[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Lithuania\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":639},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,148,0,25,[9,42,71,98,125,152,177,201,223,250,271,292,313,336,363,386,407,429,450,474,506,527,552,584,611],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100615931","a-study-of-orelabrutinib-in-patients-with-secondary-progressive-multiple-sclerosis-100615931",false,"NCT07299019","A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis","A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary Progressive Multiple Sclerosis","Inclusion Criteria:\n\n1. 18 to 60 years of age, inclusive, at the time of signing the informed consent.\n2. Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria\n3. Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013\n4. Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before screening. A written summary of the clinical evidence of disability progression must be discussed and aligned between the Investigator and the Sponsor's dedicated qualified person(s).\n5. Absence of clinical relapses for at least 24 months.\n\nExclusion Criteria:\n\n1. The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria\n2. Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy.\n3. History or current diagnosis of other neurological disorders that may mimic MS\n4. History or current diagnosis of progressive multifocal leukoencephalopathy\n5. Active, clinically significant viral, bacterial, or fungal infection\n6. History of any other significant active medical condition\n7. History of suicidal behavior within 6 months prior to Screening\n8. Any prior history of malignancy\n9. Patients on anticoagulation, or antiplatelet therapy\n10. Patients took strong\u002Fmoderate CYP3A inhibitors or strong\u002Fmoderate CYP3A inducers within 14 days\n11. Clinically significant laboratory abnormalities at Screening.\n12. Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening\n13. History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.","ALL","18 Years","60 Years",{"count":21,"type":22},990,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.",[28],"Secondary Progressive Multiple Sclerosis","RECRUITING","2026-08-21",{"date":32,"type":33},"2026-08-25","ACTUAL",{"date":35,"type":33},"2026-03-23",{"date":37,"type":22},"2030-07",{"name":39,"class":40},"Zenas BioPharma (USA), LLC","INDUSTRY",37,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100611500","phase-3-a-study-of-orforglipron-ly3502970-on-cardiovascular-outcomes-in-adults-with-atherosclerotic-cardiovascular-disease-andor-chronic-kidney-disease-attain-outcomes-100611500","NCT07241390","A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease (ATTAIN-Outcomes)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease","Inclusion Criteria:\n\n* Have established ASCVD and\u002For CKD\n\nExclusion Criteria:\n\n* Have type 1 diabetes\n* Have had a major heart condition within 60 days prior to screening\n* Have New York Heart Association Functional Classification Class IV heart failure","50 Years",{"count":51,"type":22},7140,[25],"The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and\u002For chronic kidney disease (CKD). Participation in the study will last about 5 years.",[55,56],"Atherosclerosis Cardiovascular Disease","Chronic Kidney Disease",[58,59,60,61],"Heart Disease","Kidney Disease","Outcomes","Stroke",{"date":63,"type":33},"2026-08-24",{"date":65,"type":33},"2025-12-01",{"date":67,"type":22},"2031-08",{"name":69,"class":40},"Eli Lilly and Company",567,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100593896","phase-2-a-study-of-long-acting-antibodies-alone-and-in-combinations-for-moderate-to-severe-ulcerative-colitis-100593896","NCT07012395","A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis","Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis","SKYLINE-UC","Inclusion Criteria:\n\n* Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening\n* Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)\n* Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2\n\nExclusion Criteria:\n\n* Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined\n* Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and\u002For other conditions that will likely require surgery during induction\n* Failed 4 or more approved or investigational advanced therapy classes","75 Years",{"count":81,"type":22},645,[83],"PHASE2","This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.",[86,87,88,89],"Ulcerative Colitis","Inflammatory Bowel Diseases","Colitis","Colitis, Ulcerative",{"date":32,"type":33},{"date":92,"type":33},"2025-05-27",{"date":94,"type":22},"2028-03",{"name":96,"class":40},"Spyre Therapeutics, Inc.",267,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100587610","phase-3-a-study-to-assess-the-efficacy-and-safety-of-debio-4126-in-participants-with-acromegaly-previously-treated-with-somatostatin-analogs-100587610","NCT06930625","A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs","A Phase 3 Randomized 3-arm Trial (Double-blind Debio 4126, Placebo Control, and Open-label Debio 4126), to Assess the Efficacy and Safety of Debio 4126, a 12-week Octreotide Formulation, in Patients With Acromegaly Previously Treated With Somatostatin Analogs","OXTEND™-03","Inclusion criteria\n\n1. Patients ≥18 years of age\n2. Patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks.\n3. IGF-1 at screening ≤1x ULN\n4. Acromegaly diagnosis, defined as per protocol\n5. Adequate bone marrow, hepatic and renal function\n6. To enter Period 2 (Arms A and B): IGF-1 ≤1x ULN at Week 34, or up to Week 48 when treated with rescue medication\n7. Other protocol-defined criteria apply\n\nExclusion criteria\n\n1. Compression of optic chiasm causing visual defects\n2. Symptomatic cholelithiasis or bile duct dilatation\n3. Planned cholecystectomy during the trial duration\n4. Acute or chronic pancreatitis\n5. Pituitary radiotherapy\n6. Uncontrolled hypothyroidism\n7. Uncontrolled diabetes\n8. Pituitary surgery within 6 months before screening or planned on trial\n9. Treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamine agonists within 3 months prior to screening\n10. Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism\n11. Other protocol-defined criteria apply",{"count":107,"type":22},119,[25],"The primary purpose of this study is to assess the effect of Debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (IGF-1) ≤1x upper limit of normal (ULN) in the double-blind period (Period 1) in comparison to placebo at week 36.",[111],"Acromegaly",[113,114,115,116],"IGF-1","Growth hormone","Pituitary gland","Gigantism",{"date":63,"type":33},{"date":119,"type":33},"2025-11-26",{"date":121,"type":22},"2029-03",{"name":123,"class":40},"Debiopharm International SA",73,{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":135,"conditions":136,"keywords":139,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100323125","phase-3-long-term-safety-and-efficacy-extension-study-for-participants-with-advanced-tumors-who-are-currently-on-treatment-or-in-follow-up-in-a-pembrolizumab-mk-3475-study-mk-3475-587keynote-587-100323125","NCT03486873","Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587\u002FKEYNOTE-587)","A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab","Inclusion Criteria:\n\n* Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.\n* Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.\n\nAdditional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:\n\n* Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Demonstrates adequate organ function.\n* Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of \\>30 Gray (Gy), they must have recovered from the toxicity and\u002For complications of the intervention.\n* A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.\n\nAdditional eligibility criteria for participants who enter dosing with Lenvatinib:\n\n* Adequately controlled blood pressure (BP) to \\\u003C150\u002F90 mmHg, with or without antihypertensive medications.\n* For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.\n* Is female and not pregnant\u002Fbreastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.\n\nExclusion Criteria:\n\n-There are no exclusion criteria to participate in MK-3475-587.\n\nParticipants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:\n\n* Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.\n* Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has a known history of human immunodeficiency virus (HIV) infection.\n* Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.\n* Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.\n* Has hepatic decompensation (Child-Pugh score \\>6 \\[class B and C\\]).\n* Has uncontrolled thyroid dysfunction.\n* Has uncontrolled diabetes mellitus.\n* Has had an allogeneic tissue\u002Fsolid organ transplant.\n* Has a known history of active tuberculosis (TB; Bacillus tuberculosis).\n\nAdditional exclusion criteria for participants who enter dosing with Lenvatinib:\n\n* Has had major surgery within 3 weeks prior to first dose of study intervention(s).\n* Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.\n* Has urine protein ≥1 g\u002F24 hours.\n* Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).\n* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.\n* Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \\>480 ms.\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.\n* Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.\n* Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.\n* Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.",{"count":133,"type":22},3500,[25],"The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.\n\nThis study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.\n\nAny participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.",[137,138],"Solid Tumors","Hematologic Malignancies",[140,141,142,143],"PD1","PD-1","PDL1","PD-L1",{"date":32,"type":33},{"date":146,"type":33},"2018-08-21",{"date":148,"type":22},"2043-08-04",{"name":150,"class":40},"Merck Sharp & Dohme LLC",782,{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":23,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},"100624854","phase-2-ly4268989-in-adults-with-moderately-to-severely-active-ulcerative-colitis-100624854","NCT07415044","LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis","A Randomized, Multicenter, Double-Blind, Placebo-Controlled Development Program to Evaluate the Efficacy and Safety of LY4268989 (MORF-057) for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-3)","EMERALD-3","Inclusion Criteria:\n\n* Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC\n* Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by central reader and rectal bleeding (RB)≥1\n* Have evidence of UC extending proximal to the rectum\n* Have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization, if the participant has a history of UC symptoms for more than 8 years\n* Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators). Participants with inadequate response to vedolizumab are excluded\n* Must meet contraception requirements\n\nExclusion Criteria:\n\n* Have a current diagnosis of\n\n  * Crohn's disease\n  * Inflammatory Bowel Disease (IBD unclassified) (formerly known as indeterminate colitis), or\n  * primary sclerosing cholangitis\n* Have an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation\n* Have had or will need bowel resection or intestinal or intra-abdominal surgery\n* Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic\n* Have any prior or current evidence of cancer gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancies\n* Have a diagnosis or history of malignant disease within 5 years prior to randomization","80 Years",{"count":162,"type":22},1431,[83],"The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally.\n\nThe study will last up to approximately 108 weeks, excluding screening.",[166,167,168],"Ulcerative Colitis (UC)","Ulcerative Colitis, Active Moderate","Ulcerative Colitis, Active Severe","2026-08-20",{"date":30,"type":33},{"date":172,"type":33},"2026-03-26",{"date":174,"type":22},"2031-07",{"name":69,"class":40},259,{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":17,"minAge":185,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":23,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":200},"100607359","phase-2-safety-and-efficacy-of-human-anti-thymocyte-immunoglobulin-sab-142-arresting-progression-of-type-1-diabetes-100607359","NCT07187531","SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes","A Phase 2b, Randomised, Double-Blind, Placebo-Controlled, Parallel-Arm Dose Finding Study Evaluating the Efficacy and Safety of SAB-142 for Delaying the Progression of Type 1 Diabetes (T1D) in Patients With Stage 3 New Onset of Type 1 Diabetes (NOT1D)","SAFEGUARD","Inclusion Criteria:\n\n1. Participant and\u002For appropriate legal guardian for participants below the legal age of consent must have given written informed consent and\u002For assent according to local, regional and\u002For country specific guidance before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. Participants and legal guardians must be capable of providing informed consent and not be incapacitated.\n2. Males and females 15-40 years old at the time of randomisation in Part A. Males and females 5-40 years old\\*, inclusive, at the time of randomisation in Part B.\n3. Weight ≥16.0 kg at time of randomisation. Participants age 18-40 will have a body mass index (BMI) from 16 to 32 (inclusive).\n4. Participant has received a diagnosis of T1D according to American Diabetes Association criteria within 100 days of randomization. For participants who were initially misdiagnosed with Type 2 diabetes, time from misdiagnosis with Type 2 diabetes to randomization is 100 days. Note: Unless previously diagnosed with preclinical (Stage 1 or Stage 2 T1D), participant must have initiated insulin therapy by the time of randomisation. An extension of no more than 14 days is permitted if a participant has planned and\u002For is required to receive a vaccination within 30 days prior to randomisation or is completing the 10 day CGM period.\n5. Participant has random C-peptide levels of ≥0.2 nmol\u002FL, measured during Screening. One random C-peptide retest during screening period is allowed.\n6. Participant completed all scheduled samples for C-peptide collected during the MMTT test during Screening.\n7. Participant has a positive result on testing for at least one of the following T1D-related autoantibodies during screening:\n\n   * Glutamic acid decarboxylase 65 (GAD65)\n   * Islet antigen 2 (IA-2)\n   * Zinc transporter 8 (ZnT8)\n   * Insulin autoantibodies (if testing within the first 14 days of insulin treatment)\n8. Female participants:\n\n   a. Must be of nonchildbearing potential, i.e., pre-pubertal\\*, surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening, or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle stimulating hormone (FSH) level consistent with postmenopausal status, per local laboratory guidelines), or b. If of childbearing potential, must: i. Have a negative result on a serum (beta human chorionic gonadotropin \\[β-HCG\\]) at screening and a negative urine β-HCG pregnancy test prior to study drug administration on Day 1 of both treatment periods.\n\n   ii. Agree not to become pregnant or donate ova from the time of signing the consent form until the end of study visit.\n\n   iii. If not exclusively in a same-sex relationship or abstinent as a committed lifestyle, must agree to use adequate contraception (which is defined as use of a condom by the male partner combined with use of a highly effective method of contraception from the time of signing the consent and for the duration of the study.\n\n   \\* Note: Female participants will be considered to be pre-pubertal (and of nonchildbearing potential) if they have not yet started menstruation. This should also be verified by the parent(s)\u002Fguardian(s). If a female participant reaches menarche during the study, then she is to be considered as a woman of childbearing potential from that time forwards, and contraceptive requirements will apply.\n9. Male participants, if not biologically or surgically sterilised, must:\n\n   1. Agree not to donate sperm from the time of signing the consent form until EOS.\n   2. If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception from time of signing the consent form until EOS.\n   3. If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from signing the consent form until EOS.\n10. Prior to receiving study drug, participant must agree to receive locally, regionally and\u002For country-specific required age-appropriate immunisations. Participants are advised but not required to comply with the guidelines for immunosuppressed individuals and those with chronic disease (diabetes mellitus) according to current local, regional and\u002For country- specific guidelines. Note: Vaccines are permitted within the timeframes specified in exclusion criterion #17.\n11. Participant agrees not to receive other forms of experimental treatment from the time of signing informed consent and for the duration of the study, particularly agents that may be immune modulatory in nature and\u002For stimulate pancreatic β cell regeneration or insulin secretion.\n12. Participant has suitable venous access for blood sampling.\n13. Participant is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.\n14. Part C: Participant has completed Month 12 assessments for Part A and Part B and meets all applicable eligibility requirements for participation in Part C.\n\nExclusion Criteria:\n\n1. Participant has known allergy, hypersensitivity or moderate to severe allergic reaction including anaphylaxis to natural or recombinant antibodies, biologic treatments, passive vaccines, pork, or any other component of the study drug formulation (including biologic medications). This includes participants with Hereditary Fructose Intolerance.\n2. Participant has a known allergy or hypersensitivity to any of the protocol-required concomitant medications.\n3. Participant has been an active participant in a therapeutic drug, invasive medical device, or vaccine clinical trial within 12 weeks before Screening Visit (SV) 2 (Parts A and B) or 28 days prior to Day 1, TP3 (Part C)\n4. Participant has received teplizumab or any investigational immunomodulatory anti-CD3 treatment within any timeframe prior to screening.\n5. Participant has a significant uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, neurologic, haematologic, rheumatologic, oncologic, psychiatric, or immune deficiency that may interfere with the participant's safely participating in the study or with interpretation of the safety and\u002For efficacy profile of investigational medicinal product (IMP). For any disorders, a participant with a stable, well-controlled condition that is not felt to interfere with study participation may be enrolled.\n6. Participant has any autoimmune disease other than T1D (e.g., rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythaematous) that is currently managed with systemic immunotherapy, with the exception of clinically stable thyroid or celiac disease.\n7. Participant is prone to infections, or has chronic, recurrent or opportunistic infectious disease, including but not limited to renal, respiratory or skin infections, Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis.\n8. Participant has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV)-1 or 2, hepatitis B virus (HBV), or hepatitis C virus (HCV) antibodies.\n9. Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and\u002For TB testing. Note: Blood testing (e.g., QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.\n10. Serious systemic viral, bacterial, or fungal infection (e.g., pneumonia, pyelonephritis), infection requiring hospitalization or IV anti-infective treatments or significant acute or chronic viral (including history of recurrent or active herpes zoster, acute or active cytomegalovirus \\[CMV\\], Epstein-Barr Virus \\[EBV\\] as determined at screening), bacterial, or fungal infection (e.g., osteomyelitis) 30 days before and during screening. Note: Participants with confirmed active EBV or CMV infection based on polymerase chain reaction (PCR) test can be retested; asymptomatic participants with the most recent PCR-negative test are eligible for participation. Participants with an active mild infection at Screening may be enrolled once the symptoms have resolved and all I\u002FE are met. Participants who have an active infection and\u002For fever ≥38.0°C (100.4°F) within the 48 hours prior to dose administration should not be dosed.\n11. Participant has a diagnosis of significant liver disease or at screening ALT and\u002For AST \\>2× or total bilirubin of \\>1.5× of the age- and sex-specific upper limit of normal (ULN) according to the central laboratory and confirmed by repeated tests. Liver function tests can be repeated during screening and if normalised, participant maybe eligible for randomization. Note: Participants with Gilbert's syndrome are allowed to enroll if only total and\u002For indirect bilirubin are elevated above ULN while ALT, AST, and alkaline phosphatase (ALP) are within the normal laboratory ranges.\n12. An individual has any of the following haematologic parameters, confirmed by repeat tests, during Screening:\n\n    * Lymphocyte count: \\\u003C1000\u002FμL\n    * Neutrophil count: \\\u003C1500\u002FμL\n    * Platelet count: \\\u003C100 000 platelets\u002FμL\n    * Haemoglobin: \\\u003C10 g\u002FdL Note: Specific haematologic, oncologic or other systemic conditions that might otherwise result in exclusion and\u002For is heretofore unrecognised should be considered in individuals who have one or more blood cell counts below or above the normal ranges.\n13. Current or prior (within 5× half-lives before SV2 for Parts A and B, or within 5x half-lives of Day 1 TP3 for Part C) treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including systemic glucocorticoids, verapamil, baricitinib, and others. Note: Inhaled and topical corticosteroids are allowed. Short courses, i.e., approximately 2 weeks or less, of systemic corticosteroids for transient conditions are allowed.\n14. Current or prior (within 5× half-lives before SV2 for Parts A and B, or within 5x half-lives of Day 1 TP3 for Part C) use of drugs other than insulin to treat hyperglycaemia (e.g., metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, glucagon-like peptide 1 agonists \\[glucagon-like peptide-1\\], dipeptidyl peptidase-4 \\[DPP-IV\\] inhibitors, or amylin).\n15. Current or prior (within 5× half-lives before SV2 for Parts A and B, or within 5x half-lives of Day 1 TP3 for Part C) use of any medication known to significantly influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, niacin).\n16. Current or planned highly restrictive dietary regimen(s) that would interfere with participant well-being or impact to investigational drug.\n17. Recent or planned vaccinations as follows:\n\n    Countries within EU member states only:\n    * Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): From 30 days before dosing through 6 months following administration or SAB-142 for each TP.\n    * Recombinant, inactivated or otherwise \"non-live\" vaccines: From 30 days before dosing or within 60 days following dosing; or planned\u002Frequired within 30 days prior to or 60 days following Day 1 of TP2.\n\n    All other countries:\n    * Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): Within the 30 days before dosing or within 30 days following dosing; or planned\u002Frequired within 30 days following Day 1 of each TP.\n    * Recombinant, inactivated or otherwise \"non-live\" vaccines: Within the 30 days before dosing before dosing or within 30 days following dosing; or planned\u002Frequired within 30 days prior to or 30 days following Day 1 of TP.\n18. Female is lactating and\u002For plans to lactate with the intent to provide her own breast milk to a baby at any point during the study.\n19. An individual who has a history of alcohol, drug, or chemical abuse within 12 months prior to study screening (positive tetrahydrocannabinol is allowed) Note: Abuse is defined according to local, regional and\u002For country specific guidance. Participants who are tested positive for illicit substances but have a prescription medication to manage their concomitant conditions such as attention-deficit\u002Fhyperactivity disorder (ADHD) or others are allowed to participate in the study.\n20. An individual who has a medical, psychological or social condition that, in the opinion of the Investigator, would interfere with safe and proper completion of the trial.\n21. An individual who is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site.\n22. An individual who is considered failing to thrive or extremely obese may be excluded based on assessment by the PI, or if participation in the study may place the participant at risk.\n23. An individual who has been placed in an institute by official or court order.","5 Years","40 Years",{"count":188,"type":22},159,[83],"This is a Phase 2b, investigator- and participant-blinded, placebo-controlled, parallel-arm study to evaluate the efficacy, safety and tolerability of SAB 142 in patients with Stage 3 New Onset of Type 1 Diabetes (NOT1D).",[192],"Type 1 Diabetes",{"date":63,"type":33},{"date":195,"type":33},"2025-11-25",{"date":197,"type":22},"2028-12",{"name":199,"class":40},"SAb Biotherapeutics, Inc.",70,{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"100566436","phase-2-a-study-to-assess-the-efficacy-and-safety-of-efgartigimod-ph20-sc-in-adults-with-systemic-sclerosis-100566436","NCT06655155","A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis","A Randomized, Double-Blinded, Placebo-Controlled, Phase 2, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Adult Participants With Systemic Sclerosis","eSScape","Inclusion Criteria:\n\n* Is aged ≥18 years and the local legal age of consent for clinical studies\n* Has diffuse or limited SSc diagnosis and fulfills the 2013 ACR\u002FEULAR classification criteria\n* Has a positive antinuclear antibodies (ANA) test result at the central laboratory with titer of at least 1:160\n* Has a Health Assessment Questionnaire-Disability Index (HAQ-DI) score of at least 0.5 OR a Patient Global Assessment (PGA) score of at least 3\n* Has a modified Rodnan Skin Score (mRSS) score between 15 and 35\n* The participant is anti-RNA polymerase III autoantibody negative at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 5 years before screening or the participant is anti-RNA polymerase III autoantibody positive at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 2 years before screening\n* Has uninvolved or mildly thickened skin area in at least 1 injection site\n\nExclusion Criteria:\n\n* Isolated anticentromere antibodies (ACA) seropositivity at the central laboratory\n* Significant Pulmonary Arterial Hypertension\n* Severe digital vasculopathy within the past 3 months\n* Skin thickening due to scleroderma mimics or localized scleroderma\n* Scleroderma renal crisis within the past 6 months of participating to the study\n* Another rheumatic autoimmune disease, except for secondary Sjögren's syndrome or fibromyalgia",{"count":210,"type":22},81,[83],"The main purpose of this study is to evaluate the effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis. The study consists of a screening period, a treatment period of up to 48 weeks and a safety follow-up period. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod PH20 SC or placebo. The total study duration can be up to approximately 15 months.\n\nMore information can be found on: https:\u002F\u002Fclinicaltrials.argenx.com\u002Fesscape",[214],"Systemic Sclerosis (SSc)",{"date":30,"type":33},{"date":217,"type":33},"2024-11-11",{"date":219,"type":22},"2027-09",{"name":221,"class":40},"argenx",77,{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":232,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":249},"100554453","phase-3-a-study-of-elritercept-to-treat-anemia-in-adults-with-very-low-low-or-intermediate-risk-myelodysplastic-syndromes-mds-who-need-regular-blood-transfusions-100554453","NCT06499285","A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants With Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)","Inclusion Criteria:\n\n* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information and\u002For protected personal data in accordance with national and local study participant data protections and privacy regulations.\n* Male or female greater than or equal to (≥)18 years of age at the time of signing informed consent.\n* Diagnosis of MDS with or without RS (as determined in an evaluable bone marrow aspirate, read by an independent central reader to confirm diagnosis at Screening) according to the World Health Organization 2016 classification that meets the International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease.\n* Transfusion dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either:\n\n  a. Low-transfusion burden (LTB), defined as 4 to 7 red blood cells (RBC) units per 16 weeks; or b. High-transfusion burden (HTB), defined as ≥8 RBC units per 16 weeks; and c. For all participants: i. Only transfusion events for a pretransfusion hemoglobin (Hgb) lesser than (\\\u003C)10 grams per deciliter (g\u002FdL) are counted toward eligibility; ii. At least 1 transfusion event in each 8-week period and a minimum of 2 transfusion events separated by ≥7 days within the 16-week period immediately preceding randomization; and iii. No consecutive 56-day period can be RBC transfusion-free during the 16-week period immediately preceding randomization.\n* Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued ≥4 weeks before randomization), or unlikely to respond to ESA treatment, defined as follows:\n\n  a. Refractory to prior ESA treatment: documentation of nonresponse or a response that was no longer maintained with a prior ESA-containing regimen, either as a single agent or combination (e.g., with granulocyte colony-stimulating factor \\[G-CSF\\]); ESA regimen must have been either: i. Recombinant human erythropoietin (EPO) ≥40,000 international units per week (IU\u002Fweek) for ≥8 doses or equivalent; or ii. Darbepoetin alpha ≥500 micrograms (μg) every 3 weeks for ≥4 doses or equivalent.\n\n  b. Intolerant to prior ESA treatment: documentation of discontinuation of a prior ESA-containing regimen, either as a single agent or combination (e.g., with G-CSF), at any time after introduction due to intolerance or an AE.\n\n  c. Unlikely to respond to ESA treatment: low chance of response to ESA based on an endogenous serum EPO level greater than (\\>)200 units per liter (U\u002FL).\n* Less than 5% blasts in an evaluable bone marrow aspirate collected at Screening, read by an independent central reader.\n* Eastern Cooperative Oncology Group performance status of 0 to 2.\n* Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception.\n* In the opinion of the Investigator, the participant is able and willing to comply with the requirements of the protocol (e.g., all study procedures, return for follow-up visits).\n\nExclusion Criteria:\n\n* Del(5q) MDS or therapy-related (secondary) MDS.\n* Anemia due to any other known cause (e.g., thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and\u002For folate).\n* Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks before randomization.\n* Clinically significant cardiovascular disease defined as:\n\n  1. New York Heart Association heart disease class III or IV;\n  2. Fridericia corrected QT (QTcF) interval \\>500 milliseconds during Screening;\n  3. Presence of uncontrolled hypertension defined as mean systolic blood pressure ≥160 millimeters of mercury (mm Hg) or diastolic blood pressure ≥100 mm Hg during Screening; or\n  4. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before Screening.\n* Known ejection fraction \\\u003C35%, confirmed by a local echocardiogram performed during Screening, or a previously performed echocardiogram if collected within 6 months before Screening.\n* Child-Pugh class C hepatic impairment.\n* Stroke, deep vein thrombosis, or pulmonary embolism within 6 months before Screening.\n* Any known history of acute myeloid leukemia (AML).\n* Prior history of malignancies, other than MDS, unless participant has been free of the disease (including completion of any treatment, including maintenance, for prior malignancy) for ≥ 5 years. However, participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:\n\n  1. Basal or squamous cell carcinoma of the skin;\n  2. Carcinoma in situ of the cervix;\n  3. Carcinoma in situ of the breast; and\u002For\n  4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis \\[TNM\\] clinical staging system).\n* History of solid organ or bone marrow transplantation.\n* Active infection requiring intravenous treatment (e.g., antibiotics, antifungals, or antivirals) within 28 days, or oral treatment within 14 days before randomization.\n* History of or known active chronic infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV). Participants without known positive history of HIV, HBV, and\u002For HCV do not require further testing, unless testing is mandated per local guidelines.\n* Body mass index ≥ 40 kilograms per meter square (kg\u002Fm\\^2).\n* Major surgery within 28 days before randomization.\n* History of allergy\u002Fanaphylaxis to investigational medicinal product (IMP) excipients (refer to the current elritercept IB for a list of excipients) or recombinant proteins.\n* Prior use of elritercept, luspatercept, or sotatercept.\n* Prior use of hypomethylating agents (HMAs), isocitrate dehydrogenase inhibitor, lenalidomide, imetelstat, or immunosuppressive therapy given for treatment of MDS.\n* Iron chelation therapy initiated within 8 weeks before randomization. Participants on stable doses of iron chelation therapy for ≥ 8 weeks are allowed.\n* Vitamin B12 or folate therapy initiated within 4 weeks before randomization. Participants on stable replacement doses for ≥ 4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.\n* Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥ 8 weeks are allowed.\n* High-dose corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone lesser than or equal to (≤) 10 mg\u002Fday or corticosteroid equivalent for ≥ 4 weeks are allowed.10 mg\u002Fday or corticosteroid equivalent for ≥ 4 weeks are allowed.\n* Treatment with any investigational drug within 28 days before Screening or, if the half-life of the product is known, within 5 times the half-life before Screening, whichever is longer.\n* Ongoing participation in another interventional clinical study.\n* Serum EPO level \\>500 U\u002FL.\n* Platelet count ≥450 × 10\\^9\u002FL or ≤25 × 10\\^9\u002FL.\n* Absolute neutrophil count ≤ 500\u002FµL.\n* Serum aspartate aminotransferase or alanine aminotransferase ≥3 × the upper limit of normal (ULN).\n* Total bilirubin ≥2 × ULN unless attributable to Gilbert's syndrome.\n* Ferritin ≤ 50 micrograms per litre (μg\u002FL).\n* Folate ≤2.0 nanograms per milliliter (ng\u002FmL).\n* Vitamin B12 ≤200 picograms per milliliter (pg\u002FmL).\n* Estimated glomerular filtration rate \\\u003C30 milliliters per minute per 1.73 meter square (mL\u002Fmin\u002F1.73m\\^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Collaboration equation.\n* Pregnant or lactating female.\n* Any other condition not specifically noted above that, in the opinion of the Investigator, would preclude the participant from participating in the study or could confound interpretation of data from the study.\n* Investigational site staff members directly involved in the conduct of the study and site staff members otherwise supervised by the Investigator, employees of the Sponsor or contract research organization (CRO) directly involved in the conduct of the study, or immediate family members (defined as a spouse, parent, child, or sibling, whether biological or legally adopted).\n* For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults (per applicable French law \\[Art. L. 1121-6, Art. L. 1121-8, Art. L. 1121-8-1\\]).",{"count":231,"type":22},225,[25],"The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs. The study will also check on how safe elritercept is and how well it is tolerated.",[235],"Myelodysplastic Syndromes",[237,238,239,240,241],"Anemia","Elritercept","Myelodysplastic neoplasms","KER-050","MDS",{"date":30,"type":33},{"date":244,"type":33},"2025-05-06",{"date":246,"type":22},"2032-05-01",{"name":248,"class":40},"Takeda",177,{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":17,"minAge":257,"maxAge":160,"enrollmentInfo":258,"targetDuration":4,"studyType":23,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":264,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":270},"100549191","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-tulisokibart-mk-7240-in-participants-with-moderate-to-severe-crohns-disease-mk-7240-008-100549191","NCT06430801","A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.\n* Has moderately to severely active CD.\n* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and\u002For small molecule advanced therapies.\n* Adolescent participants ≥16 and \\\u003C18 years of age can participate if approved by the country or regulatory\u002Fhealth authority.\n\nExclusion Criteria:\n\n* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.\n* Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and\u002For ileal involvement.\n* Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.\n* Has current stoma or need for colostomy or ileostomy.\n* Is missing \\>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.\n* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.\n* Has surgical bowel resection within 3 months of study.\n* Has prior or current gastrointestinal dysplasia.\n* Has chronic infection requiring ongoing antimicrobial treatment.\n* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years.\n* Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n* Has active tuberculosis.\n* Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.\n* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).","16 Years",{"count":259,"type":22},1200,[25],"The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 52 (US\u002FFDA and EU\u002FEMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA).",[263],"Crohn's Disease",{"date":30,"type":33},{"date":266,"type":33},"2024-06-05",{"date":268,"type":22},"2029-11-12",{"name":150,"class":40},499,{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":23,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":291},"100526585","phase-3-a-study-of-opevesostat-mk-5684-versus-alternative-next-generation-hormonal-agent-nha-in-metastatic-castration-resistant-prostate-cancer-mcrpc-post-one-nha-mk-5684-004-100526585","NCT06136650","A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)","MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology\n* Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening\n* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and\u002For soft tissue disease shown by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n* Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) (metastatic hormone-sensitive prostate cancer \\[mHSPC\\] or non-metastatic hormone-sensitive prostate cancer \\[nmHSPC\\]), or castration-resistant prostate cancer (CRPC) (metastatic castration-resistant prostate cancer \\[mCRPC\\] or non-metastatic castration-resistant prostate cancer \\[nmCRPC\\]), for at least 8 weeks of NHA treatment (at least 14 weeks of NHA treatment for participants with bone progression). Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than 6 cycles of docetaxel and had no radiographic disease progression while receiving docetaxel\n* Has had prior treatment with poly (ADP-ribose) polymerase inhibitor (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment\n* Has ongoing androgen deprivation therapy (ADT) with serum testosterone \\\u003C50 ng\u002FdL (\\\u003C1.7 nM)\n* Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 10 days before randomization\n* Has adequate organ function\n* Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Participants who have adverse event (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy or ≤Grade 2 osteopenia\u002Fosteoporosis are eligible\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has presence of gastrointestinal condition\n* Is unable to swallow capsules\u002Ftablets\n* Has history of pituitary dysfunction\n* Has poorly controlled diabetes mellitus\n* Has clinically significant abnormal serum potassium or sodium level\n* Has any of the following at screening visit: Hypotension: systolic blood pressure (BP) \\\u003C110 mmHg, or uncontrolled hypertension: systolic BP ≥160mmHg or diastolic blood BP ≥90 mmHg, in 2 out of the 3 recordings with optimized antihypertensive therapy\n* Has a history of active or unstable cardio\u002Fcerebrovascular disease, including thromboembolic events\n* History or family history of long QTc syndrome\n* Has a history of seizure(s) within 6 months before providing documented informed consent (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollment\n* Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place\n* Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC)\n* Has not adequately recovered from major surgery or have ongoing surgical complications\n* Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures\n* Participants on an unstable dose of thyroid hormone therapy, as judged by the investigator, within 6 months before the start of the study intervention\n* Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids\n* Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention\n* Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention\n* Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat\n* Has a \"superscan\" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention\n* Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed\n* Active infection requiring systemic therapy\n* Has concurrent active Hepatitis B virus and Hepatitis C virus infection",{"count":279,"type":22},1314,[25],"The purpose of this study is to assess the efficacy and safety of opevesostat plus daily corticosteroids compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as assessed by Blinded Independent Central Review (BICR), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.",[283,284],"Metastatic Castration-resistant Prostate Cancer (mCRPC)","Prostatic Neoplasms",{"date":63,"type":33},{"date":287,"type":33},"2023-12-18",{"date":289,"type":22},"2030-12-02",{"name":150,"class":40},330,{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":23,"phases":302,"briefSummary":303,"conditions":304,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":312},"100522066","phase-3-a-study-of-intismeran-autogene-v940-plus-pembrolizumab-mk-3475-versus-placebo-plus-pembrolizumab-in-participants-with-non-small-cell-lung-cancer-v940-002-100522066","NCT06077760","A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)","A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)","INTerpath-002","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.\n* Has no evidence of disease before randomization.\n* Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.\n* No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma.\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Received prior neoadjuvant therapy for their current NSCLC diagnosis.\n* Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.\n* Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Active infection requiring systemic therapy.",{"count":301,"type":22},868,[25],"The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \\[N2\\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.",[305],"Non-small Cell Lung Cancer",{"date":30,"type":33},{"date":308,"type":33},"2023-12-06",{"date":310,"type":22},"2035-12-21",{"name":150,"class":40},229,{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":320,"targetDuration":4,"studyType":23,"phases":322,"briefSummary":318,"conditions":323,"keywords":325,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":335},"100410708","phase-3-phase-iii-study-of-induction-and-consolidation-chemotherapy-with-venetoclax-in-patients-with-newly-diagnosed-aml-or-mds-eb-2-100410708","NCT04628026","Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2","A Randomized, Placebo-Controlled Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2","Inclusion Criteria:\n\n1. Patients with newly diagnosed acute myeloid leukemia (AML) according to the International Consensus Classification (ICC).\n2. Age ≥ 18 and ≤ 75 years.\n3. Patients considered eligible for intensive chemotherapy.\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n5. Molecular analysis centrally performed in AMLSG and HOVON laboratories.\n6. Adequate renal function as evidenced by serum creatinine ≤ 2.0 × upper limit of norm (ULN) or creatinine clearance \\>40 mL\u002Fmin based on the Cockcroft-Gault glomerular filtration rate (GFR).\n7. Adequate hepatic function as evidenced by:\n\n   * Serum total bilirubin ≤ 2.5 × ULN unless considered due to Gilbert's disease, or leukemic involvement following approval by the Principal Investigators or Trial Coordinators of the study\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to leukemic involvement following approval by the Principal Investigators or Trial Coordinators.\n8. No prior chemotherapy for AML, except hydroxyurea for up to 14 days during the diagnostic screening phase for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell \\[WBC\\] counts \\> 25x109\u002FL); patients may have had previous treatment with erythroid stimulating agents (ESA) or hypomethylating agents (HMAs) for an antecedent phase of MDS; ESA and HMAs have to be stopped at least four weeks before start of study treatment.\n9. Patients must not have received a known strong or moderate CYP3A inducer 7 days before start of study treatment. Patients must have no known medical conditions requiring chronic therapy with moderate or strong CYP3A inducers.\n10. Female patient must either:\n\n    * Be of nonchildbearing potential:\n\n      * Postmenopausal (defined as at least 1 year without any menses)\n      * Documented surgically sterile (e.g. documented hysterectomy, bilateral oophorectomy, bilateral salpingectomy or congenital sterile) or status post hysterectomy (at least 1 month prior to screening)\n    * Or, if of childbearing potential (not surgically sterile and not postmenopausal)\n\n      * Not planning to become pregnant during the study and for 6 months after the final study drug administration\n      * And have a negative urine or serum pregnancy test at screening\n      * And, if heterosexually active, agree to consistently apply one highly effective\\* method of birth control in combination to a barrier method for the duration of the study and for 27 weeks after the final study drug administration\n\n        \\*Highly effective forms of birth control include\n      * Consistent and correct usage of established hormonal contraceptives that inhibit ovulation for at least 1 month prior to taking study drug. (hormonal contraception is only a highly effective method of birth control, if a combined \\[estrogen and progestogen containing\\] hormonal contraception or a progestogen-only hormonal contraception - both associated with inhibition of ovulation - is used.\n      * Established intrauterine device (IUD) or intrauterine system (IUS)\n      * Bilateral tubal occlusion\n      * Vasectomy - a vasectomy is highly effective contraception method provided the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used.\n      * Male is sterile due to a bilateral orchiectomy.\n      * Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual activity during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient.\n\n        \\*List is not all inclusive. Prior to enrolment, the investigator is responsible for confirming patient will utilize highly effective forms of birth control in combination with a barrier method according to locally accepted standards during the protocol defined period.\n      * Female patient must agree not to breastfeed starting at screening and throughout the study period, and for 2 months and 1 week after the final study drug administration.\n      * Female patient must not donate ova starting at screening and throughout the study period, and for 27 weeks after the final study drug administration.\n11. Men must use a latex condom during any sexual contact with WOCBP, even if they have undergone a successful vasectomy and must agree to avoid to father a child (while on therapy and for 27 weeks after the final study drug administration). In addition, their female partners of childbearing potential have to use a highly effective method of birth control.\n12. Male patient must not donate sperm starting at screening and throughout the study period and for 27 weeks after the final study drug administration.\n13. Able to understand and willing to sign an informed consent form (ICF).",{"count":321,"type":22},650,[25],[324],"Acute Myeloid Leukemia",[326],"adult patients",{"date":63,"type":33},{"date":329,"type":33},"2022-09-13",{"date":331,"type":22},"2032-02",{"name":333,"class":334},"University of Ulm","OTHER",91,{"id":337,"slug":338,"hasResults":12,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":12,"sex":17,"minAge":343,"maxAge":344,"enrollmentInfo":345,"targetDuration":4,"studyType":23,"phases":347,"briefSummary":348,"conditions":349,"keywords":351,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":362},"100360147","phase-3-a-phase-3-study-of-etelcalcetide-in-children-with-secondary-hyperparathyroidism-receiving-hemodialysis-100360147","NCT03969329","A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis","Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to \u003C 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis","Inclusion Criteria:\n\n* Participant's legally acceptable representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and\u002For guidelines prior to any trial-specific activities\u002Fprocedures being initiated.\n* Male or female participants greater than or equal to 2 to less than 18 years of age at the time of enrollment.\n* Targeted dry weight greater than or equal to 7 kg at the time of screening Week -1.\n* Diagnosed with CKD and SHPT undergoing hemodialysis\u002Fhemodiafiltration TIW or four times a week (QIW) at the time of screening greater than or equal to 1 month.\n* Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values greater than 300 pg\u002FmL during screening, on separate days and within 2 weeks of enrollment obtained from the central laboratory during screening.\n* Serum corrected Ca value greater than or equal to 9.0 mg\u002FdL obtained from the central laboratory during screening.\n* Dialysate Ca level greater than or equal to 2.5 mEq\u002FL for at least 1 month prior to screening and throughout the duration of the trial.\n* participant receiving active vitamin D sterols must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through enrollment, and be expected to maintain stable doses for the duration of the trial, except for adjustments allowed per protocol.\n* participant receiving phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through enrollment, and be expected to maintain stable dose for the duration of the trial, except for adjustments allowed per protocol.\n* Subject receiving Ca supplements must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through enrollment, and be expected to maintain stable dose for the duration of the trial, except for adjustments allowed per protocol.\n* SHPT not due to vitamin D deficiency, per investigator assessment.\n\nExclusion Criteria:\n\n* Disease Related:\n* History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmia's, history of symptomatic ventricular dysrhythmias Torsades de Pointes or other conditions associated with prolonged QT interval.\n* Anticipated or scheduled parathyroidectomy during the trial period.\n* Anticipated or scheduled kidney transplant during the trial period.\n* Participant has received a parathyroidectomy within 6 months prior to enrollment.\n* Other Medical Conditions:\n* Current malignancy or history of other malignancy, except non-melanoma skin cancers within the last 5 years.\n* Prior\u002FConcomitant Therapy:\n* Use of concomitant medications that may prolong the QTc (eg, ondansetron, albuterol, sotalol, amiodarone, erythromycin, or clarithromycin). Refer to CredibleMeds.org for guidance. Certain medications may be allowed based on review by the Medical Monitor and require additional electrocardiogram (ECG) monitoring and potential electrolyte monitoring.\n* Receipt of cinacalcet therapy within 30 days prior to screening and through enrollment.\n* Any previous use of etelcalcetide prior to screening and through enrollment (Original protocol, Amendment 1, and Amendment 2 only).\n* Receipt of etelcalcetide therapy within 6 months prior to screening assessments and through enrollment (Amendment 3 and later only).\n* All herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to enrollment, and continuing use if applicable, will be reviewed by the Principal Investigator and the Amgen Medical Monitor. Written documentation of the review and Amgen acknowledgment is required for participant participation.\n* Use of any over-the-counter or prescription medications within the 14 days or 5 half-lives (whichever is longer) prior to enrollment that are not established therapies for participants with renal disease or other conditions secondary to renal disease will be reviewed by the Principal Investigator and the Amgen Medical Monitor. Written documentation of the review and Amgen acknowledgment is required for participant participation. Paracetamol for analgesia will be allowed.\n* Prior\u002FConcurrent Clinical Trial Experience:\n* Currently receiving treatment in another investigational device or drug trial, or less than 30 days since ending treatment on another investigational device or drug trial(s). Other investigational procedures while participating in this trial are excluded.\n* Diagnostic Assessments During Screening:\n* Participant has significant abnormalities on the most recent central laboratory test during the screening period prior to enrollment per the Investigator including but not limited to the following: a. Serum transaminase (alanine aminotransferase \\[ALT\\] or serum glutamic pyruvic transaminase \\[SGPT\\], aspartate aminotransferase \\[AST\\], or serum glutamic oxaloacetic transaminase \\[SGOT\\]) greater than 1.5 times the upper limit of normal (ULN).\n* Corrected QT interval greater than 500 ms, using Bazett's formula.\n* Corrected QT interval greater than or equal to 450 to less than or equal to 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist.\n* Participant has a clinically significant ECG abnormality (eg, unstable arrhythmia) during screening that, in the opinion of the investigator, could pose a risk to participant safety or interfere with the trial evaluation.\n* Within the 3 Months Prior to Screening:\n* New onset or worsening of a pre-existing seizure disorder.\n* Participants on anti-convulsant medication must be on a stable and therapeutic dose for 3 months prior to screening (if blood level monitoring is clinically available, then the participant must have a therapeutic blood level within 1 week of enrollment).\n\nOther Exclusions:\n\n* Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 3 months after the last dose of etelcalcetide. (Females of childbearing potential should only be included in the trial after a confirmed menstrual period and a negative highly sensitive serum pregnancy test within 7 days prior to the first dose of investigational product).\n* Female participants of childbearing potential unwilling to use 1 highly effective or acceptable method of effective contraception during treatment and for an additional 3 months after the last dose of investigational product.\n* Female participants of childbearing potential with a positive pregnancy test assessed at screening by a serum pregnancy test.\n* Participant has known sensitivity to etelcalcetide or excipients to be administered during dosing.\n* Participant likely to not be available to complete all protocol-required trial visits or procedures, and\u002For to comply with all required trial procedures to the best of the participant and investigator's knowledge.\n* History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) or unacceptable physical findings, that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the trial evaluation procedures or completion.\n* Participant has previously entered this trial or previously received treatment with etelcalcetide (Original protocol, Amendment 1 and Amendment 2 only).\n* Participant previously has entered this trial (Amendment 3 and later only).\n* Anemia, which in the opinion of the investigator makes it not advisable to undergo sequential blood draws.\n* History of unstable chronic heart failure within the last 1 year prior to screening.","2 Years","17 Years",{"count":346,"type":22},24,[25],"Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric participants between ≥ 2 to \\\u003C 18 years of age, with chronic kidney disease (CKD) on hemodialysis.",[350],"Secondary Hyperparathyroidism",[352,353,354],"Secondary hyperparathyroidism (sHPT)","Chronic kidney disease (CKD)","Paediatric",{"date":30,"type":33},{"date":357,"type":33},"2019-12-20",{"date":359,"type":22},"2027-06-30",{"name":361,"class":40},"Amgen",23,{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":23,"phases":373,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":385},"100631162","phase-3-a-study-to-test-whether-nerandomilast-helps-people-with-systemic-sclerosis-100631162","NCT07497087","A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis","A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Oral Nerandomilast Treatment in Patients With Systemic Sclerosis (SSc)","VERANDA™-SSc","Inclusion criteria:\n\n1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.\n2. Patients must be at least 18 years of age and fulfil the 2013 American College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology (ACR\u002FEULAR) criteria for SSc.\n3. Patients must be diagnosed with limited cutaneous SSc (lcSSc) or diffuse cutaneous SSc (dcSSc), as defined by LeRoy et al. (1988).\n4. Disease onset (defined by first non-RP \\[Raynaud's phenomenon\\] symptom) must be within 7 years of Visit 1.\n5. Trial participants with dcSSc must have evidence of active disease during screening.\n6. Trial participants with lcSSc must have evidence of active disease during screening. LcSSc patients must be anti-centromere antibody (ACA) negative.\n7. FVC % predicted ≥45% at Visit 1.\n8. Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % predicted ≥25% corrected for haemoglobin (Hb) at Visit 1.\n9. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control.\n10. Patients may be either untreated or on stable treatment with permitted immunosuppressive\u002Fimmunomodulatory agents and\u002For nintedanib. All treatments must remain stable prior to Visit 2 and during the screening period\n\nExclusion criteria:\n\n1. Active, unstable, or uncontrolled vasculitis within 8 weeks prior to Visit 1 or during the screening period.\n2. Any suicidal behaviour in the past 2 years.\n3. Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months. Further exclusion criteria apply.",{"count":372,"type":22},448,[25],"Nerandomilast is being developed to help people with systemic sclerosis by potentially improving symptoms and slowing disease progression. This study is open to adults who are at least 18 years old and have systemic sclerosis (SSc). People can join the study if they have limited or diffuse cutaneous SSc with disease onset within 7 years of the first non-Raynaud's symptom. The purpose of this study is to find out whether a medicine called nerandomilast helps people with systemic sclerosis. This study also aims to find out how well nerandomilast is tolerated in people with systemic sclerosis.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take the tablets twice a day.\n\nParticipants are in the study for 1 to about 4 years. During this time, they visit the study site regularly and get phone calls from the site staff. During study visits participants regularly have blood samples taken and doctors check changes in skin thickening, lung function, and internal organs, overall health and the safety and tolerability of study treatment in people with SSc. The results are compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[376],"Systemic Sclerosis","2026-08-19",{"date":169,"type":33},{"date":380,"type":33},"2026-07-27",{"date":382,"type":22},"2030-03-17",{"name":384,"class":40},"Boehringer Ingelheim",246,{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":17,"minAge":257,"maxAge":160,"enrollmentInfo":394,"targetDuration":4,"studyType":23,"phases":396,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":399,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":406},"100607164","phase-3-an-induction-study-to-investigate-the-efficacy-and-safety-of-duvakitug-in-participants-with-moderately-to-severely-active-ulcerative-colitis-100607164","NCT07184996","An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis","A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Induction Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis.","SUNSCAPE-1","Inclusion Criteria:\n\n* Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to \\\u003C18 years of age who meet the definition of Tanner Stage 5 for development\n* Confirmed diagnosis of moderately to severely active UC for at least 3 months prior to Baseline\n* Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies\n\nExclusion Criteria:\n\n* Participants with Crohn's Disease (CD), indeterminate colitis\n* Current diagnosis of Ulcerative Proctitis\n* Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of \\>3 bowel resections\n* Prior or current high-grade gastrointestinal (GI) dysplasia\n* Participants on treatment with but not on stable doses of conventional therapies prior to baseline\n* Participants with prohibited medications or therapies prior to baseline\n* Participants with previous exposure to anti-TL1A investigational therapy The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":395,"type":22},980,[25],"This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include:\n\nThe study duration may be up to 35 weeks with:\n\n* Screening period\n* 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction)\n* 12-week Sub-Study 3 (Extended Induction for non-responders)\n* 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359)\n\nThe treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.",[86],{"date":169,"type":33},{"date":401,"type":33},"2025-10-08",{"date":403,"type":22},"2028-05-09",{"name":405,"class":40},"Sanofi",219,{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":23,"phases":416,"briefSummary":417,"conditions":418,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":422,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":428},"100597898","phase-3-easi-protkt---a-study-to-test-vicadrostat-bi-690517-taken-together-with-empagliflozin-in-people-with-type-2-diabetes-high-blood-pressure-and-cardiovascular-disease-100597898","NCT07064473","EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease","EASi-PROTKT™ - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Type 2 Diabetes, Hypertension and Established Cardiovascular Disease","Inclusion Criteria :\n\n* At least 18 years old at time of consent\n* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n* Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).\n* Participants with medical history of hypertension and on active pharmacological treatment\n* Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment\n* Established cardiovascular (CV) disease and on active pharmacological treatment\n* At least one additional risk factor for developing heart failure (HF)\n\nExclusion Criteria:\n\n* History of HF or hospitalization for HF or treatment of HF\n* Atrial fibrillation or Atrial flutter with a resting heart rate \\>110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)\n* Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)\n* Treatment with an Mineralocorticoid receptor antagonist (MRA)\n* Treatment with amiloride or other potassium-sparing diuretic\n* Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial:\n\n  * A direct renin inhibitor (e.g. aliskiren)\n  * More than one Angiotensin-converting enzyme inhibitor (ACEi) and\u002For Angiotensin receptor blocker (ARB) (including Angiotensin receptor-neprilysin inhibitor (ARNi)) used simultaneously\n  * Other aldosterone synthase inhibitors (e.g. baxdrostat)\n  * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply.",{"count":415,"type":22},11800,[25],"This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine.\n\nParticipants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo.\n\nParticipants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.",[419,420,421],"Diabetes Mellitus, Type 2","Hypertension","Cardiovascular Diseases",{"date":169,"type":33},{"date":424,"type":33},"2025-07-22",{"date":426,"type":22},"2029-12-21",{"name":384,"class":40},1147,{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":17,"minAge":436,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":439,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":443,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":449},"100583174","phase-3-the-airtivity-study-a-study-to-find-out-whether-bi-1291583-helps-people-with-bronchiectasis-100583174","NCT06872892","The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis","A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of BI 1291583 2.5 mg Administered Once Daily for up to 76 Weeks in Patients With Bronchiectasis (The AIRTIVITY™ Study)","Inclusion criteria:\n\n* Male or female participants. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council of Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1 % per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the participant information.\n* Signed and dated written informed consent and assent, if applicable, prior to admission to the study, in accordance with GCP and local legislation.\n* Age of participants when signing the informed consent\u002Fassent ≥12 years.\n\n  \\-- Adolescents need to weigh at least 35 kg at Visit 1.\n* Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by CT scan where bronchiectasis has been documented by a radiologist.\n\nParticipants whose past CT scan image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than five years.\n\n* Adult participants should be able to produce sputum for Pseudomonas aeruginosa assessment during the screening period.\n* History of documented pulmonary exacerbations (assessed and recorded by the investigator) requiring antibiotic treatment. In the 12 months before Visit 1, participants must have had either:\n\n  * at least 2 exacerbations, or\n  * at least 1 exacerbation and an St. George's Respiratory Questionnaire (SGRQ) Symptoms score of \\>40 at screening Visit 1 (adults only)\n  * at least 1 exacerbation and high symptom burden according to the investigator's judgement (adolescents only) For participants on oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy (CFTR-MT), at least one exacerbation must have occurred since initiation of antibiotics or CFTR-MT.\n\nExclusion criteria:\n\n* Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation.\n* Allergic bronchopulmonary aspergillosis being treated or requiring treatment.\n* Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment\n* Any findings in the medical examination and\u002For laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the participant at risk by participating in the trial.\n* Any clinically relevant (at the discretion of the investigator) acute respiratory infection or ongoing pulmonary exacerbation at screening visit or during the screening unless recovered in the opinion of the investigator prior to Visit 2.\n* Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion of the investigator, may put the participant at risk by participating in the study.\n* Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to randomisation or scheduled during trial period.\n* Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated in situ non-melanoma skin cancers or in situ carcinoma of uterine cervix.\n* Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C hepatic impairment).\n* estimated Glomerular Filtration Rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (adults) or Chronic Kidney Disease Under 25 (CKiD-U25) (adolescents) \\\u003C30 mL\u002Fmin at Visit 1.\n* Previous treatment with a dipeptidyl peptidase-1 (DPP1) (Cathepsin C (CatC)) inhibitor. (Note: Participants that were randomised and only received placebo in studies with DPP1 (CatC) inhibitor are allowed.) Further exclusion criteria apply.","12 Years",{"count":438,"type":22},1755,[25],"This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations).\n\nThe purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months.\n\nParticipants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.",[442],"Bronchiectasis",{"date":169,"type":33},{"date":445,"type":33},"2025-06-09",{"date":447,"type":22},"2027-12-20",{"name":384,"class":40},471,{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":17,"minAge":458,"maxAge":18,"enrollmentInfo":459,"targetDuration":4,"studyType":23,"phases":461,"briefSummary":462,"conditions":463,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":466,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":473},"100474390","phase-3-a-study-to-learn-more-about-how-safe-the-study-treatment-finerenone-is-in-long-term-use-when-taken-with-an-ace-inhibitor-or-angiotensin-receptor-blocker-over-18-months-of-use-in-children-and-young-adults-from-1-to-18-years-of-age-with-chronic-kidney-disease-and-proteinuria-100474390","NCT05457283","A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria","An 18-month, Open-label, Single-arm Safety Extension Study of an age-and Bodyweight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria","FIONA OLE","Inclusion Criteria:\n\n* Participants must be ≥1 year to 18 years of age, at the time of signing the informed consent\u002Fassent.\n* Prior participation in the finerenone Phase 3 study FIONA (19920) and not permanently discontinued from treatment by the end of treatment (EoT) visit in FIONA.\n* Participants must have a clinical diagnosis of chronic kidney disease (CKD) at Visit 1 which is defined as\n\n  * CKD stages 1-3 (estimated glomerular filtration rate \\[eGFR\\] ≥30 mL\u002Fmin\u002F1.73m\\^2) for children ≥1 year to \\\u003C19 years of age at FIONA EoT and at Visit 1\n* Treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure (BP) management, unchanged for at least 30 days prior to Visit 1.\n* K+ ≤5.0 mmol\u002FL for children ≥2 years of age at both FIONA EoT and Visit 1, and ≤5.3 mmol\u002FL for children \\\u003C2 years of age at both FIONA EoT and Visit 1\n* Participants who have reached legal age of consent: Capable of giving signed informed consent.\n* Participant is able to receive enteral feeding (solid food, bottle or cup fed, feeding through nasogastric or gastric feeding tubes) with or without breastfeeding.\n\nExclusion Criteria:\n\n* Planned urological surgery expected to influence renal function\n* Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame\n* Systemic hypertension Stage 2 defined according to institutional guidelines on BP management at Visit 1.\n* Systemic hypotension defined as symptomatic hypotension or a mean systolic BP below the 5th percentile for age, sex and height but no lower than 80 mmHg for participants \\\u003C18 years and symptomatic hypotension or a mean systolic blood pressure (SBP) \\\u003C90 mmHg in participants ≥18 years at Visit 1.\n* Known hypersensitivity to the study treatment (active substance or excipients)\n* Severe hepatic insufficiency defined by e.g. Child-Pugh C or analogous scores.\n* Participants using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids\n* Concomitant therapy with a mineralocorticoid receptor antagonist (MRA)(eplerenone, spironolactone, esaxerenone, canrenone), any renin inhibitor (aliskiren, enalkiren, remikiren), any sodium-glucose co-transporter-2 (SGLT2) inhibitor (SGLT2i), sacubitril\u002Fvalsartan combination (ARNI), or potassium-sparing diuretic (amiloride, triamterene)\n* Concomitant therapy with both ACEI and ARBs together\n* Concomitant therapy with strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, moderate or strong CYP3A4 inducers\n* Previous assignment to treatment during this study\n* Simultaneous participation in another interventional clinical study (e.g., Phase 1 to 4 clinical studies).\n* Any suspected (serious) adverse event related to study intervention which led to permanent discontinuation during the FIONA study.\n* Pregnant or breastfeeding or intention to become pregnant during the study","1 Year",{"count":460,"type":22},100,[25],"Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine.\n\nThe kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and\u002For proteinuria. These include \"angiotensin-converting enzyme inhibitors\" (ACEI) and \"angiotensin receptor blockers\" (ARB). Both ACEI and ARB can help improve kidney function by reducing the activity of the renin-angiotensin-aldosterone system (RAAS). The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can impair the ability of the kidneys to work properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system.\n\nThe study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB.\n\nSo, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function.\n\nThe main purpose of this study is to learn how safe the treatment is when used of finerenone in addition to an ACEI or ARB in long-term.\n\nTo see how safe the treatment is, the study team will collect information on medical problems which are also known as \"treatment emergent adverse events\" (TEAEs). And they will also collect levels of an electrolyte called potassium in the blood by taking blood samples, and measure blood pressure during the study.\n\nThe secondary purpose of this study is to learn how well long-term use of finerenone can reduce the amount of protein in the participants' urine and benefit kidney function when taken with standard of care.\n\nTo see how the treatment works, the study team will collect participants' urine samples to assess urinary albumin-to-creatinine ratio (UACR) and urinary protein-to-creatinine ratio (UPCR), which are important assessments for calculating the level of protein in the urine. Researchers will also collect blood samples to analyze serum creatinine and calculate estimated glomerular filtration rate (eGFR). A significant decline in eGFR indicates worsening kidney function.\n\nThe study will include participants who had previously participated in FIONA study (NCT05196035). The participants will be aged from 1 year up to 18 years.\n\nThe participants will be in the study for approximately 19 months. They will take study treatment for up to 18 months and will be follow up for 1 month. During this period, at least 12 visits are planned for patients who newly start finerenone, and at least 8 visits for patients who already received finerenone.\n\nIn the visit, the study team will:\n\n* have their blood pressure, heart rate, temperature, height and weight measured\n* have blood and urine samples taken\n* have physical examinations\n* have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart)\n* answer questions about their medication and whether they have any adverse events, or have their parents or guardian's answer\n* answer questions about how they are feeling, or have their parents or guardian's answer\n* answer question about how they like the study medication, or have their parents or guardian's answer The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.\n\nThe doctors will check the participants' health about 30 days after the participants take their last treatment.",[56,464,465],"Proteinuria","Children",{"date":169,"type":33},{"date":468,"type":33},"2022-11-08",{"date":470,"type":22},"2028-11-07",{"name":472,"class":40},"Bayer",133,{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":23,"phases":484,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":505},"100601901","a-study-assessing-arrhythmia-mapping-with-a-multi-electrode-mapping-catheter-100601901","NCT07116525","A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter","Clinical Evaluation of Arrhythmia Mapping With a Paddle-shaped, High-density, Multi-electrode Mapping Catheter (an Exploratory Investigation)","FEATHER","Inclusion Criteria:\n\n* Diagnosed with and candidate for clinically indicated catheter mapping and ablation procedure for the management of ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation (participant having undergone a previous ablation procedure may be included)\n* At least one episode of the targeted arrhythmia (ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation) must have been documented by electrocardiogram (ECG), Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 12 months prior to enrollment\n* Age 18 years or older\n* Signed Patient Informed Consent Form (ICF)\n* Able and willing to comply with all pre-, post-, and follow-up testing and requirements\n\nExclusion Criteria:\n\n* Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non cardiac cause\n* Patients requiring left atrial procedures: left atrial size greater than (\\>) 55 millimeter (mm)\n* Left ventricular ejection fraction(LVEF) less than or equal to (\\\u003C=) 25 percentage (%) for participants with ventricular arrhythmia\n* LVEF \\\u003C= 40% for participants with atrial arrhythmia\n* Documented intracardiac thrombus as detected on imaging within 24 hours prior to insertion of the investigational catheter\n* Contraindication to anticoagulation (that is, heparin, warfarin, dabigatran)\n* History of blood clotting or bleeding abnormalities (example hypercoagulable state)\n* Myocardial infarction within the past 2 months (60 days)\n* Documented thromboembolic event (including transient ischemic attack \\[TIA\\]) within the past 12 months (365 days)\n* Uncontrolled heart failure or New York heart association (NYHA) function class IV\n* Implanted with a pacemaker or intracardiac cardiac defibrillator or appendage closure device within the past 6 weeks (42 days)\n* Patients with known untreatable allergy to contrast media\n* Active illness or active systemic infection or sepsis\n* Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation\n* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study\n* Participants that have ever undergone a percutaneous or surgical valvular cardiac procedure (that is, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)\n* Participants that currently have Impella or equivalent devices on the procedure date or up to 7 days prior\n* Any cardiac surgery within the past 60 days (2 months) (includes percutaneous coronary intervention \\[PCI\\])\n* Atrial septal closure within the past 6 weeks (42 days)\n* Presence of a condition that precludes vascular access\n* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation\n* Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being\n* Concurrent enrollment in an investigational study evaluating another device or drug",{"count":483,"type":22},90,[485],"NA","The purpose of this study is to assess the safety and feasibility of the investigational catheter for mapping the atrial and ventricular regions of the heart.",[488,489,490,491,492,493,494,495,496],"Scar-related Atrial Tachycardia","Persistent Atrial Fibrillation","Paroxysmal Atrial Fibrillation","Ventricular Tachycardia","Ischemic Ventricular Tachycardia","Non-ischemic Ventricular Tachycardia","Cardiomyopathy","Idiopathic Ventricular Tachycardia","Premature Ventricular Contraction","2026-08-18",{"date":377,"type":33},{"date":500,"type":33},"2025-09-15",{"date":502,"type":22},"2027-02-07",{"name":504,"class":40},"Biosense Webster, Inc.",6,{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":17,"minAge":257,"maxAge":160,"enrollmentInfo":514,"targetDuration":4,"studyType":23,"phases":516,"briefSummary":517,"conditions":518,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":526},"100607165","phase-3-a-maintenance-study-to-investigate-the-efficacy-and-safety-of-duvakitug-in-participants-with-moderately-to-severely-active-ulcerative-colitis-100607165","NCT07185009","A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis","A Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled, Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis","SUNSCAPE-2","Inclusion Criteria:\n\n* Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to \\\u003C18 years of age who meet the definition of Tanner stage 5 for development)\n* Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of SUNSCAPE-1\n* OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study\n\nExclusion Criteria:\n\n* Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator\n* Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":515,"type":22},751,[25],"This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC).\n\nStudy details include:\n\nThe study duration may be up to 286 weeks including:\n\n* 40-week Pivotal Maintenance Sub-Study\n* 240-week Open-Label Extension (OLE) Sub-Study\n* 45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.\n\nThe treatment duration may be up to 280 weeks including:\n\n* 40 weeks in Pivotal Maintenance Sub-Study\n* 240 weeks in OLE Sub-Study\n\nThe total number of on-site visit will be up to 32:\n\n* 21 visits in the Pivotal Maintenance Sub-Study.\n* 11 visits in the OLE Sub-Study.",[86],"2026-08-17",{"date":497,"type":33},{"date":522,"type":33},"2026-01-16",{"date":524,"type":22},"2033-04-28",{"name":405,"class":40},46,{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":533,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":535,"minAge":18,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":23,"phases":538,"briefSummary":539,"conditions":540,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":551},"100605713","phase-3-study-to-assess-the-efficacy-and-safety-of-rina-s-compared-to-treatment-of-investigators-choice-in-participants-with-endometrial-cancer-100605713","NCT07166094","Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer","A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy","RAINFOL-03","Key Inclusion Criteria\n\n* Participants must have histologically or cytologically confirmed recurrent or progressive endometrial cancer (EC; any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.\n* Participants must have received at least 1, but not more than 3, prior lines of therapy:\n\n  * Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination\n  * If the tumor recurred more than 12 months after completion of platinum-based chemotherapy, additional platinum-based chemotherapy must be administered for recurrent disease unless the participant is ineligible for further platinum-based chemotherapy, in which case the reason for ineligibility must be documented.\n\n    * Note: If Immunotherapy-based treatment is administered in the advanced\u002Frecurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from prior platinum-based chemotherapy. In such cases, the reason for ineligibility for platinum-based chemotherapy must be documented.\n  * Prior induction plus maintenance is considered 1 line of therapy\n  * Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.\n  * Therapy changed due to toxicity in the absence of progression will be considered part of the same line of therapy (i.e., will not be counted independently as a separate line of therapy)\n* Participants must have progressed radiographically on or after their most recent line of therapy\n\nKey Exclusion Criteria\n\n* Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.\n* Has a past or current malignancy other than the inclusion diagnosis before the planned first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated cervical carcinoma of Stage 1B or less, noninvasive basal cell or squamous cell skin carcinoma, noninvasive superficial bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥3 years (i.e., eligible participants must have complete response of ≥3 years duration).\n* Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after completion of brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the planned first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) of the brain prior to study entry.\n* Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility.\n\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.","FEMALE",{"count":537,"type":22},660,[25],"The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study.\n\nThe study duration will be approximately 3 years. The treatment duration will be different for every participant, but an average of 4 to 6 months is expected.\n\nAll participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s).",[541,542],"Endometrial Cancer","Recurrent or Progressive Endometrial Cancer","2026-08-14",{"date":519,"type":33},{"date":546,"type":33},"2025-11-28",{"date":548,"type":22},"2029-11",{"name":550,"class":40},"Genmab",160,{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":23,"phases":562,"briefSummary":563,"conditions":564,"keywords":566,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":583},"100570945","phase-3-impact-aml-a-randomized-pragmatic-clinical-trial-for-relapsed-or-refractory-acute-myeloid-leukemia-100570945","NCT06713837","IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.","IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia. IMPACT-AML RPCT","IMPACT-AML","Inclusion Criteria:\n\n* Non-Acute promyelocytic leukemia (APL) AML defined according World Health Organization (WHO) 2022 (or International Consensus Classification (ICC) 2022) criteria\n* 1st or 2nd relapse or refractory according to European leukemia Network (ELN) 2022\n* Patient is clinically candidate to both low intensity therapy and high dose chemotherapy in the opinion of the physician\n* Both low intensity therapy and high dose chemotherapy to which patient is candidate are available and can be provided as per local practice\n* No specific treatment protocol can be rationally considered better suited to patient needs.This specifically include, but is not limited to:\n\n  i) the availability of a drug that is already demonstrated superior to comparator arm and can be considered the only standard of care ii) specific contraindications related to fitness or any medical conditions that deem to avoid one of the two arms of this randomization iii) patient willingness to avoid one of the two arm of this randomization iv) lack of social support that make unfeasible one of the two arm of this randomization\n* Male or Female, aged\\>18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C4\n* A female participant is eligible to participate if she is not pregnant and not breastfeeding. If Women of childbearing potential (WOCBP), negative serum pregnancy test within 14 days of starting treatment must be obtained. WOCBP must adopt highly effective birth control methods, according to guideline \"Recommendation related to contraception and pregnancy testing in clinical trials\". Male patient and his female partner who is of childbearing potential must use 2 methods of birth control (a condom as a barrier method of contraception and one of the highly effective birth control methods, according to guideline \"Recommendation related to contraception and pregnancy testing in clinical trials\". Use of- and compliance to- birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug.\n* Participant is willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* Known contraindication to the study drug that will be selected by the treating physician within the list of high or low intensity treatment, according to most update version of Summary of Product Characteristics (SmPC) (e.g. hypersensitivity, allergy, organ failure precluding treatment)\n* Participation in another clinical trial with any investigational agents within 14 days or 5 drug half-lives (whatever comes first) prior to randomization\n* Active infections or other clinical conditions that in the opinion of the investigator make the patient ineligible to receive study treatment.",{"count":561,"type":22},339,[25],"This is a multicenter, randomized, open-label, pragmatic low intervention clinical trial comparing high intensity reinduction chemotherapy with low intensity therapies in 1st or 2nd relapse Acute Myeloid Leukemia. The study is funded by European Commission (HORIZON-MISS-2022-CANCER-01-03, Project ID 101104421)",[324,565],"Relapse\u002FRecurrence",[567,324,568,569,570,571,572,573,574],"Relapsed\u002FRefractory","Low Intensity therapy","Pragmatic","Low intervention Clinical trial","Randomized controlled trial","Horizon Europe","Mission Cancer","Diagnosis and treatment","2026-08-13",{"date":543,"type":33},{"date":578,"type":33},"2025-02-27",{"date":580,"type":22},"2028-01",{"name":582,"class":334},"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS",47,{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":590,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":17,"minAge":592,"maxAge":4,"enrollmentInfo":593,"targetDuration":4,"studyType":595,"phases":4,"briefSummary":596,"conditions":597,"keywords":600,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":610},"100551356","master-framework-for-relapse-or-refractory-acute-myeloid-leukemia-100551356","NCT06459024","Master Framework For Relapse or Refractory Acute Myeloid Leukemia","Master Framework For Relapse or Refractory Acute Myeloid Leukemia- IMPACT STREAM - A Prospective Observational Study of Treatment Outcomes","IMPACT STREAM","Inclusion Criteria:\n\n* Patients with AML diagnosis according to WHO2022 or ICC2022\n* Treatment failure (i.e. relapse, refractory or progression, including MRD) according to ELN2022 criteria\n* Participant or his\u002Fher legal representative is willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* Patients included in clinical trials may be enrolled except where otherwise specified in the experimental protocol.","6 Years",{"count":594,"type":22},4000,"OBSERVATIONAL","This is an observational (non-interventional), prospective, cohort study that will collects data from patients diagnosed with relapsed or refractory acute myeloid leukemia afferent to the participanting clinical sites",[598,599],"Acute Myeloid Leukemia, in Relapse","Acute Myeloid Leukemia Refractory",[601,602,324,603],"Relapsed","Refractory","Framework",{"date":543,"type":33},{"date":606,"type":33},"2024-06-28",{"date":608,"type":22},"2032-07",{"name":582,"class":334},40,{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":617,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":17,"minAge":436,"maxAge":344,"enrollmentInfo":619,"targetDuration":4,"studyType":23,"phases":620,"briefSummary":621,"conditions":622,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":637,"locationsCount":638},"100607922","phase-2-a-study-of-efgartigimod-iv-in-participants-from-12-years-to-less-than-18-years-of-age-with-chronic-immune-thrombocytopenia-itp-100607922","NCT07194850","A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)","A Multicenter, Randomized, Double-blinded, Parallel-Arm, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study Followed by an Open-Label Arm to Evaluate Efgartigimod IV in Pediatric Participants From 12 Years to Less Than 18 Years of Age With Chronic ITP","Advance Jr","Inclusion Criteria:\n\n* Is aged 12 to less than 18 years when completing the informed consent process\n* Has a documented duration of primary ITP of more than 12 months on the date the informed consent process is complete\n* Has documented prior ITP treatment with at least 1 of the following treatments: corticosteroids, IVIg, anti-D immunoglobulin, thrombopoietin receptor agonist (TPO-RAs), or rituximab.\n* Has documented prior response, defined as 1 platelet count of ≥50 × 10\\^9\u002FL to at least 1 of the following ITP treatments: prednisone, other or nonspecified corticosteroids, IVIg, or anti-D immunoglobulin\n* Has documented insufficient response to a prior ITP treatment with corticosteroids, IVIg, anti-D immunoglobulin, TPO-RAs, rituximab, or splenectomy\n* Has documented mean platelet count of less than 30 x10\\^9\u002FL\n\nExclusion Criteria:\n\n* Secondary ITP according to the following definition by the International Working Group (IWG): all forms of immune-mediated thrombocytopenia except primary ITP\n* Nonimmune thrombocytopenia\n* ITP-associated critical or severe bleeding\n* History of hereditary thrombocytopenia",{"count":346,"type":22},[83,25],"The main purpose of this study is to confirm the correct dose of efgartigimod IV for treating patients aged 12 to younger than 18 years with chronic immune thrombocytopenia (ITP).\n\nThe study consists of a double-blinded treatment period (DBTP) in which the participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV. At the end of the treatment period (up to 24 weeks), all participants will receive efgartigimod IV during the first year open-label treatment period (OLTP1). At the end of the first OLTP1, participants may begin a second year (OLTP2). After the OLTP2, the participants will enter a follow-up period (approximately 8 weeks) while off study drug. The participants will be in the study for up to 138 weeks.\n\nMore information can be found here: https:\u002F\u002Fclinicaltrials.argenx.com\u002Fadvancejunior",[623,624,625,626,627,628,629],"Immune Thrombocytopenia (ITP)","ITP - Immune Thrombocytopenia","ITP","Immune Thrombocytopenic Purpura","Immune Thrombocytopenic Purpura ( ITP )","Idiopathic Thrombocytopenic Purpura","Idiopathic Thrombocytopenic Purpura (ITP)","2026-08-11",{"date":632,"type":33},"2026-08-12",{"date":634,"type":33},"2025-10-20",{"date":636,"type":22},"2030-10",{"name":221,"class":40},21,""]