.",[529,61],"Myelofibrosis",[88,134],{"date":452,"type":38},{"date":533,"type":22},"2026-08-25",{"date":535,"type":22},"2034-03-30",{"name":44,"class":45},194,{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":545,"targetDuration":4,"studyType":247,"phases":4,"briefSummary":547,"conditions":548,"keywords":550,"overallStatus":230,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":551,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":4},"100626000","a-study-to-learn-more-about-the-treatment-of-people-with-congenital-thrombotic-thrombocytopenic-purpura-cttp-who-received-recombinant-adamts13-radamts13-as-part-of-the-early-access-program-100626000","NCT07429942","A Study to Learn More About the Treatment of People With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Who Received Recombinant ADAMTS13 (rADAMTS13) as Part of the Early Access Program","Treatment and Management of Patients With Congenital Thrombotic Thrombocytopenic Purpura (cTTP): An International, Multi-center Retrospective Chart Review of Patients in the Early Access Program (EAP) Treated With Recombinant ADAMTS13 (rADAMTS13)","Inclusion criteria for the rADAMTS13 EAP are:\n\n* Participants of any age can participate who have a confirmed diagnosis of severe congenital ADAMTS13 deficiency or cTTP.\n* Participants must be on preventative or prophylactic treatment for cTTP or must have had at least one TTP event in the past.\n* Participants must have no other treatment options available (this includes other clinical studies for cTTP).\n\nThe inclusion criteria for this retrospective chart review are:\n\n* Pediatric and adult participants (no age restrictions) with cTTP, treated with rADAMTS13 via the EAP, who received at least two administrations of rADAMTS13 and who have provided consent (or the legal guardians) to participate in this retrospective chart review.\n* As per local regulations, evidence of a personally signed (or signed by a legally acceptable representative) and dated informed consent form\u002Finformed assent form (ICF\u002FIAF) indicating that the participant (or their legal guardian) has been informed of all pertinent aspects of the retrospective chart review or an approval to process data without informed consent granted by an institutional review board\u002Findependent ethics committee (IRB\u002FIEC)) Participants included in the EAP who were\u002Fare transitioned to the commercially available product will have their data abstracted for the duration of their participation in the EAP as well as when they received the commercially available product until the end of chart abstraction.\n\nThere are no additional exclusion criteria for this chart review.",{"count":546,"type":22},94,"Congenital thrombotic thrombocytopenic purpura (cTTP) is a rare blood disorder that some people are born with. It is caused by inherited changes in the ADAMTS13 gene that reduce the body's ability to produce the ADAMTS13 enzyme. ADAMTS13 normally cleaves ultra-large multimers of a protein called von Willebrand factor (VWF). In cTTP, low ADAMTS13 activity allows these ultra-large VWF multimers to build up and promote blood clot formation in small blood vessels. These clots can restrict blood flow to vital organs and lead to serious complications.\n\nRecombinant ADAMTS13 (rADAMTS13) is a manufactured form of human ADAMTS13 designed to replace the missing enzyme and restore ADAMTS13 activity.\n\nThis study aims to describe the impact of cTTP on participants before and after treatment with rADAMTS13. It will also evaluate participants' health outcomes after treatment and describe treatment patterns before and after rADAMTS13, including whether treatment was used to prevent or treat TTP episodes, how often it was given, the amount received, and others. In addition, the study will describe pregnancies and outcomes for the mother and baby before and during treatment with rADAMTS13.\n\nOnly data already available in the medical records of the people who received rADAMTS13 through Takeda's early access program (EAP) for cTTP will be collected and reviewed in this study.",[549],"Thrombotic Thrombocytopenic Purpura (TTP)",[33],{"date":368,"type":38},{"date":553,"type":22},"2026-08-31",{"date":555,"type":22},"2026-10-30",{"name":44,"class":45},{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":564,"targetDuration":4,"studyType":23,"phases":566,"briefSummary":567,"conditions":568,"keywords":569,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":576},"100617532","phase-2-a-study-of-tak-226-for-anemia-in-japanese-patients-with-lower-risk-myelodysplastic-syndromes-100617532","NCT07319845","A Study of TAK-226 for Anemia in Japanese Patients With Lower-Risk Myelodysplastic Syndromes","A Phase 2, Multicenter, Open-Label, Single-arm Study to Evaluate the Efficacy and Safety of TAK-226 for Anemia in Japanese Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes","Inclusion Criteria:\n\n1. Participants or their legally authorized representative must be willing and able to sign the ICF and to adhere to the protocol requirements.\n2. Japanese adult male or female participant \\>=18 years of age at the time of signing informed consent.\n3. Diagnosis of MDS with or without ring sideroblasts (RS) (as determined in an evaluable bone marrow aspirate collected at Screening to confirm diagnosis) according to WHO 2016 classification that meets the International Prognostic Scoring System-Revised (IPSS-R) classification of very low-, low-, or intermediate-risk MDS.\n\n   Note: Due to expected impacts of transfusion, hemoglobin (Hgb) values from blood samples collected within 14 days following a RBC transfusion and platelet count obtained within 7 days following a platelet transfusion cannot be used to evaluate IPSS-R for eligibility.\n4. TD\\[YY1.1\\] cohort: Transfusion dependence assessed in the 16 weeks immediately preceding enrollment in two 8-week blocks classified as either:\n\n   1. Low-transfusion burden (LTB), defined as 4 to 7 RBC units per 16 weeks; or\n   2. HTB\\[YY2.1\\], defined as \\>=8 RBC units per 16 weeks; and\n   3. For all participants: i. Only transfusion events for a pretransfusion Hgb \\\u003C10 g\u002FdL are counted toward eligibility; ii. At least 1 transfusion event in each 8-week block and a minimum of 2 transfusion events separated by \\>=7 days within the 16-week period immediately preceding enrollment; and iii. No consecutive 56-day period can be RBC transfusion-free during the 16 week period immediately preceding enrollment.\n\n   Note: Only transfusions for the disease under study will be counted towards classification for LTB or HTB participants. Transfusions for intercurrent diseases (bleeding, surgical procedure, infection, etc.) are not considered.\n\n   NTD\\[YY3.1\\] cohort: NTD, defined as 0 to 1 RBC units per 8 weeks immediately preceding enrollment.\n\n   Note: RBC transfusions administered when Hgb levels were \\\u003C9.0 g\u002FdL are counted for eligibility. RBC transfusions administered for other than MDS-related anemia (bleeding, surgical procedure, infection, etc.) will not be counted as a required transfusion for the purpose of meeting eligibility criteria.\n5. TD cohort: Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued \\>=4 weeks before enrollment), or unlikely to respond to ESA treatment, defined as follows:\n\n   a. Refractory to prior ESA treatment: documentation of nonresponse or a response that was no longer maintained with a prior ESA-containing regimen, either as a single agent or combination (eg, with granulocyte colony-stimulating factor \\[G-CSF\\]); ESA regimen must have been either: i. Recombinant human erythropoietin (EPO) \\>=40,000 IU\u002Fweek for \\>=8 doses or equivalent; or ii. Darbepoetin alpha \\>=500 mcrg every 3 weeks for \\>=4 doses or equivalent. b. Intolerant to prior ESA treatment: documentation of discontinuation of a prior ESA containing regimen, either as a single agent or combination (eg, with G-CSF), at any time after introduction due to intolerance or an AE.\n\n   c. Unlikely to respond to ESA treatment: low chance of response to ESA based on an endogenous serum EPO level \\>200 U\u002FL.\n\n   Note: Due to expected impacts of transfusion on EPO levels, blood samples collected within the 14 days following an RBC transfusion or within 7 days following a platelet transfusion cannot be used to evaluate serum EPO level for eligibility.\n\n   NTD cohort: Hgb \\\u003C10 g\u002FdL and exhibiting anemia-related clinical symptoms (eg, fatigue, shortness of breath, or others) during screening.\n6. Less than 5% blasts in an evaluable bone marrow aspirate collected at Screening.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n8. Women of childbearing potential (WOCBP), defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months must\n\n   1. Agree to use 1 highly effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 60 days after the last dose of study drug; or\n   2. Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \\[eg, calendar, ovulation, symptothermal, postovulation methods\\], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.)\n9. Male participants must, even if he is surgically sterilized (ie, status postvasectomy),\n\n   1. Agree to practice effective barrier contraception the time of signing the informed consent through 60 days after the last dose of study drug; or\n   2. Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \\[eg, calendar, ovulation, symptothermal, postovulation methods\\], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.)\n\nExclusion Criteria:\n\nMedical History\n\n1. Del(5q) MDS or therapy-related (secondary) MDS.\n2. Anemia due to any other known cause (eg, thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and\u002For folate).\n3. Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks in TD cohort or 8 weeks in NTD cohort before enrollment.\n4. Clinically significant cardiovascular disease defined as:\n\n   1. New York Heart Association heart disease class III or IV;\n   2. Fridericia corrected QT (QTcF) interval \\>500 milliseconds during Screening;\n   3. Presence of uncontrolled hypertension defined as mean systolic blood pressure \\>=160 mm Hg or diastolic blood pressure \\>=100 mm Hg during Screening; or\n   4. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before Screening.\n5. Known ejection fraction \\\u003C35%, confirmed by a local echocardiogram performed during Screening, or a previously performed echocardiogram if collected within 6 months before Screening.\n6. Stroke, deep vein thrombosis, or pulmonary embolism within 6 months before Screening.\n7. Any known history of acute myeloid leukemia (AML).\n8. Prior history of malignancies, other than MDS, unless the participant has been free of the disease (including completion of any treatment, including maintenance, for prior malignancy) for \\>=5 years. However, participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:\n\n   1. Basal or squamous cell carcinoma of the skin;\n   2. Carcinoma in situ of the cervix;\n   3. Carcinoma in situ of the breast; and\u002For\n   4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis \\[TNM\\] clinical staging system).\n9. History of solid organ or bone marrow transplantation.\n10. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 14 days before enrollment.\n11. History of or known active or chronic infection with HIV, active infectious hepatitis B virus (HBV), or active infectious hepatitis C virus (HCV). Participants who are positive for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis B surface antibody (HBsAb) may be eligible for enrollment if their hepatitis B viral load is below the limit of detection. Participants who are positive for hepatitis C virus antibodies (HCVAb) may be enrolled if their hepatitis C viral load is below the limit of detection.\n12. Body mass index \\>=40 kg\u002Fm\\^2.\n13. Major surgery within 28 days before enrollment.\n14. History of allergy\u002Fanaphylaxis to investigational medicinal product (IMP) excipients (refer to the current elritercept \\[TAK 226\\] IB for a list of excipients) or recombinant proteins.\n\n    Treatment History\n15. TD cohort: Prior use of TAK 226, luspatercept, imetelstat, or sotatercept. \\[YY4.1\\] NTD cohort: Prior use of TAK 226, luspatercept, imetelstat, sotatercept, or ESAs.\n\n    Note for NTD cohort: At the investigator's discretion in consultation with the medical monitor, may be allowed if received no more than 2 doses of ESAs \\>=8 weeks prior to enrollment.\n16. Prior use of hypomethylating agents (HMAs), isocitrate dehydrogenase inhibitor, lenalidomide, or immunosuppressive therapy given for treatment of MDS.\n17. Iron chelation therapy initiated within 8 weeks before enrollment. Participants on stable doses of iron chelation therapy for \\>=8 weeks are allowed.\n18. Vitamin B12 or folate therapy initiated within 4 weeks before enrollment. Participants on stable replacement doses for \\>=4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.\n19. Androgen use within 8 weeks before enrollment. Participants on stable androgen dosing for hypogonadism for \\>=8 weeks are allowed.\n20. High-dose corticosteroid use within 4 weeks before enrollment. Participants on stable chronic steroid doses of prednisone\u002Fprednisolone \\\u003C=10 mg\u002Fday or corticosteroid equivalent for \\>=4 weeks are allowed.\n21. Treatment with any investigational drug within 28 days before Screening or, if the half-life of the product is known, within 5 times the half-life before Screening, whichever is longer.\n22. Ongoing participation in another interventional clinical study. Laboratory Exclusions (during Screening)\n23. Serum EPO level \\>500 U\u002FL. Note: Due to expected impacts of transfusion on EPO levels, laboratory results from blood samples collected within the 14 days following an RBC transfusion cannot be used to evaluate serum EPO level for eligibility.\n24. Platelet count \\>=450\\*10\\^3\u002FmcrL or \\\u003C=25\\*10\\^3\u002FmcrL. Note: Due to expected impacts of transfusion, laboratory results from blood samples collected within the 7 days following a platelet transfusion cannot be used to evaluate platelet count for eligibility.\n25. Absolute neutrophil count \\\u003C=500\u002FmcrL\n26. Serum AST or ALT \\>=3\\*the upper limit of normal (ULN).\n27. Total bilirubin \\>=2\\*ULN unless attributable to Gilbert syndrome.\n28. Ferritin \\\u003C=50 mcrg\u002FL.\n29. Folate \\\u003C=2.0 ng\u002FmL.\n30. Vitamin B12 \\\u003C=200 pg\u002FmL.\n31. Estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m\\^2 as determined by Japanese Society of Nephrology. Calculated by the correction formula for Japanese. a)\n\n    a) eGFR=194\\* (serum creatinine value)\\^-1.094\\* (age)\\^-0.287\\* (sex correction factor), Sex correction factor: 0.739 in female.\n\n    Miscellaneous\n32. Pregnant or lactating female\\[YY5.1\\]. Note: Participants who may be in the very early stage of pregnancy based on the doctor's interview with a negative pregnancy test are excluded from the study. Participants who are lactating will be eligible if they discontinue breastfeeding from before the first dose of study drug until 60 days after the last dose of study drug.\n33. Any other condition not specifically noted above that, in the opinion of the investigator, would preclude the participant from participating in the study or could confound interpretation of data from the study.\n34. Investigational site staff members directly involved in the conduct of the study and site staff members otherwise supervised by the investigator, employees of the Sponsor or contract research organization (CRO) directly involved in the conduct of the study, or immediate family members (defined as a spouse, parent, child, or sibling, whether biological or legally adopted).",{"count":565,"type":22},42,[25],"The main aim of the study is to evaluate how TAK-226 improves symptoms of transfusion-dependent anemia in Japanese patients with lower-risk myelodysplastic syndromes.\n\nThe study consists of Screening Period (up to 6 weeks), Treatment Period, Safety Follow-Up Period (8 weeks), and Long-Term Follow-Up Period (5 years from the first dose of the study drug or 3 years after the last dose, whichever is longer).\n\nParticipants of this study will be administered TAK-226 during Treatment Period. Subsequently, the participants will be monitored for side effects related to the study treatment during Safety Follow-Up Period and Long-Term Follow-Up Period. The approximate duration of participation for a participant is up to approximately 6 years.\n\nDuring the study period, participants will visit the study clinic\u002Fhospital multiple times as per the study schedule. During Treatment Period, the participants will come to the clinic\u002Fhospital approximately every two to four weeks.",[59],[33],{"date":452,"type":38},{"date":572,"type":38},"2026-04-22",{"date":574,"type":22},"2033-01-10",{"name":44,"class":45},20,""]