[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Novartis Pharmaceuticals\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":730},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,228,0,25,[9,50,79,108,137,169,199,229,256,286,311,335,360,387,422,449,474,504,529,555,587,613,642,673,708],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100625325","phase-2-a-study-to-assess-the-tolerability-of-ianalumab-vay736-with-investigators-choice-thrombopoietin-receptor-agonist-ic-tpo-ra-in-patients-with-primary-immune-thrombocytopenia-itp-100625325",false,"NCT07421167","A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)","A Phase 2 Open-label Study to Evaluate the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least One Treatment (VAY2EXPLORE)","VAY2EXPLORE","Key Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Patients aged 18 years and older on the day of signing the informed consent.\n* ITP cohort only: Confirmed diagnosis of primary ITP that has previously responded to corticosteroid treatment or IVIG treatment but the response was not sustained (response is defined as a platelet count ≥ 50 G\u002FL).\n* ITP cohort only: Received at least one prior treatment for ITP.\n* ITP cohort only: Patients with a platelet count \\\u003C 100 G\u002FL who are receiving a TPO-RA. Patients may already be receiving a TPO-RA or may start a TPO-RA at the time of screening. All patients should be on a stable dose of TPO-RA for at least 14 days prior to first dose of ianalumab. Note: during the screening period, a documented assessment of platelets \\\u003C 100 G\u002FL is mandatory for enrollment. For patients who received rescue medication before screening, platelet count results obtained prior to the start of the rescue therapy should be used to assess eligibility if collected within 14 days prior to screening.\n* ES cohort only: Patients with clinical diagnosis of primary ES with active thrombocytopenia (\\\u003C 100 G\u002FL) with warm autoimmune hemolytic anemia (wAIHA) for whom a TPO-RA is appropriate per Investigator.\n* ES cohort only: Inadequate response to or relapse after treatment with corticosteroid therapy.\n* ES cohort only: Diagnosis confirmed by current or past positive direct antiglobulin test (DAT) (IgG+, with or without C3+) and evidence of hemolysis.\n* ES cohort only: any supportive care treatment administered for wAIHA must be stable for at least 4 weeks prior to enrollment.\n\nKey Exclusion Criteria:\n\n* Patients being treated with TPO-RA for \\> 6 months.\n* Current life-threatening bleeding (related to thrombocytopenia).\n* Prior splenectomy within 6 months of first administration of ianalumab.\n* Patients with the following laboratory abnormalities:\n\n  * Neutrophils: \\\u003C 1000\u002Fmm3\n  * Serum creatinine \\> 1.5 × upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST) \\> 3.0 × ULN\n  * Alanine aminotransferase (ALT) \\> 3.0 × ULN\n  * Immunoglobulin G (IgG) \\\u003C 5 g\u002FL\n  * ITP cohort only: hemoglobin \\\u003C 10 g\u002FL, total bilirubin \\> 1.5 × ULN\n* Patients with significantly compromised liver disease (Child-Pugh 7 to 9) and decompensated liver disease (Child-Pugh 10 to 15).\n* Treatment with a B-cell depleting therapy (e.g. rituximab or anti-B cell Activating Factor (e.g. belimumab) within 12 weeks prior to the first administration of ianalumab. Patients who are refractory to rituximab will be excluded from this trial, where refractory is defined as:\n\n  \\~ Patients who have not achieved a response (defined as platelet count ≥ 30 G\u002FL and at least doubling from baseline within 12 weeks in the absence of rescue therapy) following completion of a standard course of rituximab\n* History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes.\n* Known history of primary or secondary immunodeficiency, or a positive human immunodeficiency virus (HIV) enzyme-linked immunosorbent assay (ELISA) and Western blot) test result.\n* Patients exposed to more than 4 prior treatments for ITP.\n* ITP cohort only: Diagnosis of secondary thrombocytopenia.\n* ITP cohort: Use of immunosuppressant drugs other than corticosteroids or rituximab.\n* ES cohort only: Diagnosis of secondary ES.\n* ES cohort only: Life-threatening hemolysis.\n* ES cohort only: patients with autoimmune hemolytic anemia other than wAIHA","ALL","18 Years",{"count":21,"type":22},164,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The purpose of this study is to investigate the tolerability of ianalumab (9 mg\u002Fkg) with investigator's choice thrombopoietin receptor agonist (IC TPO-RA) in participants diagnosed with primary immune thrombocytopenia (ITP) who have been treated with at least one but no more than four prior treatments, and with no change in IC TPO-RA dose in at least the last 14 days prior to the start of ianalumab.",[28,29],"Primary Immune Thrombocytopenia (ITP)","Primary Evans Syndrome (ES)",[31,32,33,34,35,36],"Immune thrombocytopenia (ITP)","Evans syndrome (ES)","Ianalumab","VAY736","B-cell depletion","B-cell Activating Factor Receptor (BAFF-R)","RECRUITING","2026-08-20",{"date":40,"type":41},"2026-08-21","ACTUAL",{"date":43,"type":41},"2026-08-04",{"date":45,"type":22},"2030-09-13",{"name":47,"class":48},"Novartis Pharmaceuticals","INDUSTRY",10,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100620446","phase-3-a-phase-3-study-of-pelabresib-dak539-and-ruxolitinib-in-myelofibrosis-mf-100620446","NCT07357727","A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)","A Phase 3, Randomized, Double-blind, Active-control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients With Myelofibrosis Who Are JAK Inhibitor Naive","MANIFEST-3","Key Inclusion Criteria:\n\n* Participants have diagnosis of primary myelofibrosis (PMF) or post-polycythemia vera myelofibrosis (post-PV MF) or post-essential thrombocythemia myelofibrosis (post-ET MF) according to the International Consensus Classification (ICC) of Myeloid Neoplasms and Acute Leukemias 2022\n* DIPSS risk category of intermediate-1, intermediate-2 or high-risk\n* Spleen volume ≥ 450 cm3 by CT or MRI scan (local read sufficient if no central read available)\n* Have an average TSS of ≥15 within 7 days prior to randomization, using MFSAF v. 4.0 (at least 4 out of 7 TSS assessments required for average calculation)\n* Participants with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2\n* Blasts \\\u003C5% in peripheral blood. Assessment of blasts in peripheral blood is mandatory at screening\n* Platelet count ≥ 100 x 10\\^9\u002FL in the absence of growth factors or transfusions for the previous 4 weeks\n\nKey Exclusion Criteria:\n\n* Prior splenectomy at any time or splenic irradiation in the previous 6 months\n* Prior hematopoietic cell transplant or participant anticipated to receive a hematopoietic cell transplant within 24 weeks from the date of randomization\n* Blasts ≥ 5% in bone marrow if results available at screening or history of accelerated phase (AP) or leukemic transformation\n* History of a malignancy (other than MF, PPV-MF or PET-MF) in the past 3 years in need of systemic treatment\n* Received any approved or investigational agent other than hydroxyurea or anagrelide for the treatment of MF within 14 days of first dose of study treatment or within 5 half-lives of the approved or investigational agent, whichever is longer\n* Prior treatment with any JAK inhibitor or Bromodomain and extraterminal domain (BET) inhibitor\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":59,"type":22},460,[61],"PHASE3","The purpose of this trial is to evaluate whether treatment with pelabresib in combination with ruxolitinib leads to improved clinical outcomes compared to ruxolitinib alone in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) who have not previously received Janus kinase (JAK) inhibitor therapy.",[64,65,66],"Primary Myelofibrosis (PMF)","Post-polycythemia Vera Myelofibrosis (PPV-MF)","Post-essential Thrombocythemia Myelofibrosis (PET-MF)",[68,69,70,71],"Pelabresib (DAK539)","Ruxolitinib","Adult participants","Myelofibrosis (MF)",{"date":40,"type":41},{"date":74,"type":41},"2026-06-16",{"date":76,"type":22},"2030-12-27",{"name":47,"class":48},49,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":87,"minAge":19,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100608784","phase-1-an-open-label-dose-escalation-and-expansion-followed-by-a-phase-ii-study-of-tulmimetostat-dzr123-and-jsb462-luxdegalutamide-in-patients-with-progressive-metastatic-castrate-resistant-prostate-cancer-mcrpc-tulmistar-01-100608784","NCT07206056","An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (mCRPC) (TulmiSTAR-01)","TulmiSTAR-01: A Two-part, Phase I Dose Escalation and Expansion Followed by a Randomized, Open-label Multicenter, Phase II Study to Assess the Safety and Efficacy of the Combination of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) vs Standard of Care in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer","TulmiSTAR-01","Key Inclusion Criteria:\n\n* Participant is an adult man ≥ 18 years of age.\n* Participant must have histologically and\u002For cytologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell features (current or prior biopsy of the prostate and\u002For metastatic site).\n* Participant must have ≥ 1 metastatic lesion that is present on screening\u002Fbaseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to start of treatment (Part 1a dose escalation) or randomization (Part 1b dose expansion and Part 2).\n* Participant must have progressive mCRPC.\n* Participant must have a castrate level of serum\u002Fplasma testosterone (\\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL).\n* Prior ARPI therapy:\n\n  * Part 1a and 1b only: must have progressed on at least one prior second generation ARPI (abiraterone, enzalutamide, darolutamide, or apalutamide).\n  * Part 2 only: must have progressed on one prior second generation ARPI (abiraterone, enzalutamide, darolutamide, or apalutamide).\n* Prior chemotherapy:\n\n  * Part 1a dose escalation only: may have received ≤ 2 prior lines of chemotherapy in CRPC setting. Note: Prior chemotherapy is permitted in the HSPC setting.\n  * Part 1b dose expansion\u002Foptimization only: may have received up to one prior line of chemotherapy in CRPC setting. Note: Prior chemotherapy is permitted in the HSPC setting.\n  * Part 2 only: Participants must be taxane-naïve in mCRPC setting; prior chemotherapy permitted in HSPC setting only\n\nKey Exclusion Criteria:\n\n* Previous treatment with any PRC2 inhibitor, including but not limited to EZH2 inhibitors, EZH2\u002F1 inhibitors, or embryonic ectoderm development (EED) inhibitors.\n* Previous treatment with a protein degrader compound that targets the AR.\n* Known hypersensitivity or contraindication to any of the study treatment components or its excipients or to drugs of similar chemical classes.\n* Treatment with any investigational agent within 28 days (or 5 half-lives, whichever is longer) prior to study entry.\n* Previous treatment with radioligand therapy in the mCRPC setting, except in Part 1a where participants may have received RLT in mCRPC setting.\n* Participants with evidence of mCRPC or biochemical recurrence \u002F PSA only disease or asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy and with normal PSA for ≥ 1 year prior to study entry.\n* Participants with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purpose of maintaining neurologic integrity. Those with leptomeningeal disease are eligible if those areas have been treated, are stable, and no neurological impairment is present. For those with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain with MRI (preferred) or CT with contrast.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","MALE",{"count":89,"type":22},188,[91,25],"PHASE1","This is a two-part, Phase I\u002FII, open-label, global, multicenter study assessing the safety and efficacy of the combination of tulmimetostat (DZR123) and JSB462 (luxdegalutamide) versus standard of care in participants with progressive metastatic castrate resistant prostate cancer (mCRPC).",[94],"Progressive Metastatic Castrate Resistant Prostate Cancer",[96,97,98,99,100,85],"metastatic castrate resistant prostate cancer (mCRPC)","tulmimetostat (DZR123)","luxdegalutamide (JSB462)","Androgen Deprivation Therapy (ADT)","Standard of care (SoC)",{"date":40,"type":41},{"date":103,"type":41},"2025-10-15",{"date":105,"type":22},"2030-12-01",{"name":47,"class":48},35,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":18,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},"100573819","phase-1-study-to-evaluate-the-pharmacokinetics-pk-safety-and-tolerability-up-to-6-years-of-intravenous-iv-secukinumab-in-pediatric-participants-with-juvenile-psoriatic-arthritis-jpsa-100573819","NCT06751238","Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability up to 6 Years of Intravenous (i.v.) Secukinumab in Pediatric Participants With Juvenile Psoriatic Arthritis (JPsA).","An Open-label, Multicenter Study to Evaluate Pharmacokinetics, Safety and Tolerability up to 6 Years of Intravenous Secukinumab Infusions in Pediatric Participants With Juvenile Psoriatic Arthritis","Key Inclusion Criteria:\n\n* Participants parent's or legal representative(s) written informed consent and child's assent, if appropriate, must be obtained before any study related activity or assessment is performed. Of note, if the participant reaches age of consent (as per local law) during the study, they will also need to sign the corresponding study ICF (Informed Consent Form).\n* Males and females ≥2 years old to \\\u003C18 years old at the time of screening.\n* Confirmed diagnosis of JPsA according to the modified International League of Associations for Rheumatology (ILAR) classification criteria that must have occurred at least 6 months prior to screening.\n* Active JPsA disease defined as ≥3 active joints (swollen or if not swollen must be both tender and limited range of motion) at baseline (BSL).\n* Inadequate response (≥1 month) or intolerance to ≥1 Non-Steroidal Anti-Inflammatory Drug (NSAID) at screening.\n* Inadequate response (≥2 months) or intolerance to ≥ 1 Disease Modifying Anti-Rheumatic Drug (DMARD) at screening.\n* Concomitant use of the following second-line agents such as disease-modifying and\u002For immunosuppressive drugs to treat the JPsA will be allowed:\n\n  * Stable dose of methotrexate (MTX) (maximum of 20 mg\u002F m2 BSA\u002F week) for at least 4 weeks prior to the BSL visit, with folic\u002Ffolinic acid supplementation (according to standard medical practice of the center).\n  * Stable dose of an oral corticosteroid (CS) at a prednisone equivalent dose of \\\u003C0.2 mg\u002Fkg\u002Fday or up to 10 mg\u002Fday maximum, whichever is less, for at least 7 days prior to BSL.\n  * Stable dose of no more than one NSAID for at least 1 week prior to BSL.\n\nKey Exclusion Criteria:\n\n* Participants with body weight less than 10 kg at screening.\n* Use of other investigational drugs within 4 weeks or 5 half-lives of BSL, or until the expected pharmacodynamic effect has returned to BSL, whichever is longer.\n* History of hypersensitivity to study drug or its excipients or to drugs of similar chemical classes.\n* Participants with active inflammatory bowel disease or active uveitis at screening or BSL.\n* Fulfilling diagnostic criteria for any International League of Associations for Rheumatology (ILAR ) juvenile idiopathic arthritis (JIA) category other than JPsA at BSL.\n* Participants treated with prohibited medication\n* Participants taking any non-biologic DMARD at screening except for MTX.\n* Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.\n\nOther inclusion\u002Fexclusion criteria may apply","2 Years","17 Years",{"count":118,"type":22},20,[91],"The purpose of this study is to determine the PK, safety and tolerability of multiple doses of intravenous (i.v.) secukinumab in pediatric participants with JPsA",[122],"Juvenile Psoriatic Arthritis",[124,125,126,127,128,129],"Pediatric","JPsA","Pharmacokinetic (PK)","safety","Intravenous (i.v.)","Secukinumab",{"date":40,"type":41},{"date":132,"type":41},"2025-09-24",{"date":134,"type":22},"2031-03-11",{"name":47,"class":48},11,{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":18,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":23,"phases":148,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},"100551621","phase-4-study-of-efficacy-and-safety-of-ruxolitinib-in-patients-with-grade-ii-to-iv-steroid-refractory-acute-graft-vs-host-disease-100551621","NCT06462469","Study of Efficacy and Safety of Ruxolitinib in Patients With Grade II to IV Steroid-refractory Acute Graft vs. Host Disease","A Single-arm, Multi-center Study of Ruxolitinib for the Treatment of Chinese Patients With Grade II-IV Corticosteroid-refractory Acute Graft Versus Host Disease","Key Inclusion criteria\n\n* Male or female Chinese participants aged 12 or older at the time of informed consent. Written informed consent from participant, parent or legal guardian.\n* Able to swallow tablets.\n* Have undergone alloSCT from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood.\n* Clinically diagnosed Grades II to IV acute GvHD as per standard criteria occurring after alloSCT requiring systemic immune suppressive therapy.\n* Evident myeloid and platelet engraftment (confirmed within 48 hours prior to study treatment (ruxolitinib) start):\n* Confirmed diagnosis of steroid refractory aGvHD defined as participants administered systemic corticosteroids (methylprednisolone at least 1 mg\u002Fkg\u002Fday \\[or equivalent prednisone dose at least 1.25 mg\u002Fkg\u002Fday\\]), given alone or combined with calcineurin inhibitors (CNI) and either:\n\n  1. Progression based on organ assessment after at least 3 days compared to organ stage at the time of initiation of systemic corticosteroid +\u002F- CNI for the treatment of Grade II to IV aGvHD. OR\n  2. Failure to achieve at a minimum partial response based on organ assessment after 7 days compared to organ stage at the time of initiation of systemic corticosteroid +\u002F-CNI for the treatment of Grade II to IV. OR\n  3. Participants who fail corticosteroid taper defined as fulfilling either one of the following criteria:\n\n     * Requirement for an increase in the corticosteroid dose to methylprednisolone ≥ 1 mg\u002Fkg\u002Fday (or equivalent prednisone dose ≥ 1.25 mg\u002Fkg\u002Fday). OR\n     * Failure to taper the methylprednisolone dose to \\\u003C 0.5 mg\u002Fkg\u002Fday (or equivalent prednisone dose \\\u003C0.6 mg\u002Fkg\u002Fday) for a minimum of 7 days.\n\nKey Exclusion criteria\n\n* Has received more than one systemic treatment for steroid refractory aGvHD. Participants who received JAK inhibitor therapy for any indication after initiation of current alloSCT conditioning.\n* Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome with both acute and chronic GvHD features.\n* Failed prior alloSCT within the past 6 months. Presence of relapsed primary malignancy after the alloSCT was performed.\n* Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment.\n* SR-aGvHD occurring after non-scheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence. Note: Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible.\n* Presence of significant respiratory disease, severely impaired renal function, clinically significant or uncontrolled cardiac disease, unresolved cholestatic and liver disorders (not attributable to aGvHD). Disorders and\u002For current therapy with medications that interfere with coagulation or platelet function.\n\nOther protocol-defined inclusion \u002F exclusion criteria may apply","12 Years","100 Years",{"count":147,"type":22},36,[149],"PHASE4","The purpose of this study is to assess the efficacy and safety of ruxolitinib therapy in Chinese adults and adolescents (≥ 12 years old) with Grade II-IV steroid-refractory acute graft versus host disease (SR-aGvHD).",[152],"Steroid-refractory Acute Graft Versus Host Disease",[154,155,156,157,158,159,160,161],"SR-aGvHD","aGvHD","acute graft-versus-host disease","ruxolitinib","Chinese patients","corticosteroid-refractory","Grade II-IV","Grade II to IV",{"date":40,"type":41},{"date":164,"type":41},"2024-07-04",{"date":166,"type":22},"2027-06-21",{"name":47,"class":48},17,{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":177,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":23,"phases":180,"briefSummary":182,"conditions":183,"keywords":186,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},"100545449","modifying-pest-for-psoriatic-arthritis-screening-100545449","NCT06382051","Modifying PEST for Psoriatic Arthritis Screening","A Multicenter, Prospective, Study to Evaluate the Impact of Modifying the Validated Psoriasis Epidemiology Screening Tool (PEST) on the Potential Diagnosis of Psoriatic Arthritis in Adult Patients With Moderate-to-severe Plaque Psoriasis in Canada (\"ScreenX\")","ScreenX","Key inclusion criteria:\n\n1. Moderate-to-severe plaque PsO patients who are candidates for bDMARDs, according to physician's clinical judgement at the time of patient enrollment.\n2. Adult patients at the time of informed consent signature\n3. Patients able to understand and willing to comply with protocol requirements, instructions, and restrictions\n4. Residents of Canada\n\nKey exclusion criteria:\n\n1. Patients who have previously screened positive for PsA through PEST.\n2. Patients who have been diagnosed with PsA.\n3. Patients who have been diagnosed with inflammatory arthritis unrelated to PsA (rheumatoid arthritis, reactive arthritis, enteropathic arthritis, axial spondyloarthritis)\n4. Patients treated with a bDMARD for moderate-to-severe plaque PsO or any other medical condition within the last 6 months prior to patient enrollment.",true,{"count":179,"type":22},502,[181],"NA","The purpose of this study is to assess the impact of adding two questions and pictures to the validated PEST on the potential diagnosis of PsA in participants with moderate-to-severe plaque PsO in Canada.",[184,185],"Plaque Psoriasis","Psoriatic Arthritis",[187,185,188,184,189,190,191],"Psoriasis","PsA","PsO","Implementation Science","Psoriasis Epidemiology Screening Tool",{"date":40,"type":41},{"date":194,"type":41},"2025-01-23",{"date":196,"type":22},"2026-12-31",{"name":47,"class":48},30,{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":145,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":5},"100502809","phase-3-phase-iiib-study-of-ribociclib--et-in-early-breast-cancer-100502809","NCT05827081","Phase IIIb Study of Ribociclib + ET in Early Breast Cancer","A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)","Adjuvant WIDER","Key Inclusion criteria:\n\n* Participant is an adult, male or female ≥ 18 years of age at the time of informed consent form signature (IC).\n* Participant has a histologically and\u002For cytologically confirmed diagnosis of estrogen-receptor positive and\u002For progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample tested by a local laboratory prior to enrollment.\n* Participant has HER2- BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing based on the most recently analyzed tissue sample.\n* Participants may have already received any standard neoadjuvant and\u002For adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrollment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy.\n* For participants with prior ET treatment \\> 12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrollment.\n* The number of participants with prior ET between 12 and 36 months will be capped at 30%. The cap will not apply to Black or African American participants.\n* Participant has no contraindication to receive adjuvant ET in the study.\n* Participant after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:\n\n  * Anatomic Stage Group III, or\n  * Anatomic Stage Group IIB, or\n  * A subset of Anatomic Stage Group IIA.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.\n* Participant has adequate bone marrow and organ function.\n* ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as:\n\n  * QTcF interval at Screening \\\u003C 450 msec (QT interval using Fridericia's correction).\n  * Mean resting heart rate 50-99 beats per minute (determined from the ECG).\n\nKey Exclusion criteria:\n\n* Participant with distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and\u002For evidence of recurrence after curative surgery.\n* Participant is concurrently using other antineoplastic therapy with the exception of adjuvant ET.\n* Participant has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate participant participation in the clinical study or compromise compliance with the protocol, or limit life expectancy to ≤5 years.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality.\n* Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.\n* Women of child-bearing potential (CBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 21 days after stopping the treatment.\n\nOther inclusion\u002Fexclusion criteria may apply",{"count":208,"type":22},1400,[61],"The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).",[212],"Early Breast Cancer",[214,215,216,217,218,219,220,221,222],"Hormone receptor positive (HR+)","Human epidermal growth factor receptor-2 negative (HER2-)","Early breast cancer (EBC)","premenopausal","postmenopausal","male breast cancer","ribociclib","LEE011","Endocrine therapy (ET)",{"date":40,"type":41},{"date":225,"type":41},"2024-02-28",{"date":227,"type":22},"2030-09-20",{"name":47,"class":48},{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":145,"enrollmentInfo":236,"targetDuration":4,"studyType":238,"phases":4,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":254,"locationsCount":255},"100652916","a-study-comparing-effectiveness-of-kesimpta-ofatumumab-versus-ocrevus-ocrelizumab-in-real-world-practice-100652916","NCT07779460","A Study Comparing Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice","Comparative Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice: A Retrospective Study","Inclusion criteria:\n\nPatients in the pooled OMB and pooled OCR cohorts are required to meet the following eligibility criteria:\n\n* ≥1 incident claim for OMB (pooled OMB cohort) or OCR (pooled OCR cohort) in the patient identification period.\n* No claims for OMB or OCR within the 12 months prior to the index date. The index date is the date of the first OMB or OCR claim.\n* ≥2 outpatient (OP) medical claims (at least 30 days apart) with a diagnosis code for MS (International Classification of Diseases, Tenth Revision, Clinical Modification \\[ICD-10-CM\\] code: G35) in any position, with the first claim occurring in the 12 months prior to or on index date and the second claim up to 6 months after index date, or ≥1 inpatient (IP) claim with MS recorded as the primary diagnosis in the 12 months prior to or on index date.\n* ≥18 years of age on index date.\n* Continuous healthcare plan enrollment for ≥12 months prior to index date and ≥6 months after index date.\n* Persistent use of OMB (pooled OMB cohort) or OCR (pooled OCR cohort) for ≥6 months after index date.\n\nPatients in the treatment-naïve OMB and treatment-naïve OCR cohorts are required to meet the following eligibility criteria:\n\n* Included in pooled OMB cohort or pooled OCR cohort.\n* No claims for a disease-modifying therapy (DMT) used for the treatment of MS in the 12-month baseline period.\n\nExclusion criteria:\n\n• Patients who do not meet the study inclusion criteria.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":237,"type":22},7466,"OBSERVATIONAL","This study aims to generate real-world evidence on the clinical effectiveness and economic burden of ofatumumab (OMB) versus ocrelizumab (OCR) in patients diagnosed with multiple sclerosis (MS) in the United States (US). Clinical effectiveness will be assessed using annualized relapse rate (ARR), while economic burden will be assessed using healthcare resource utilization (HCRU) and healthcare costs (HCC). This study will use two primary data sources that capture longitudinal, de-identified healthcare utilization derived from claims submitted for reimbursement.",[241],"Multiple Sclerosis",[243,244,245,246,247,248],"Multiple sclerosis","Ofatumumab","Ocrelizumab","Anti-CD20 therapy","Comparative effectiveness","Real-world evidence","2026-08-18",{"date":40,"type":41},{"date":252,"type":41},"2026-04-08",{"date":196,"type":22},{"name":47,"class":48},1,{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":177,"sex":18,"minAge":19,"maxAge":263,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":267,"conditions":268,"keywords":270,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":255},"100642243","phase-1-a-first-in-human-study-to-investigate-single-doses-of-dcy636-in-healthy-volunteers-and-multiple-doses-in-participants-with-moderate-to-severe-atopic-dermatitis-100642243","NCT07604324","A First-in-human Study to Investigate Single Doses of DCY636 in Healthy Volunteers and Multiple Doses in Participants With Moderate to Severe Atopic Dermatitis","A Two-part, Randomized, Participant- and Investigator-blinded, Placebo Controlled First-in-human Study to Investigate the Safety, Tolerability and Pharmacokinetics of DCY636 in a Single Ascending Dose Part in Healthy Participants and in a Multiple Dose Part in Participants With Moderate to Severe Atopic Dermatitis","Key Inclusion Criteria:\n\nHealthy Participants (Part 1)\n\n• Healthy male and non-childbearing potential female participants 18 to 55 years of age inclusive.\n\nParticipants with moderate to severe atopic dermatitis (Part 2)\n\n* Males and non-pregnant females age 18 years or older\n* Diagnosis of atopic dermatitis for at least 1 year not adequately controlled by topicals\n* Moderate to severe atopic dermatitis as defined by all of the following:\n\n  * EASI score ≥12 at screening visit and ≥16 at baseline (BL) visit\n  * IGA score ≥3 at screening visit and baseline visit\n  * Total Body surface area (BSA) affected by AD ≥ 10 % at screening visit and baseline visit\n  * Peak Pruritus NRS score ≥4 at baseline visit, based on weekly average of daily assessment in the week prior to baseline visit\n\nKey Exclusion Criteria:\n\nAll Participants (Part 1, Part 2)\n\n* Use of other investigational drugs within the last 30 days or 5 half-lives of the other drugs prior to initial dosing, whichever is longer.\n* Meet any of the prohibited medication use criteria at baseline visit.\n* A positive syphilis test result during screening period.\n* Evidence of active or latent TB infection, as determined by T-Spot test during screening period.\n* History of immunodeficiency diseases, or a positive human immunodeficiency virus (HIV) test result.\n* Recent (within last half year) or ongoing helminth infection.\n* History of hepatitis B or hepatitis C or serologic evidence for viral hepatitis. A positive Hepatitis B virus surface antigen (HBsAg), Hepatitis B virus core antibody (HBcAb) and\u002For Hepatitis B surface antibody (HBsAb) test during screening period excludes a participant. A positive test for HBsAb can be included if the test for HBsAg and HBcAb are negative and the history of hepatitis B vaccination is known. Participants with a positive Hepatitis C virus (HCV) antibody test should be excluded.\n\nHealthy Participants (Part 1)\n\n* Women of childbearing potential\n* Smokers Participants with moderate to severe atopic dermatitis (Part 2)\n* Regular use (more than 2 visits per week) of a tanning booth\u002Fparlor or extended sun exposure (per investigator judgement) within 4 weeks prior to baseline visit\n* Have any chronic, uncontrolled medical condition, which would put the participant at increased risk during study participation, such as uncontrolled: diabetes, hypertension, morbid obesity, thyroid, adrenal, cardiovascular, pulmonary, hepatic, renal, neurologic or psychiatric disease, or other disease of concern, as per investigator judgment\n* Women of childbearing potential (WOCBP) are excluded unless they are using highly effective methods of contraception (failure rate \\\u003C 1% per year) while taking study treatment and for 202 days (= 5 times the terminal half-life) of study treatment after stopping study treatment.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","55 Years",{"count":265,"type":22},63,[91],"The purpose of this first-in-human (FIH) study is to assess the safety and tolerability, pharmacokinetics (PK), immunogenicity (IG) and pharmacodynamics (PD) of DCY636. The results are intended to support the further clinical development of DCY636 in future studies.",[269],"Dermatitis, Atopic",[271,272,273,274,275,276,277,278],"Phase 1","FIH","safety and tolerability","healthy volunteers","PK","atopic dermatitis","AD","eczema",{"date":280,"type":41},"2026-08-19",{"date":282,"type":41},"2026-06-02",{"date":284,"type":22},"2028-01-28",{"name":47,"class":48},{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":145,"enrollmentInfo":293,"targetDuration":4,"studyType":23,"phases":295,"briefSummary":296,"conditions":297,"keywords":299,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":147},"100628073","phase-3-remibrutinib-open-label-roll-over-post-trial-access-protocol-100628073","NCT07456891","Remibrutinib Open Label Roll-over Post-trial Access Protocol","An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Remibrutinib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Remibrutinib.","Inclusion Criteria:\n\n\\- Participant has completed treatment per protocol in a Novartis study of remibrutinib (unless otherwise specified in a parent study protocol) in a dermatological or allergology indication.\n\nParticipants, who derive benefit from the treatment with remibrutinib but have not completed the treatment in certain parent studies due to parent study termination by Novartis, may be eligible if the termination was due to reasons other than safety or lack of efficacy (e.g., technical \u002F administrative reasons).\n\n* Participant is deriving benefit from remibrutinib, investigator believes he\u002Fshe would continue to derive benefit from remibrutinib and the benefit outweighs the risk, based on the investigator's judgement.\n* Participant is unable to obtain access to the marketed remibrutinib formulation per local post study drug supply program, prescription and\u002For reimbursement guidelines.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria are not eligible for inclusion in this study.\n\n* Participant has prematurely discontinued study treatment in the parent study.\n* Use of prohibited medications",{"count":294,"type":22},648,[61],"Multi-center, open-label roll-over post-trial access protocol to provide remibrutinib treatment and collect long-term safety for up to three years for participants who are currently receiving remibrutinib treatment in a Novartis-sponsored study, who are benefiting from treatment with remibrutinib, and are unable to access remibrutinib treatment outside of a clinical study.",[298],"Indication of the Parent Protocol",[300,301,302,303,304],"Remibrutinib","long-term","roll-over","open label","post-trial access",{"date":280,"type":41},{"date":307,"type":41},"2026-04-16",{"date":309,"type":22},"2033-01-30",{"name":47,"class":48},{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":18,"minAge":318,"maxAge":319,"enrollmentInfo":320,"targetDuration":4,"studyType":238,"phases":4,"briefSummary":322,"conditions":323,"keywords":325,"overallStatus":328,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":329,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":4},"100627916","a-study-of-patient-characteristics-co-morbidities-and-treatment-patterns-in-chronic-myeloid-leukemia-patients-in-kuwait-100627916","NCT07454850","A Study of Patient Characteristics, Co-Morbidities, and Treatment Patterns in Chronic Myeloid Leukemia Patients in Kuwait","Retrospective Study on Patient Characteristics, Co-Morbidities, and Treatment Patterns in Chronic Myeloid Leukemia (CML) in Kuwait","Inclusion criteria\n\n* Diagnosed with Ph+ve CML based on the European LeukemiaNet (ELN) and National Comprehensive Cancer Network (NCCN) diagnostic criteria.\n* Received at least one line of TKI therapy.\n* Having a documented pre-index period (equal to either 6 months prior to the index date or less in case of newly diagnosed patients).\n\nExclusion criteria\n\n• Patients not fulfilling any of the above-mentioned inclusion criteria.","21 Years","90 Years",{"count":321,"type":22},400,"The aim of this study is to assess demographics, clinical features, treatment patterns, and the comorbidity burden and its impact on CML patients in the real-world clinical setting in Kuwait. Adult patients with Philadelphia positive-chromosome (Ph+ve) CML who have received at least one line of tyrosine kinase inhibitor (TKI) treatment, such as but not limited to imatinib, dasatinib, nilotinib, bosutinib, ponatinib, and asciminib will be included. The study will use data from the hospital records of CML patients between January 2014 and January 2024.",[324],"Leukemia, Myeloid, Chronic-Phase",[326,327],"CML","Chronic Myeloid Leukemia","NOT_YET_RECRUITING",{"date":38,"type":41},{"date":331,"type":22},"2026-08-30",{"date":333,"type":22},"2026-10-16",{"name":47,"class":48},{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":18,"minAge":342,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":23,"phases":345,"briefSummary":346,"conditions":347,"keywords":349,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":353,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":359},"100626900","phase-2-a-study-to-investigate-efficacy-and-safety-of-fwy003-compared-with-placebo-in-participants-with-geographic-atrophy-secondary-to-age-related-macular-degeneration-100626900","NCT07441642","A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration","A Randomized, Double Masked, Placebo-controlled, Multicenter, Dose-range Finding Study to Assess the Efficacy and Safety of FWY003 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration","Inclusion Criteria:\n\nMale or female participants ≥ 50 years of age.\n\n* A diagnosis of GA secondary to AMD in at least one eye (study eye). If both eyes qualify, then the eye with the better BCVA would be assigned as study eye.\n\n  1. Total GA area must be ≥2.5 and ≤17.5 mm2 (1 and 7 disk areas (DA), respectively)\n  2. If GA lesion is multifocal, then the total lesion area must be between 2.5-17.5 mm2 and at least one lesion should have an area of at least 1.25 mm2\n  3. Entire GA lesion must be visualized on the macula centered image and not contiguous with peripapillary atrophy\n* ETDRS BCVA ≥ 35 letters (20\u002F200) in the study eye.\n\nExclusion Criteria:\n\n* A history of, or current evidence of, choroidal neovascularization (exudative MNV) in the study eye.\n* Previous cell or gene therapy in either eye.\n* Macular atrophy in either eye due to a cause other than AMD, such as Stargardt disease, cone rod dystrophy, toxic maculopathies, etc.\n* Intraocular surgery, including cataract and vitreoretinal surgery, in the study eye within 3 months prior to Baseline.\n* Presence of significant media opacity, eye movement disorder (nystagmus), severe ptosis, extraocular motility restriction or head tremor, which in the opinion of the investigator, would prevent adequate fundus visualization or which in the opinion of the Reading Center could interfere with the assessment of study images.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","50 Years",{"count":344,"type":22},272,[25],"To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).",[348],"Geographic Atrophy Secondary to Age-related Macular Degeneration",[350,127,351,352],"FWY003","tolerability","geographical atrophy",{"date":38,"type":41},{"date":355,"type":41},"2026-03-09",{"date":357,"type":22},"2029-08-22",{"name":47,"class":48},51,{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":368,"enrollmentInfo":369,"targetDuration":4,"studyType":23,"phases":371,"briefSummary":372,"conditions":373,"keywords":375,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":381,"startDateStruct":382,"completionDateStruct":383,"leadSponsor":385,"locationsCount":386},"100626095","phase-2-a-phase-iib-dose-ranging-study-to-assess-the-efficacy-and-safety-of-gia632-in-participants-with-non-segmental-vitiligo-100626095","NCT07431177","A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo","A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase IIb Study to Assess the Efficacy and Safety of GIA632 in Adult Participants With Non-segmental Vitiligo Followed by an Extension Period","VITESS","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study\n* Male or female as assigned at birth ≥ 18 years of age at the time of screening\n* Individuals with a diagnosis of non-segmental vitiligo and confirmation of diagnosis through physical examination by the investigator\n* Non-segmental vitiligo, as assessed at screening, as\n* ≥ 0.5% Body Surface Area (BSA) on the face and F-VASI score ≥ 0.5\n* ≥ 3% BSA on non-facial areas (minimum of 3% should be calculated in addition to hands and feet) and T-VASI score = 3 to 60\n\nExclusion Criteria:\n\n* Individuals unable or unwilling to follow the study procedures and\u002For to complete the study-related questionnaires\n* Presence of segmental or mixed vitiligo, or other skin comorbidities that may interfere with study assessments (e.g., hypopigmented mycosis fungoides, genetic diseases with pigmentary aberrations \\[such as piebaldism, Waardenburg, etc.\\], chemical- or druginduced leukoderma, etc.)\n* Previous exposure to biologic drugs directly targeting IL-15 or IL-15 receptors\n* Individual who previously attempted or completed depigmentation therapy for NSV\n* Use of prohibited medication \\& treatments. Other protocol-defined inclusion\u002Fexclusion criteria may apply","99 Years",{"count":370,"type":22},210,[25],"The main purpose of this multicenter, randomized, double-blind, placebo-controlled Phase 2b study is to investigate the safety and efficacy of GIA632 in participants with NSV and to identify the optimal dose to be promoted into the confirmatory Phase 3 program.",[374],"Non-segmental Vitiligo",[376,377,378,379,127,380],"Phase 2b","interventional","vitiligo","efficacy","dose ranging",{"date":280,"type":41},{"date":355,"type":41},{"date":384,"type":22},"2030-01-28",{"name":47,"class":48},72,{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":18,"minAge":394,"maxAge":19,"enrollmentInfo":395,"targetDuration":4,"studyType":23,"phases":397,"briefSummary":398,"conditions":399,"keywords":402,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":415,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":421},"100620165","phase-2-study-to-determine-the-efficacy-and-safety-of-asciminib-in-pediatric-patients-with-ph-cml-cp-100620165","NCT07354074","Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP","A Phase II, Multicenter, Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Asciminib in Pediatric Participants Newly Diagnosed or Previously Treated With Philadelphia Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) With or Without Known T315I Mutation","Key Inclusion Criteria:\n\nParticipants eligible for inclusion in this study must meet all of the following criteria:\n\n1. Signed informed consent must be obtained prior to participation in the study.\n2. Male or female participants 1 and \\\u003C 18 years of age at study enrollment\n3. Diagnosis of CML-CP (Apperley et al 2025) with cytogenetic confirmation of Philadelphia positive (Ph+) chromosome\n4. For participants with CML-CP newly diagnosed within 3 months of screening OR 5 For participants with CML - CP with high risk of developing resistance or intolerance to previous TKI:\n\n   1. Unfavourable response to TKI is defined following the Apperley et al 2025 guidelines as:\n\n      * At three months after the initiation of therapy: BCR::ABL1 ratio \\> 10% IS (if confirmed within 1-3 months)\n      * At six months after the initiation of therapy: BCR::ABL1 ratio \\> 10% IS\n      * At twelve months after initiation of therapy: BCR::ABL1 ratio \\> 1% IS\n      * At any time loss of previous response\n      * At any time emergent resistant BCR::ABL1 mutations or high-risk ACA from prior TKI treatment as per local test results\n   2. Intolerance to TKI is defined as:\n\n      * Non-hematologic intolerance: participants with grade 3 or 4 toxicity while on therapy (in which case the patient is eligible whether or not there was a dose reduction); or with persistent grade 2 toxicity unresponsive to optimal management including dose adjustments (unless dose reduction is not considered in the best interest of the patient if response is already suboptimal)\n      * Hematologic intolerance: participants with grade 3 or 4 toxicity (absolute neutrophil count \\[ANC\\] or platelets) while on therapy that is recurrent after dose reduction to the lowest doses of the TKI\n\n6\\. Evidence of typical BCR::ABL1 transcript \\[e14a2 and\u002For e13a2\\] at the time of screening which are amenable to standardized RQ-PCR quantification.\n\n7\\. Performance status: Karnofsky ≥ 50% for participants ≥ 16 years of age, and Lansky ≥ 50 for participants \\\u003C 16 years of age at the time of screening.\n\nKey Exclusion Criteria:\n\n1. Known second chronic phase (CP) of CML after previous progression to Accelerated Phase (AP)\u002FBlast Phase (BP).\n2. Previous treatment with a hematopoietic stem-cell transplantation.\n3. Patient planned to undergo allogeneic hematopoietic stem cell transplantation\n4. Known presence of a BCR::ABL1 mutation with known resistance to study treatment in accordance with the most recent public version of international CML clinical guidelines (e.g. NCCN CML treatment guidelines v 1.2026 and Apperley et al 2025) any time prior to study entry\n\nOther inclusion\u002Fexclusion criteria may apply.","1 Year",{"count":396,"type":22},50,[25],"The aim of this study is to support development of asciminib in the pediatric population (1 to \\\u003C 18 years) with Ph+ CML-CP. The study will evaluate the efficacy and safety of asciminib in pediatric formulation (weigh-based dose, fed state) or adult formulation (fasted) in newly diagnosed and resistant or intolerant Ph+ CML-CP with or without T315I mutation.",[400,401],"Chronic Myelogenous Leukemia","Leukemia, Myelogenous, Chronic, Philadelphia Chromosome Positive",[403,404,405,406,407,408,409,410,411,326,412,413,414],"Asciminib","ABL001","Pediatric participants","Philadelphia chromosome positive chronic myeloid leukemia in chronic phase","Ph+ CML-CP","tyrosine kinase inhibitor","TKI","Molecular Response","MR","Chronic phase","T3151","Ph+",{"date":38,"type":41},{"date":417,"type":41},"2026-04-28",{"date":419,"type":22},"2033-02-23",{"name":47,"class":48},28,{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":177,"sex":18,"minAge":19,"maxAge":342,"enrollmentInfo":430,"targetDuration":4,"studyType":23,"phases":432,"briefSummary":433,"conditions":434,"keywords":436,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":442,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":448},"100612121","phase-2-study-testing-the-efficacy-safety-and-tolerability-of-edi048-in-cryptosporidium-infection-model-in-healthy-adults-100612121","NCT07249463","Study Testing the Efficacy, Safety, and Tolerability of EDI048 in Cryptosporidium Infection Model in Healthy Adults","A Randomized, Placebo-controlled, Participant- and Investigator-blinded Study to Assess the Efficacy and Safety and Tolerability of EDI048 in a Cryptosporidium Controlled Human Infection Model (CHIM) in Healthy Participants","CRYPTONITE","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Ability to communicate well with the Investigator, and to understand and comply with the requirements of the study.\n* Male and female participants must be between 18 to 50 years of age and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at Screening and Baseline.\n* Demonstrate thorough understanding of cryptosporidiosis and measures to prevent secondary spread via education provided at screening.\n* Must have a body mass index (BMI) within the range of 18-32 kg\u002Fm2. BMI = Body weight (kg) \u002F \\[Height (m)\\]2\n* Have not received ABO809 or EDI048 in prior clinical trials.\n\nExclusion Criteria:\n\n* History of Cryptosporidium infection.\n* Current (based on screening laboratory tests) or history of infectious diarrhea associated with international travel in the last 12 months or C. difficile infection within 6 months prior to Screening.\n* Employment as a healthcare worker with direct patient care, in a daycare center (e.g., for children or the elderly), or direct food handler (individuals who work directly with food in commercial establishments).\n* Participants who share a home with any of the following:\n* a pregnant woman,\n* a person \\\u003C4 years old or \\>65 years old,\n* a person who is infirmed,\n* a person who is immunocompromised (for reasons including corticosteroid therapy, HIV infection, cancer chemotherapy, or other chronic debilitating disease).\n* Residents of dormitories with shared bathrooms would also be excluded.\n* Any significant medical history including, but not limited to, conditions of the cardiac, pulmonary, gastrointestinal, renal, endocrine, reproductive, immune or other systems.\n* Use of investigational drugs within 5 half-lives of the drug or its major metabolites or 30 days of enrollment (Day 1), whichever is longer.\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the trial; pregnant or nursing (lactating) women.",{"count":431,"type":22},80,[25],"This study has the purpose to demonstrate prospect of benefit of EDI048 on clinical signs and symptoms of cryptosporidiosis to facilitate trial in target population, pediatric patients.\n\nThis study aims to investigate the efficacy of a new chemical entity, EDI048, in a controlled human infection model of cryptosporidiosis induced by administration of ABO809 in healthy adults, who become symptomatic with disease thereby demonstrating a prospect of benefit for use of EDI048 in children afflicted with cryptosporidiosis.",[435],"Cryptosporidiosis",[435,437,438,439,440,441],"Cryptosporidium","EDI048","ABO809","Controlled human infection model","CHIM",{"date":280,"type":41},{"date":444,"type":41},"2025-12-08",{"date":446,"type":22},"2027-03-23",{"name":47,"class":48},2,{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":177,"sex":18,"minAge":19,"maxAge":456,"enrollmentInfo":457,"targetDuration":4,"studyType":23,"phases":459,"briefSummary":460,"conditions":461,"keywords":463,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":468,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":448},"100611013","phase-1-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-ojr520-in-healthy-volunteers-and-participants-with-chronic-kidney-disease-100611013","NCT07235059","Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease","A Participant- and Investigator--Blinded, Placebo- Controlled, Randomized, Multipart, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease","Inclusion Criteria:\n\nAble to provide written informed consent before any assessment is performed.\n\nPart A (HV):\n\n• Healthy male and female participants in good health as determined by past medical history, physical examination, vital signs, 12-lead ECG, and laboratory tests at screening and baseline within the normal range.\n\nParts B \\& C (CKD)\n\n• Male and female participants 18 to 65 years of age.\n\nExclusion Criteria:\n\n* Women of childbearing potential.\n* Sexually active males unwilling to use contraception.\n\nPart A (HV):\n\n* Clinically significant abnormal blood pressure, defined as SBP \\\u003C90 mmHg or \\>140 mmHg or DBP \\\u003C55 mmHg or \\>95 mmHg.\n* Abnormal resting HR, defined as \\\u003C45 bpm or \\>90 bpm.\n\nPart B \\& C (CKD)\n\n* History of, or currently active, significant illness or medical disorders including, but not limited to, cancer (except for non-melanoma skin cancer), heart failure NYHA III-IV, heart rhythm abnormalities (e.g., atrial fibrillation, sick sinus syndrome, permanent pacemaker), CKD due to autoimmune disease, kidney transplant, dialysis or any other disease the investigator believes may preclude the participant from participating in the this study.\n* Clinically significant aortic stenosis or mitral insufficiency as identified via echocardiography.\n* History of myocardial infarction (MI), stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), or transient ischemic attack (TIA).\n\nOther protocol defined inclusion\u002Fexclusion criteria may apply.","65 Years",{"count":458,"type":22},112,[91],"The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.",[462],"Chronic Kidney Disease",[464,273,275,465,274,466,467],"OJR520","PD","first in human","chronic kidney disease",{"date":280,"type":41},{"date":470,"type":41},"2025-11-20",{"date":472,"type":22},"2028-01-21",{"name":47,"class":48},{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":18,"minAge":394,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":486,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":503},"100608549","phase-2-a-phase-ii-trial-to-evaluate-the-clinical-efficacy-safety-and-tolerability-of-mas825-in-pediatric-and-adult-participants-with-stills-disease-100608549","NCT07203001","A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease","An Open-label Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease","Inclusion Criteria:\n\n* Age ≥ 1 with a diagnosis of Still's Disease\n* Active diseases defined as:\n* CRP or ferritin levels greater than ULN, and any of:\n\n  * Fever ≥ 38°C attributed to Still's Disease activity and documented for a number of days prior to Day 1 or\n  * Rash attributed to Still's Disease activity or\n  * Musculoskeletal involvement: arthritis in a number of joints per ACP criteria for active joint or\n  * Serositis or\n  * Macrophage activation syndrome activity as defined by ferritin levels and at least one of: platelet count, a biomarker or fibrinogen levels attributed to Still's Disease activity by the investigator\n* Intolerance or inadequate response to available biologic therapy\n\nExclusion Criteria:\n\n* Patients out of weight range\n* Ongoing or previous treatment with immunomodulatory drugs\n\n  * A limited number of Still's Disease patients that have previously received MAS825 through a managed access program are permitted on the study\n* Glucocorticoid dose exceeding a set limit\n* Any conditions or significant medical problems which places the patient at unacceptable risk for MAS825 therapy\n\n  * Still's disease patients with evidence of macrophage activation syndrome are permitted in the study\n  * Still's Disease patients with evidence of interstitial lung disease including those requiring supplemental oxygen therapy are permitted in the study\n* History of ongoing, chronic or possibly recurrent infection (e.g. HIV, TB, HCV, HBV) and\u002For symptoms and signs of clinically significant active bacterial, fungal or viral infections\n* Live vaccinations within a set time prior to MAS825 treatment. Live vaccines are prohibited up to several months following the last dose\n* History of malignancy of any organ system, including post-transplant lymphoproliferative disorder, treated or untreated, within a number of years, regardless of whether there is evidence of local recurrence and metastases\n* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or to any of the excipients\n* Pregnant or breastfeeding women\n* Women of child-bearing potential who do not agree to comply with required contraceptive use\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":198,"type":22},[25],"The study is a phase II trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 (arumakimig) in pediatric and adult participants with Still's disease",[485],"Still´s Disease",[487,488,489,490,491,492,493,494,495,496],"Still´s disease","pediatric","adult","sJIA","AOSD","Systemic Juvenile Idiopathic Arthritis","Adult Onset Still s disease","rheumatology","MAS825","arumakimig",{"date":280,"type":41},{"date":499,"type":41},"2025-11-03",{"date":501,"type":22},"2028-05-17",{"name":47,"class":48},23,{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":145,"enrollmentInfo":511,"targetDuration":4,"studyType":23,"phases":513,"briefSummary":514,"conditions":515,"keywords":517,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":522,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":528},"100588944","phase-2-platform-study-to-evaluate-the-efficacy-and-safety-of-investigational-compounds-in-patients-with-moderate-to-severe-atopic-dermatitis-100588944","NCT06947993","Platform Study to Evaluate the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis","A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Platform Study to Assess the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis","Key Inclusion Criteria of the master protocol:\n\n* Able and willing to sign the informed consent (IC)\n* Patients with a diagnosis of AD and onset of disease for at least 1 year\n* Moderate to severe AD\n\nKey Exclusion Criteria of the master protocol:\n\n* Participants with a clinically significant medical condition or infectious disease (specified in sub-protocol)\n* Participants with clinically significant abnormal hematology, clinical chemistry, or urine test results or clinically significant abnormal ECG\n* Participant with any other active inflammatory skin disease\n* Participants with any chronic, uncontrolled medical condition, which would put the participant at increased risk during the study (e.g., uncontrolled: diabetes, hypertension)\n* Participants with any clinically unstable disease states that would likely require systemic corticosteroids (e.g., uncontrolled asthma)\n\nAdditional inclusion and exclusion criteria may apply depending on the intervention specific requirements",{"count":512,"type":22},224,[25],"This trial is designed to evaluate multiple compounds in participants with moderate to severe atopic dermatitis (AD).",[516],"Atopic Dermatitis",[518,519,520,521],"Atopic dermatitis","Dermatitis","Eczema","Moderate to severe",{"date":280,"type":41},{"date":524,"type":41},"2025-05-16",{"date":526,"type":22},"2028-12-22",{"name":47,"class":48},105,{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":23,"phases":538,"briefSummary":539,"conditions":540,"keywords":542,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":548,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":554},"100582815","phase-3-a-study-to-evaluate-efficacy-of-remibrutinib-compared-to-dupilumab-at-early-timepoints-in-adults-with-chronic-spontaneous-urticaria-inadequately-controlled-by-second-generation-h1-antihistamines-100582815","NCT06868212","A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines","A US Phase 3b, Multi-center, Randomized, Double-blind, Double-Dummy Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-Antihistamines","RECLAIM","Inclusion Criteria:\n\n* Adults ≥ 18 years of age at the time of signing the informed consent\n* CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined by the Investigator based on all available supporting documentation)\n* Diagnosis of CSU inadequately controlled by sgH1-AH at the time of randomization, defined as:\n* The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of sgH1-AH during the 7 days prior to randomization (Day 1):\n* UAS7 score (range, 0-42) ≥ 16, and\n* ISS7 score (range, 0-21) ≥ 6, and\n* HSS7 score (range, 0-21) ≥ 6\n* Documentation of hives within 3 months before randomization (either at screening and\u002For at randomization); or documented in the participants medical history\n* Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol\n* Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1)\n\nExclusion Criteria:\n\n* Previous use of remibrutinib or other bruton's tyrosine kinase (BTK) inhibitors\n* Previous use of dupilumab\n* Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA Class III\u002FIV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Visit 1), neurological, psychiatric, pulmonary, renal, hepatic (past history or current), endocrine or metabolic disorder, or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.\n* Evidence of hematological disorders (including coagulation disorders or significant bleeding risk)\n* History or evidence of gastrointestinal disease (including gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion)\n* Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg\u002Fd or clopidogrel up to 75 mg\u002Fd. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited.\n* Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants \\[NOAC\\])\n* History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or hepatic parameters at screening: Aspartate Aminotransferase (AST)\u002F Alanine Aminotransferase (ALT) levels more than 1.5x ULN or International Normalized Ratio (INR) \\> 1.5 at screening",{"count":321,"type":22},[61],"This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily \\[b.i.d.\\] by mouth \\[p.o.\\]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.",[541],"Chronic Spontaneous Urticaria (CSU)",[543,544,545,546,547],"BTK inhibitor","chronic spontaneous urticaria","Urticaria activity score","Hives severity score","Itch severity score",{"date":280,"type":41},{"date":550,"type":41},"2025-07-11",{"date":552,"type":22},"2027-05-17",{"name":47,"class":48},133,{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":23,"phases":564,"briefSummary":565,"conditions":566,"keywords":568,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":581,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":168},"100582618","phase-2-study-of-remibrutinib-lou064-efficacy-and-safety-and-exploration-of-its-mechanism-of-action-in-participants-with-chronic-urticaria-100582618","NCT06865651","Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria","A 12-week Randomized, Participant and Investigator-blinded, Placebo-controlled, Exploratory Study in Adult Participants With Chronic Urticaria to Assess the Efficacy and Safety and Explore the Mechanism of Action of Remibrutinib (LOU064)","Inclusion Criteria:\n\n1. Signed informed consent must be obtained prior to participation in the study.\n2. Male and female participants ≥ 18 years of age at the time of signing of the informed consent forms.\n3. CINDU patients: Confirmed diagnosis of CINDU with a duration of ≥ 4 months (defined as onset of CINDU with supporting documentation (e.g. medical record, clinical history, photographs) and inadequate control with H1-AH at local label approved doses at the time of randomization. The response to the provocation test for each CINDU subtype is required before randomization (either during screening or prior to randomization on Day 1):\n4. CINDU patients: Patients should be symptomatic for their most bothersome symptom as assessed with the USDD during baseline with a NRS score of 3 or more\n5. CSU patients: Diagnosis of CSU (acc. to Zuberbier et al 2022c) not adequately controlled with H1-AH at approved doses alone for at least 4 weeks prior to randomization, as defined by all of the following:\n\n   * UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during 7 days prior to randomization\n   * CSU for ≥ 6 months\n6. Participants must be willing and able to attend the protocol defined test procedure throughout the study.\n\nExclusion Criteria:\n\n1. Participants who have a familial\u002Fhereditary form (e.g. familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study.\n2. Diseases, other than CSU or CINDU, with urticaria or angioedema symptoms including but not limited to:\n\n   * urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa),\n   * food allergies yielding urticaria symptoms when the allergen is not avoided by the dietary habits of the participant\n   * hereditary or acquired angioedema.\n3. CINDU patients only: To prevent any confounding effect of CSU symptoms, the CINDU study population will consist of participants with predominant CINDU and should not have a significant share of CSU symptoms (that might make the assessment of CINDU symptoms difficult) as per the investigator's judgement.\n4. CSU patients only: Patients should have no relevant inducible urticaria trigger\n5. Any other skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism\n6. Known or suspected ongoing, chronic or recurrent infectious disease including but not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and\u002For known positivity for Human Immunodeficiency Virus (HIV) infection.\n7. Evidence of an ongoing Hepatitis C infection (defined by the detection at screening of Hepatitis C virus antibodies (anti-HCVAb) and hepatitis C ribonucleic acid (HCV-RNA) in participants who are positive for anti-HCVAb) and\u002For an ongoing Hepatitis B infection (defined by the detection of Hepatitis B virus surface antigen (HBsAg) and\u002For hepatitis B virus (HBV)-DNA at screening; participants who are positive for anti-hepatitis B core (HBc) antibodies but who are negative for antibodies against HBsAg and HBV-DNA can be included into the study if they agree to monitoring for HBsAg and HBV-DNA reactivation).\n8. Major surgery within 8 weeks prior to screening or planned surgery for the duration of the study.\n9. Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA Class III\u002FIV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Screening), neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.\n10. Uncontrolled disease states, such as asthma, or inflammatory bowel disease, or any other disease where flares are commonly treated with oral or parenteral corticosteroids.\n11. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).\n12. History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN values, or abnormal urinary constituents (e.g. proteinuria, hematuria)\n\n    * Evidence of urinary obstruction, or difficulty in voiding at screening\n    * Evidence of congenital renal abnormalities with known effect on renal function\n    * Calculated eGFR \\\u003C 60 mL\u002Fmin\n13. Hematology parameters at screening:\n\n    * Hemoglobin: \\\u003C 10 g\u002FdL\n    * Platelets: \\\u003C 100,000\u002Fmm3\n    * Leucocytes: \\\u003C 3,000\u002Fmm3\n    * Neutrophils:\\\u003C 1,500\u002Fmm3\n14. History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)\u002F Alanine Aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at screening\n15. Use of other investigational drugs s within 5 half-lives or within 30 days (for small molecules) prior to Screening or until the expected pharmacodynamic (PD) effect has returned to baseline (for biologics), whichever is longer; or longer if required by local regulations\n16. Contraindications to or hypersensitivity to remibrutinib (or its excipients or to drugs of similar chemical classes) or other substances provided to the subjects as rescue medication to control symptoms, such as antihistamines.\n17. Participants taking prohibited therapies as listed in Section 6.6.2. In particular patients with pretreatment with remibrutinib or another BTK-inhibitor within 4 months prior to randomization.\n18. History of live or live attenuated vaccine within 6 weeks prior to randomization or requirement to receive these vaccinations at any time during the study drug treatment.\n19. Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg\u002Fd or clopidogrel up to 75 mg\u002Fd which are allowed. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited.\n20. Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants (NOAC)).\n21. History of gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion)\n22. Significant bleeding risk or coagulation disorders.\n23. Known history or evidence of ongoing alcohol or drug abuse within the last 6 months before randomization as per source records.\n24. Pregnant or nursing (breast feeding) women.\n25. Women of child-bearing potential, defined as fertile, following menarche and until becoming post-menopausal unless they are permanent sterile or they are using highly effective methods of contraception during dosing for 7 days after stopping study treatment. Highly effective contraception methods include:\n\n    * Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n    * Bilateral oophorectomy with or without hysterectomy, total hysterectomy or bilateral salpingectomy at least six weeks prior to the first dose of study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered to be not of child-bearing potential.\n    * Bilateral tubal occlusion, Bilateral tubal ligation (at least six weeks prior to the first dose of study treatment)\n    * Male partner sterilization (vasectomy) of male partner(s) of the female participant at least six months prior to screening). The vasectomized male partner should be sole partner for that participant and received medical assessment of the surgical success.\n    * Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example hormone vaginal ring or transdermal hormone contraception.\n\nThe decision on the contraceptive method should be reviewed at least every 3 months to evaluate the individual need and compatibility of the method chosen. In case of use of hormonal contraception, women should have been stable on the same method for a minimum of 3 months before taking study treatment. Women are considered post-menopausal if they have no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n\nWomen are considered not of child-bearing potential if they are post-menopausal or permanently sterileor have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks prior to first dose of study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child-bearing potential.\n\nIf local regulations are more stringent than the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF.",{"count":563,"type":22},44,[25],"The purpose of this study is to explore the effect and Mechanism of Action (MoA) of remibrutinib (LOU064) vs. placebo on clinical outcomes in participants with Chronic Urticaria (CU), including both Chronic Spontaneous Urticaria (CSU) and Chronic Inducible Urticaria (CINDU).",[567],"Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)",[300,569,570,571,572,573,574,575,576,577,578,579,580],"LOU064","Chronic urticaria","CINDU","CSU","Symptomatic dermographism","Cold urticaria","Cholinergic urticaria","Heat urticaria","Solar urticaria","Delayed pressure urticaria","Aquagenic urticaria","Contact urticaria",{"date":280,"type":41},{"date":583,"type":41},"2025-05-22",{"date":585,"type":22},"2027-09-28",{"name":47,"class":48},{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":594,"enrollmentInfo":595,"targetDuration":4,"studyType":23,"phases":597,"briefSummary":598,"conditions":599,"keywords":601,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":612},"100566493","phase-2-phase-2-study-evaluating-rapcabtagene-autoleucel-in-participants-with-diffuse-cutaneous-systemic-sclerosis-100566493","NCT06655896","Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis","A Phase II, Multi-part, Randomized, Open-label, Assessor-blinded, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Rituximab Treatment in Participants With Severe Refractory Diffuse Cutaneous Systemic Sclerosis","Inclusion Criteria:\n\n1. Participant must fulfill the 2013 American College of Rheumatology\u002F European League Against Rheumatism classification criteria for systemic sclerosis and meet the diffuse cutaneous SSc (dcSSc) subset classification according to LeRoy.\n2. Disease onset from the first non-Raynaud symptoms attributable to SSc (e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea) within 7 years prior to the Screening visit.\n3. Severe, progressive systemic sclerosis disease defined by at least one of the following:\n\n   * Progressive systemic sclerosis-associated interstitial lung disease\n   * Severe, progressive systemic sclerosis skin disease\n   * Clinically significant systemic sclerosis-associated cardiac involvement at Screening\n4. All recommended vaccinations received according to institutional, local or global guidelines for immuno-compromised patients.\n\nExclusion Criteria:\n\n1. Any condition during Screening that could prevent a complete washout of medications as required per protocol or could otherwise make the participant ineligible for anti-CD19 CAR-T therapy and further participation in the study, as judged by the Investigator.\n2. Participants with history of hypersensitivity to excipients in rapcabtagene autoleucel or to rituximab.\n3. Any participant for whom treatment with rituximab is clinically inappropriate in the opinion of the investigator.\n4. Any medical conditions that are not related to SSc that, in the opinion of the Investigator, would jeopardize the ability of the participant to tolerate lymphodepletion and anti-CD19 CAR-T cell therapy.\n5. Rheumatic disease other than dcSSc, (except secondary Sjogren's syndrome or scleroderma myopathy),including limited cutaneous systemic sclerosis (lcSSc) or sine scleroderma at Screening.\n6. Participants with pre-existing pulmonary hypertension.\n7. Significant renal pathology at Screening.\n8. Participants with uncontrolled stage II hypertension at Screening.\n9. Vaccination with live attenuated vaccines within 6 weeks prior to randomization.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","70 Years",{"count":596,"type":22},96,[25],"The purpose of this study is to evaluate the efficacy, safety and tolerability of rapcabtagene autoleucel (administered once following lymphodepletion) in participants with severe refractory diffuse cutaneous systemic sclerosis relative to rituximab.",[600],"Scleroderma, Diffuse",[602,600,603,604,605],"Diffuse cutaneous systemic sclerosis (dcSSc)","revised Composite Response Index in Systemic Sclerosis (rCRISS)","modified Rodnan skin score (mRSS)","forced vital capacity (FVC)",{"date":280,"type":41},{"date":608,"type":41},"2024-10-29",{"date":610,"type":22},"2032-08-30",{"name":47,"class":48},94,{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":4,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":620,"enrollmentInfo":621,"targetDuration":4,"studyType":23,"phases":623,"briefSummary":624,"conditions":625,"keywords":627,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":635,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":640,"locationsCount":641},"100564701","phase-2-a-study-of-efficacy-safety-tolerability-of-lxe408-in-participants-with-chronic-chagas-disease-100564701","NCT06632600","A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.","A Randomized, Participant- and Investigator-blinded, Controlled, Parallel Group Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LXE408 in Participants With Chronic Chagas Disease Without Severe Organ Dysfunction.","Inclusion Criteria:\n\n* Male or female participants aged ≥ 18 years to ≤ 60 years old\n* Confirmed diagnosis of T. cruzi infection\n* History that participant has been determined to be in chronic phase of CD\n* Written informed consent must be obtained before any assessment is performed, and participants should express understanding of the consent form and the study\n* Participants must be considered by the investigator eligible for and able to comply with local prescribing information for benznidazole\n* Ability and willingness to communicate well with the investigator\u002Fstudy site and comply with requirements of the study\n\nExclusion Criteria:\n\n* Signs (on physical examination) and\u002For symptoms of CD in the acute phase as determined by the investigator at screening\n* History of CD treatment with benznidazole or nifurtimox at any time in the past\n* History of and\u002For current (at screening) symptoms or signs (physical examination findings) of moderate or severe CD-related gastrointestinal disease\n* Participants who weigh \\\u003C 50 kg or \\>90kg at screening\n* At sites conducting the MRI assessments, participants may participate in the overall study, but will be excluded from the MRI assessment if they have contraindications to MRI imaging\n* Any clinically significant disease during screening that, in the opinion of the investigator, would put the safety of the participant at risk through participating, or which would affect the efficacy or safety analysis if the disease\u002Fcondition exacerbated during the study, or would compromise participant compliance or preclude completion of the study\n* Documented history or current findings at screening of clinically significant cardiovascular conditions such as, but not limited to: unstable ischemic heart disease; NYHA Class III\u002FIV heart failure (due to Chagas disease or other conditions); arrhythmias\n* Known or suspected ongoing, chronic or recurrent viral, bacterial or fungal infectious diseases including but not limited to: Tuberculosis, leishmaniasis, severe malaria, atypical mycobacterial infection, listeriosis, aspergillosis, or endemic mycoses, and\u002For documented positivity for human immunodeficiency virus (HIV) infection.\n\n  * Participants with controlled HIV on antiretroviral therapy are eligible to participate if CD4 ≥ 500 at screening\n* History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years prior to screening (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed)\n* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the participant during the study period\n\n  * Pancreatic injury or pancreatitis: If any single parameter of amylase or lipase exceeds 1.5x ULN at screening Participants with known recurrent pancreatitis (more than 1 episode in lifetime, from any cause) are excluded\n  * Liver disease or liver injury as indicated by abnormal liver function tests (LFTs):\n\nAny single parameter of ALT, AST, alkaline phosphatase must not exceed 1.5x ULN at screening Serum bilirubin must not exceed the ULN at screening elevated serum bilirubin is not excluded if there is a documented history of Gilbert's Syndrome\n\n* History of renal disease as indicated by creatinine level above 1.5x ULN or microalbuminuria at screening; Evidence of urinary obstruction, or difficulty in voiding at screening; evidence of congenital renal abnormalities with known effect on renal function; calculated eGFR \\\u003C60 mL\u002Fmin (\\\u003C0.835 mL\u002Fs) using the CKD-EPI formula for adults\n\n  * Participants with screening hematology parameters outside of the thresholds\n  * Current use of medications prohibited by the protocol at screening and\u002For baseline visits, or expected use of any prohibited medication during the study treatment period\n* Use of benznidazole in the blinded arms is prohibited until unblinding occurs after all participants complete Month 12.\n\n  * Use of other investigational drugs at the time of study drug dosing\n  * History of multiple and recurring allergies or allergy to the investigational compound\u002Fcompound class being used in this study or to benznidazole\n  * History of drug abuse or unhealthy alcohol use within the 12 months prior to dosing\n  * Pregnant or nursing (lactating\u002Fbreast-feeding) women\n  * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 5 days after stopping of investigational drug and benznidazole\n  * Participants who, in the opinion of the investigator, will not be able to comply with study procedures or visits, adhere to dosing schedule, or other otherwise be in compliance with study requirements\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","60 Years",{"count":622,"type":22},130,[25],"This study is to investigate the ability of LXE408 to clear or reduce the level of parasites in the blood of people with chronic Chagas disease. Participants must have chronic Chagas disease without severe organ dysfunction.",[626],"Chagas Disease",[628,629,630,631,632,633,634],"LXE408","Chronic Chagas disease","Chronic indeterminate Chagas disease","Chronic Chagas disease without severe organ dysfunction","CICD","Chronic CD","Trypanosoma cruzi",{"date":280,"type":41},{"date":637,"type":41},"2025-04-28",{"date":639,"type":22},"2031-01-21",{"name":47,"class":48},21,{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":4,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":594,"enrollmentInfo":649,"targetDuration":4,"studyType":23,"phases":651,"briefSummary":652,"conditions":653,"keywords":655,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":666,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":671,"locationsCount":672},"100552204","phase-2-a-clinical-study-to-evaluate-ianalumab-in-participants-with-diffuse-cutaneous-systemic-sclerosis-100552204","NCT06470048","A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis","A Randomized, Double-blind, Parallel Group, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety and Tolerability of Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis","Key Inclusion Criteria:\n\n* Male and female participants \\>= 18 and =\\\u003C 70 years (at the time of the screening visit).\n* Diagnosis of systemic sclerosis, as defined by the 2013 American College of Rheumatology\u002F European League Against Rheumatism (ACR\u002FEULAR) classification criteria for SSc (van den Hoogen et al 2013) and meet the dcSSc subset classification according to LeRoy (LeRoy 1988)\n* Disease duration of =\\\u003C 60 months (defined as time from the first non-Raynaud phenomenon manifestation, e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea)\n* mRSS units of \\>= 15 and =\\\u003C 45 at the time of the screening visit\n* Active disease that meets at least one of the following criteria at screening:\n\n  * Disease duration of =\\\u003C 18 months defined as time from the first non-Raynaud phenomenon manifestation\n  * Increase in mRSS of \\>= 3 units compared with the most recent assessment performed within the previous 6 months\n  * Involvement of one new body area and an increase in mRSS of \\>= 2 units compared with the most recent assessment performed within the previous 6 months\n  * Involvement of two new body areas within the previous 6 months\n  * Elevated acute phase reactants (ESR) \\>= 30 mm\u002Fhr or high-sensitivity C-reactive protein (hsCRP) \\>= 6 mg\u002FL)\n  * Presence of SSc-interstitial lung disease (ILD) and ATA autoantibody positivity\n  * Modified EUSTAR disease activity index (mDAI) ≥ 2.5\n* Participant must be positive for at least one of the following autoantibodies:\n\n  * anti-topoisomerase I (ATA) (also known as anti-SCL-70)\n  * anti-RNA polymerase III (anti-RNAP3)\n  * anti-nuclear antibody (ANA) (≥ 1:80) Participants who are positive only for ANA (while being negative for both ATA \u002Fanti-RNAP3) will be limited to 30% of the overall randomized study population.\n\nKey Exclusion Criteria:\n\n* Rheumatic disease other than dcSSc, including limited cutaneous disease (lcSSc) or sine scleroderma at the screening visit. Secondary Sjogren's disease and scleroderma myopathy are not exclusionary.\n* Positive anti-centromere antibody (ACA+) without positive ATA or anti-RNAP3 autoantibody result at the screening visit\n* Previous improvement (decrease) in mRSS \\> 10 units\n* Pulmonary disease with FVC ≤ 50% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO, corrected for hemoglobin) ≤ 40% of predicted at the screening visit\n* WHO Functional Class 3 or higher assessment for pulmonary arterial hypertension (PAH, as defined on right heart catheterization), receiving IV therapy for PAH or evidence of other moderately severe pulmonary disease\n* Participants treated with cyclophosphamide within 12 weeks prior to Baseline.\n* Prior use of a B-cell depleting therapy other than ianalumab (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) administered within 36 weeks prior to randomization, or as long as B cell count is less than the lower limit of normal or baseline value prior to receipt of B cell-depleting therapy (whichever is lower).\n* Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal antibodies, including marketed drugs, within 12 weeks or 5 half-lives (whichever is longer) prior to baseline visit, unless explicitly allowed in inclusion criteria.\n* Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit.\n* Use of anti-fibrotic agents including colchicine, D-penicillamine, pirfenidone, or tyrosine kinase inhibitors (e.g., nintedanib, nilotinib, imatinib, dasatinib) in the 4 weeks prior to baseline visit. Patients with SSc-ILD requiring antifibrotics for management of ILD during the study, as per investigator judgement, should be excluded.\n* Previous treatment with chlorambucil, bone marrow transplantation or total lymphoid irradiation.\n* Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate \\\u003C 1% per year) while taking study treatment and for 6 months after stopping study treatment.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":650,"type":22},200,[25],"The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo",[654],"Diffuse Cutaneous Systemic Sclerosis",[656,657,658,600,659,660,661,662,663,664,665],"Diffuse Cutaneous Systemic Sclerosis (dcSSc)","Diffuse Scleroderma","Diffuse Systemic Sclerosis","Scleroderma, Progressive","Sclerosis, Progressive Systemic","Sudden Onset Scleroderma","B cell depletion","Revised Composite Response Index in Systemic Sclerosis 25 (rCRISS25)","modified Rodnan skin score","forced vital capacity",{"date":280,"type":41},{"date":668,"type":41},"2024-10-09",{"date":670,"type":22},"2034-07-31",{"name":47,"class":48},128,{"id":674,"slug":675,"hasResults":12,"nctId":676,"briefTitle":677,"officialTitle":678,"acronym":679,"eligibilityCriteria":680,"healthyVolunteers":12,"sex":18,"minAge":144,"maxAge":145,"enrollmentInfo":681,"targetDuration":4,"studyType":23,"phases":683,"briefSummary":684,"conditions":685,"keywords":687,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":701,"startDateStruct":702,"completionDateStruct":704,"leadSponsor":706,"locationsCount":707},"100549825","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-crizanlizumab-5-mgkg-compared-with-placebo-in-adolescent-and-adult-sickle-cell-disease-patients-who-experience-frequent-vaso-occlusive-crises-sparkle-100549825","NCT06439082","A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg\u002Fkg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)","A Phase III, Multicenter, Randomized, Placebo Controlled, Double-blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg\u002Fkg) Versus Placebo, With or Without Hydroxyurea\u002FHydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients With Frequent Vaso-Occlusive Crises","SPARKLE","Key Inclusion Criteria:\n\n1. Participants must be aged 12 years and older on the day of signing informed consent. Adolescents include participants aged 12 to \\\u003C18 years old and adults include participants aged 18 years and older.\n2. Confirmed diagnosis of SCD by Hb electrophoresis or high-performance liquid chromatography (HPLC) (performed locally or by central laboratory if not available locally). All SCD genotypes are eligible.\n3. Experienced 4 to 12 VOCs (refer to Section 8.3.1 for study definition of VOC) that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to the screening visit. Baseline VOCs are determined by medical history and are required to be documented at source.\n4. If the participant is on HU\u002FHC, they must be taking it for at least 6 months and at stable dose for at least 3 months prior to the Screening visit and plan to continue taking it at the same dose and schedule until at least the participant has reached 52 weeks of the planned study treatment. Participants who have initiated HU\u002FHC 6-12 months prior to the screening visit must have evidence of insufficient control of acute pain despite initiation. These participants must have a cumulative of 4-12 VOCs in the 12 months prior to the screening period, with at least 2 during the last 6 months while on HU\u002FHC. If receiving erythropoietin stimulating agent, the participant must have been receiving the drug for at least 6 months prior to screening visit and plan to continue taking the drug at the same dose and schedule until the participant has reached 52 weeks of the planned study treatment.\n\nParticipants who have not been receiving HU\u002FHC, and\u002For erythropoietin stimulating agent must not have received it for at least 6 months prior to screening visit.\n\nKey Exclusion Criteria:\n\n1. Fewer than 4 or more than 12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to screening visit as determined by medical history and documented at source.\n2. History of stem cell transplant and\u002For gene therapy.\n3. Received blood products within 30 days prior to Week 1 Day 1 dosing.\n4. Any documented history of a clinical stroke or intracranial hemorrhage, or an uninvestigated neurologic finding within the past 12 months before screening visit. Silent infarct only present on imaging is not excluded.\n5. Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and\u002For planning to undergo an exchange transfusion during the duration of the study; episodic transfusion in response to worsened anemia or VOC is permitted.\n6. Contraindication or hypersensitivity to any drug or metabolites from similar class as study drug or to any excipients of the study drug formulation. History of severe hypersensitivity reaction to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.",{"count":682,"type":22},354,[61],"A phase III, multi-center, randomized, placebo-controlled, double-blind study to assess efficacy and safety of crizanlizumab (5 mg\u002Fkg) versus placebo, with or without hydroxyurea\u002Fhydroxycarbamide therapy, in adolescent and adult Sickle Cell Disease patients with frequent vaso-occlusive crises.",[686],"Sickle Cell Disease",[686,688,689,690,691,692,693,694,695,696,697,698,699,700],"SCD","SEG101","Crizanlizumab","Hydroxyurea\u002F Hydroxycarbamide Therapy","Vaso-Occlusive Crises","Sickle Cell Anemia","blood disorders","hemoglobin","red blood cells","sickle-like shape","mutation in hemoglobin gene","sickle-cell trait","sickle-cell crisis",{"date":280,"type":41},{"date":703,"type":41},"2024-10-24",{"date":705,"type":22},"2030-07-29",{"name":47,"class":48},34,{"id":709,"slug":710,"hasResults":12,"nctId":711,"briefTitle":712,"officialTitle":713,"acronym":4,"eligibilityCriteria":714,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":620,"enrollmentInfo":715,"targetDuration":4,"studyType":23,"phases":717,"briefSummary":718,"conditions":719,"keywords":721,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":723,"startDateStruct":724,"completionDateStruct":726,"leadSponsor":728,"locationsCount":729},"100516595","phase-2-a-study-to-assess-the-efficacy-safety-and-pharmacokinetics-of-eyu688-in-patients-with-dengue-fever-100516595","NCT06006559","A Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever","A Randomized, Participant- and Investigator-blinded, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever","Inclusion Criteria:\n\n* Male or female, 18 - 60 years old (inclusive).\n* History or presence of fever (≥ 38°C). At least one of the following criteria indicating dengue infection:\n* Nausea or vomiting.\n* Presence of rash, aches or pains including headache, muscle or joint pain.\n* Onset of fever ≤ 48 hours prior to treatment start.\n* Positive test on dengue fever.\n\nExclusion Criteria:\n\n* Participants with any of abnormalities of clinical laboratory parameters.\n* Usage of any anticoagulant drugs.\n* Current significant medical conditions or illness that the investigator considers should exclude the participants, especially those that require continuation of other medications likely to have an interaction with the study drug.\n* Pregnant or nursing (lactating) women.\n* Clinical signs and symptoms for severe dengue according to Dengue Guideline (WHO 2009) at screening.\n* Participants with any of the following abnormalities of clinical laboratory parameters at screening:\n\n  * Hemoglobin \\\u003C12.0 g\u002FdL in males; \\\u003C11.0 g\u002FdL in females\n  * Hematocrit \\>52 % in males; \\>46 % in females\n  * Absolute neutrophil count \\\u003C1500\u002FμL\n  * Platelet count \\\u003C80,000\u002Fmm3\n  * Creatinine \\>165 μmol\u002FL in males; \\>130 μmol\u002FL in females\n  * Serum creatine kinase \\> 600 U\u002FL\n  * ALT, AST levels more than 3 X upper limit of normal (ULN)\n  * Total bilirubin \\>24 μmol\u002FL\n* Usage of PPIs (proton pump inhibitor) which could affect absorption of EYU688 due to stomach pH value increase up to 48 hours prior to screening.\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 4 days after stopping of investigational drug.\n* History or long-QT syndrome, or clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening:\n\n  * QTcF \\> 450 msec (males)\n  * QTcF \\> 460 msec (females)\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":716,"type":22},108,[25],"The purpose of this study is to characterize the effect on dengue viral load, fever clearance time as well as on clinical signs and symptoms with the treatment of EYU688 compared with placebo in patients with dengue fever.",[720],"Dengue",[720,722],"EYU688",{"date":280,"type":41},{"date":725,"type":41},"2024-02-20",{"date":727,"type":22},"2027-07-30",{"name":47,"class":48},27,""]