[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Estonia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":642},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,83,0,25,[9,42,71,89,116,143,170,194,219,247,277,298,319,343,366,387,409,431,450,479,516,536,565,591,619],{"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":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":86,"leadSponsor":87,"locationsCount":88},"100598128","phase-3-a-study-of-orelabrutinib-in-patients-with-primary-progressive-multiple-sclerosis-100598128","NCT07067463","A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis","A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis","Inclusion Criteria:\n\n* 18 to 60 years of age, inclusive\n* Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria\n* Participant must have documented evidence of disability progression observed during the 24 months before screening.\n* Expanded disability status scale (EDSS) score between 3.0 to 6.5 points, inclusive, at Screening.\n\nExclusion Criteria:\n\n* Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)\n* Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy.\n* History or current diagnosis of other neurological disorders that may mimic MS\n* History of any other significant active medical condition\n* History of suicidal behavior within 6 months prior to Screening\n* Any prior history of malignancy if no recurrence within 5 years\n* Patients on anticoagulation, or antiplatelet therapy will be excluded\n* Patients took strong\u002Fmoderate CYP3A inhibitors or strong\u002Fmoderate CYP3A inducerswithin 14 days\n* Clinically significant laboratory abnormalities at Screening.\n* Any allergy, contraindication, or inability to tolerate orelabrutinib or any of the excipients in the study intervention\n* Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening\n* History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.",{"count":79,"type":22},705,[25],"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 PPMS. Patients will be treated for approximately 30 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 705 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.",[83],"Multiple Sclerosis (MS) Primary Progressive",{"date":63,"type":33},{"date":35,"type":33},{"date":37,"type":22},{"name":39,"class":40},48,{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":23,"phases":99,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"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":98,"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.",[102],"Acromegaly",[104,105,106,107],"IGF-1","Growth hormone","Pituitary gland","Gigantism",{"date":63,"type":33},{"date":110,"type":33},"2025-11-26",{"date":112,"type":22},"2029-03",{"name":114,"class":40},"Debiopharm International SA",73,{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":23,"phases":125,"briefSummary":126,"conditions":127,"keywords":130,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":142},"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":124,"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.",[128,129],"Solid Tumors","Hematologic Malignancies",[131,132,133,134],"PD1","PD-1","PDL1","PD-L1",{"date":32,"type":33},{"date":137,"type":33},"2018-08-21",{"date":139,"type":22},"2043-08-04",{"name":141,"class":40},"Merck Sharp & Dohme LLC",782,{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":153,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100626791","phase-2-a-clinical-trial-of-eye201mk-8748-in-people-with-macular-degeneration-mk-8748-002-100626791","NCT07440225","A Clinical Trial of EYE201\u002FMK-8748 in People With Macular Degeneration (MK-8748-002)","A Randomized Double-masked, Multicenter, 3-arm, Pivotal Phase 2\u002F3 Study to Evaluate the Efficacy and Safety of Intravitreal (IVT) EYE201\u002FMK-8748 Compared to Aflibercept (2 mg) in Participants With Neovascular Age-related Macular Degeneration (NVAMD)","MALBEC","The main inclusion criteria include but are not limited to the following:\n\n* Has treatment naive choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) including subfoveal, juxtafoveal and extrafoveal lesions or retinal angiomatous proliferations (RAP) and polypoidal choroidal vascularization (PCV) lesions in at least one eye (study eye)\n* The diagnosis of neovascular age-related macular degeneration (NVAMD) must have been made within 21 days prior to starting study treatment\n\nThe main exclusion criteria include but are not limited to the following\n\n* Has uncontrolled blood pressure at screening\n* History of any prior macular laser photocoagulation in the study eye\n* History of uveitis in either eye\n* History of cataract surgery, minimally invasive glaucoma surgery, or Yttrium-Aluminium Garnet (Yag) laser capsulotomy in the study eye within 90 days before entering the study\n* Has uncontrolled glaucoma in the study eye\n* Active retinal disease other than the condition under investigation in the study eye\n* Has previously received anti- vascular endothelial growth factor (VEGF) therapy or other intravitreal (IVT) therapy in the study eye",{"count":152,"type":22},960,[154,25],"PHASE2","Researchers are looking for new ways to treat neovascular age-related macular degeneration (NVAMD).\n\nAvailable standard (usual) treatments for NVAMD, such as aflibercept, may not work for every person. Researchers want to learn if a trial medicine called tiespectus (also called MK-8748 or EYE201) can treat NVAMD.\n\nThe goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD.",[157,158,159,160],"Macular Degeneration","Age-Related Macular Degeneration","Choroidal Neovascularization","Wet Macular Degeneration","2026-08-20",{"date":63,"type":33},{"date":164,"type":33},"2026-03-27",{"date":166,"type":22},"2028-06-30",{"name":168,"class":40},"EyeBiotech Ltd.",110,{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":23,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":193},"100599987","phase-3-a-study-to-assess-the-efficacy-and-safety-of-empasiprubart-in-adults-with-cidp-100599987","NCT07091630","A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP","A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy","emnergize","Inclusion Criteria:\n\n* Meets criteria for CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021)\n* Has either typical CIDP or 1 of the following CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP\n* Has residual disability and active disease\n* Has not received previous treatment for CIDP; or has stopped receiving CIDP treatment; or is receiving CIDP treatment (pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors)\n* Participants already receiving CIDP treatment will have to discontinue their CIDP treatment before first IMP administration and must be willing to switch to the study IMP\n\nExclusion Criteria:\n\n* Meets the criteria for possible CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021)\n* Sensory CIDP (including sensory-predominant CIDP)\n* Polyneuropathy of other causes\n* Clinical diagnosis of systemic lupus erythematosus (SLE)\n* Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation",{"count":179,"type":22},160,[25],"The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo for 24 weeks (6 months). Following part A, participants will enter part B in which all participants will receive empasiprubart for 96 weeks (24 months).\n\nMore information can be found here: https:\u002F\u002Fclinicaltrials.argenx.com\u002Femnergize",[183,184,185],"Chronic Inflammatory Demyelinating Polyneuropathy","CIDP","Chronic Inflammatory Demyelinating Polyradiculoneuropathy",{"date":30,"type":33},{"date":188,"type":33},"2025-09-16",{"date":190,"type":22},"2031-01-23",{"name":192,"class":40},"argenx",78,{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":23,"phases":203,"briefSummary":204,"conditions":205,"keywords":206,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":218},"100595454","phase-2-imeroprubart-in-adult-participants-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp-100595454","NCT07032662","Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","Inclusion Criteria:\n\n* Have met clinical diagnostic criteria for typical CIDP or one of the following CIDP variants: multifocal CIDP or motor CIDP per the 2021 European Academy of Neurology\u002FPeripheral Nerve Society (EAN\u002FPNS) Guideline on Diagnosis and Treatment of CIDP.\n* Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN\u002FPNS guideline on diagnosis and treatment of CIDP.\n* Are currently on, and have been receiving chronic, stable doses of systemic corticosteroids (i.e., daily or every other day oral or pulse regimen), or immunoglobulin therapy (IVIg or SCIg) ± low dose oral corticosteroids for at least 3 months for the treatment of CIDP at the time of the Screening Visit.\n\nAdditional inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Have current or prior history of IgM paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies.\n* Have distal, sensory, or focal CIDP, or have a diagnosis of autoimmune nodopathy per the EAN\u002FPNS guideline on diagnosis and treatment of CIDP.\n* Have polyneuropathy of causes other than CIDP including but not limited to:\n\n  * Multifocal motor neuropathy\n  * Hereditary demyelinating neuropathy\n  * Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS)\n  * Lumbosacral radiculoplexus neuropathy\n  * Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies\n  * Drug- or toxin-induced\n* Have diabetes mellitus (DM) and meets any of the following criteria:\n\n  * Does not have both typical CIDP and strong evidence of demyelination on nerve conduction study.\n  * In the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP.\n  * In the opinion of the Investigator, there is evidence of poorly controlled DM at screening.\n* Have a history of myelopathy or evidence of central demyelination. Additional exclusion criteria are defined in the protocol.",{"count":202,"type":22},162,[154],"This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.",[183],[183,207,208,209,184,210],"IMVT-1402","Monoclonal antibody","Human immunoglobulin G1 (IgG1)","Imeroprubart",{"date":30,"type":33},{"date":213,"type":33},"2025-03-18",{"date":215,"type":22},"2030-05",{"name":217,"class":40},"Immunovant Sciences GmbH",141,{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":230,"conditions":231,"keywords":233,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":246},"100535501","phase-3-study-of-sotorasib-panitumumab-and-folfiri-versus-folfiri-with-or-without-bevacizumab-awwb-in-treatment-nave-participants-with-metastatic-colorectal-cancer-with-kras-pg12c-mutation-100535501","NCT06252649","Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation","Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)","CodeBreaK 301","Inclusion Criteria:\n\n* Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.\n* Central laboratory detection of KRAS p.G12C mutation.\n* Measurable metastatic disease per RECIST v1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Active, untreated brain metastases.\n* Leptomeningeal disease\n* Previous treatment with a KRAS p.G12C inhibitor\n* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan",{"count":228,"type":22},450,[25],"The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.",[232],"Metastatic Colorectal Cancer",[234,235,236,237,238],"Sotorasib","Panitumumab","FOLFIRI","Bevacizumab-awwb","Oncology",{"date":30,"type":33},{"date":241,"type":33},"2024-07-17",{"date":243,"type":22},"2032-04-25",{"name":245,"class":40},"Amgen",291,{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":23,"phases":258,"briefSummary":259,"conditions":260,"keywords":263,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":276},"100533520","phase-2-a-phase-2-study-to-evaluate-morf-057-in-adults-with-moderately-to-severely-active-crohns-disease-100533520","NCT06226883","A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease","A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)","GARNET","Key Inclusion Criteria:\n\n* Has signs\u002Fsymptoms of CD for at least 90 days prior to screening\n* Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and\u002For an average daily abdominal pain subscore of ≥2 points\n* Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)\n* Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants (eg, azathioprine, 6-mercaptopurine, methotrexate) and\u002For advanced therapies for CD (eg, biologic agents, Janus kinase \\[JAK\\] inhibitors, applicable investigational products)\n\nKey Exclusion Criteria:\n\n* Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC\n* Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement\n* Has had extensive bowel resection (\\>100 cm), and\u002For more than 3 resections, and\u002For has a known diagnosis of short bowel syndrome\n* Is currently receiving total parenteral nutrition, tube feeding, or a formula diet\n* Has positive findings on a subjective neurological screening questionnaire\n* Has a concurrent, clinically significant, serious, unstable comorbidity\n* Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors\n* Is currently participating in any other interventional study or has received any investigational therapy within 30 days\n* Previous exposure to MORF-057 and\u002For a known hypersensitivity to drugs with a similar mechanism to MORF-057\n* Unable to attend study visits or comply with study procedures\n* Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease","85 Years",{"count":257,"type":22},385,[154],"This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).",[261,262],"Inflammatory Bowel Diseases","Crohn's Disease",[264,265,266,267,268,253],"Crohn's disease (CD)","Inflammatory bowel disease (IBD)","a4b7","Moderate-to-severe","Integrin",{"date":30,"type":33},{"date":271,"type":33},"2024-07-18",{"date":273,"type":22},"2030-06",{"name":275,"class":40},"Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)",225,{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":23,"phases":286,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":297},"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":285,"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.",[289,290],"Metastatic Castration-resistant Prostate Cancer (mCRPC)","Prostatic Neoplasms",{"date":63,"type":33},{"date":293,"type":33},"2023-12-18",{"date":295,"type":22},"2030-12-02",{"name":141,"class":40},330,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":318},"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":307,"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.",[311],"Non-small Cell Lung Cancer",{"date":30,"type":33},{"date":314,"type":33},"2023-12-06",{"date":316,"type":22},"2035-12-21",{"name":141,"class":40},229,{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":326,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":329,"briefSummary":324,"conditions":330,"keywords":332,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":334,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":342},"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).","75 Years",{"count":328,"type":22},650,[25],[331],"Acute Myeloid Leukemia",[333],"adult patients",{"date":63,"type":33},{"date":336,"type":33},"2022-09-13",{"date":338,"type":22},"2032-02",{"name":340,"class":341},"University of Ulm","OTHER",91,{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":23,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":365},"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":352,"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.",[356],"Systemic Sclerosis","2026-08-19",{"date":161,"type":33},{"date":360,"type":33},"2026-07-27",{"date":362,"type":22},"2030-03-17",{"name":364,"class":40},"Boehringer Ingelheim",246,{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":17,"minAge":373,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":23,"phases":376,"briefSummary":377,"conditions":378,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":386},"100609861","phase-3-a-study-to-find-out-if-bi-764198-helps-adults-and-adolescents-with-a-kidney-condition-called-focal-segmental-glomerulosclerosis-fsgs-100609861","NCT07220083","A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)","A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial to Assess the Effects of Oral TRPC6 Inhibitor BI 764198 Taken Over a 104 Week Treatment Period in Adult and Adolescent Participants With Primary Focal Segmental Glomerulosclerosis (pFSGS) or Genetic FSGS Related to TRPC6 Gene Variants","Inclusion criteria:\n\n1. Male or female participants ≥12 years old on the day of signing informed consent\u002Fassent (Visit 1)\n2. Weight of ≥40 kg at the screening visit (Visit 1)\n3. Body mass index (BMI) of ≤40 kg\u002Fm² at the screening visit (Visit 1)\n4. Participants with a diagnosis prior to the screening visit (Visit 1) of either:\n\n   * Biopsy-confirmed primary focal segmental glomerulosclerosis (pFSGS) (based on Investigator's judgement) OR\n   * Genetic focal segmental glomerulosclerosis (FSGS) resulting from a gain-of-function mutation in the transient receptor potential cation subfamily C member 6 (TRPC6) gene (based on historical genetic test)\n5. Urine protein-creatinine ratio (UPCR) ≥1500 mg\u002Fg based on the mean of the spot urine sample and first morning void (FMV) urine sample (both assessed by central laboratory) at the screening visit (Visit 1)\n6. Estimated glomerular filtration rate (eGFR)\n\n   * For adult participants (≥18 years): ≥25 mL\u002Fmin\u002F1.73 m² (chronic kidney disease epidemiology collaboration (CKD-EPI) formula based on serum cystatin C) at the screening visit (Visit 1)\n   * For adolescent participants (12 to \\\u003C18 years): ≥25 mL\u002Fmin\u002F1.73 m² based on chronic kidney disease under 25 years (CKiD U25) formula using serum cystatin C at the screening visit (Visit 1) Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)\n2. Clinical or histologic evidence of secondary adaptive or toxic forms of FSGS (based on Investigator's judgement)\n3. FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator's judgement)\n4. A history of organ transplantation or planned organ transplantation during the course of the trial\n5. Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit 1) Further exclusion criteria apply.","12 Years",{"count":375,"type":22},286,[25],"PODOMOUNT-pFSGS\n\nThis study is open to adults and adolescents with a kidney condition called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 helps people with FSGS.\n\nParticipants are put into 2 groups randomly, which means by chance. Every participant has an equal chance of being in each group. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine.\n\nParticipants take a tablet once a day for up to 2 years. All participants also continue their standard medication for FSGS.\n\nParticipants are in the study for up to 2 years. During this time, they visit the study site about every 3 months. Participants regularly collect urine samples. This is done to check their kidneys. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[379],"Focal Segmental Glomerulosclerosis",{"date":161,"type":33},{"date":382,"type":33},"2026-02-16",{"date":384,"type":22},"2029-01-24",{"name":364,"class":40},306,{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":23,"phases":397,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":408},"100534422","phase-3-a-follow-up-study-to-test-long-term-treatment-with-nerandomilast-in-people-with-pulmonary-fibrosis-who-took-part-in-a-previous-study-with-nerandomilast-100534422","NCT06238622","A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast","An Open-label Extension Trial of the Long-term Safety and Efficacy of BI 1015550 Taken Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) (FIBRONEER™-ON)","FIBRONEER™-ON","Inclusion Criteria:\n\n1. Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)\n2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n3. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For France, fertile males must be ready and able to use acceptable methods of birth control\n\nExclusion Criteria:\n\n1. Any disease that may put the patient at risk when participating in this trial at investigator's discretion.\n2. Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1:\n\n   * any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)\n   * any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)\n3. Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore \\>14 at Visit 1.\n4. An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.\n5. Patient will undergo lung transplantation, with an assigned date of surgery.\n6. Patients with a Body Mass index (BMI) \\\u003C18.5 kg\u002Fm² that experienced an additional, unexplained and clinically significant (\\>10%) weight loss during the parent trial\n7. At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial\n8. Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.\n\nFurther exclusion criteria apply.",{"count":396,"type":22},1700,[25],"This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550.\n\nThe goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die.\n\nEvery participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study.\n\nParticipants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.",[400,401],"Idiopathic Pulmonary Fibrosis","Progressive Pulmonary Fibrosis",{"date":161,"type":33},{"date":404,"type":33},"2024-05-06",{"date":406,"type":22},"2027-05-05",{"name":364,"class":40},373,{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":23,"phases":418,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":430},"100629272","phase-3-dareon---lung-1-a-study-in-people-with-advanced-small-cell-lung-cancer-to-compare-obrixtamig-plus-atezolizumab-carboplatin-and-etoposide-treatment-with-standard-chemotherapy-100629272","NCT07472517","DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemoimmunotherapy","DAREON ® -Lung-1: A Phase III Multi-center, Open-label, Randomised Trial of Intravenous Obrixtamig in Combination With Atezolizumab, Carboplatin, and Etoposide vs. Atezolizumab, Carboplatin, and Etoposide as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer","Inclusion Criteria :\n\n1. Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (ES-SCLC)\n2. Patients without any previous systemic anti-cancer treatment for ES-SCLC. Patients who received previous systemic anti-cancer treatment during limited stage are eligible if the treatment has been completed more than 6 months before the diagnosis of ES-SCLC.\n3. Adequate archival formalin-fixed paraffin-embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status and other biomarkers. The central laboratory investigational VENTANA DLL3 (SP347) RxDx test result must be available prior to randomisation.\n4. Patients with asymptomatic brain metastasis are eligible if they meet one of the following criteria:\n\n   * Treatment for brain metastases (e.g. whole brain radiation therapy, stereotactic radiotherapy, or radiosurgery) completed at least 7 days prior to randomisation and the patient is neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 7 days prior to randomisation\n   * Untreated brain metastases that do not require treatment and the patient is neurologically stable without the use of glucocorticoids or therapeutic anti-convulsant for at least 28 days prior to randomisation\n5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n6. Eligible for continuing carboplatin + etoposide + atezolizumab regimen as first-line Standard of care (SoC) treatment within 28 days after the start of the initial cycle of standard therapy\n7. Eligible to receive treatment with full dose of atezolizumab, carboplatin, and etoposide as first-line SoC treatment, in accordance with the approved Summary of Product Characteristics if provided centrally or approved local product label if provided by the trial site Further inclusion criteria apply.\n\nExclusion Criteria :\n\n1. Presence of leptomeningeal disease and\u002For carcinomatous meningitis\n2. Previous treatment targeting DLL3 (e.g. T cell engagers (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)\n3. Radiotherapy of any anatomical site within 7 days prior to randomisation\n4. Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline. Patients with alopecia, any grade, CTCAE ≤Grade 2, asthenia\u002Ffatigue, amenorrhea\u002Fmenstrual disorders any grade, CTCAE Grade ≤2 peripheral neuropathy, and\u002For CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks prior to randomisation, per investigator judgment may be eligible. Note: Patients who developed toxicity from the cycle of standard therapy received prior to randomisation are eligible if adequate organ function is ensured as described\n5. Patient with active autoimmune disease or a documented history of autoimmune disease that requires systemic treatment (e.g. glucocorticoids or immunosuppressive drugs). Patients with vitiligo, resolved childhood asthma\u002Fatopy, alopecia, or any chronic skin condition that does not require systemic therapy, patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and\u002For controlled Type 1 diabetes mellitus on a stable insulin regimen may be included if in the opinion of the investigator it is appropriate and safe to do so.\n\nFurther exclusion criteria apply.",{"count":417,"type":22},670,[25],"This study is open to adults with advanced small cell lung cancer (SCLC). The purpose of this study is to find out if a study medicine called obrixtamig plus standard treatment (atezolizumab, carboplatin, and etoposide) improves survival when compared to standard treatment alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker DLL3.\n\nParticipants are put into 2 groups randomly, which means by chance. One group receives obrixtamig and standard treatment. The other group receives standard treatment without obrixtamig. All treatments are given as infusions into a vein.\n\nParticipants are in the study for up to 3 years. During this time, they visit the study site regularly. Participants in the group receiving obrixtamig stay overnight at the study site following the first 2 obrixtamig treatments. At the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[421,422],"Small Cell Lung Cancer (SCLC)","Extensive-stage Small Cell Lung Cancer (ES-SCLC)","2026-08-18",{"date":357,"type":33},{"date":426,"type":33},"2026-04-13",{"date":428,"type":22},"2029-07-30",{"name":364,"class":40},245,{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":17,"minAge":373,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":23,"phases":440,"briefSummary":441,"conditions":442,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":446,"leadSponsor":448,"locationsCount":449},"100620259","phase-2-podomount-basket-a-study-to-test-whether-bi-764198-helps-adults-and-adolescents-with-different-types-of-kidney-disease-100620259","NCT07355296","PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease","PODOMOUNT-Basket, a Phase II, Multicentre, Randomised, 2-arm Parallel-group, Double-blind, Placebo-controlled Basket Trial to Assess Safety, Tolerability, PK, and Efficacy of BI 764198 in Four Proteinuric Kidney Diseases","Inclusion Criteria:\n\n* Male or female participants ≥18 years of age (≥12 years of age for Treatment resistant primary Minimal Change Disease (TR-pMCD)) on the day of signing informed consent\u002Fassent (Visit 1)\n* Body Mass Index (BMI) of ≤40 kg\u002Fm2 at screening visit (Visit 1)\n* Weight of ≥40 kg at screening\n* Estimated glomerular filtration rate (eGFR) ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidney disease (CKD) EPI formula based on serum cystatin C) at screening visit\n\n  * For adult participants (≥18); ≥25 mL\u002Fmin\u002F1.73 m2 (CKD-EPI formula based on serum cystatin C) at the screening visit\n  * For adolescent participants (\\\u003C18); ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidey disease under 25 years (CKiD U25) formula using height and serum cystatin C) at the screening visit\n* Seated blood pressure (mean of 3 values) systolic blood pressure (SBP) ≤160 mmHg (adult participants ≥18) or SBP ≤140 mmHg (participants \\\u003C18) at the screening visit (Visit 1). A participant with a documented history of white coat hypertension may be included as long as the participant is considered medically stable by the investigator and \"true\" blood pressure can be considered to be ≤160 mmHg (adult participants ≥18) or ≤140 mmHg (adolescent participants \\\u003C18)\n* Participants should be treated with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), at a stable optimised dose for at least 8 weeks prior to the screening visit (Visit 1), with no plan to change the dose until the end of the randomised treatment period (i.e. end of trial (EoT), Week 20) unless not tolerated or indicated as per the discretion of the investigator\n* If treated with (non-steroidal) mineralocorticoid receptor antagonist (MRA), endothelin receptor antagonists (ERA), glucagon-like peptide-1 (GLP-1) or Sodium-glucose co-transporter-2 (SGLT2) inhibitors (SGLT2i), participants must be on a stable dose for at least 8 weeks prior to the screening visit (Visit 1), preferably with no plan to change the dose until the end of the randomised double-blind treatment period (i.e. EoT, Week 20)\n* Participants treated with oral immunosuppressive therapy except glucocorticoids (e.g. Calcineurin inhibitor(s) (CNI), mycophenolate mofetil\u002F-sodium, cyclophosphamide) must be on a stable dose for at least 12 weeks prior to the screening visit (Visit 1) with no plans to change their dose during the trial treatment period\n* Patients treated\u002Fto be treated with oral glucocorticoids have to be at a dose ≤10 mg\u002Fd prednisolone or equivalent for ≥4 weeks prior to screening with no plan to increase the dose during the treatment period.\n\nFurther inclusion criteria apply.\n\nExclusion Criteria:\n\n* A history of organ transplantation or planned transplantation during the course of the study\n* Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the past 6 months prior to screening visit (Visit 1)\n* Participants in whom initiation of oral or IV immunosuppression is anticipated during the course of the trial\n* Treatment with metformin or dofetilide (multidrug and toxin extrusion protein 1 (MATE1) substrates) within one week prior to randomisation visit (Visit 2) through 5 days after the EoT visit\n* Treatment with strong inhibitors or strong inducers of cytochrome P450 3A4\u002F5 (CYP3A4\u002F5) within one week or 5 half-lives (whichever is longer) prior to randomisation visit (Visit 2)\n* Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\>3X the upper limit of normal (ULN) at screening visit (Visit 1)\n* Clinically significant laboratory abnormalities or medical conditions which pose a safety risk for the participant or may interfere with the trial objectives in the investigator's opinion (except for renal function tests or deviation of clinical laboratory values that are related to the podocytopathy in question) at screening visit\n* QTc intervals (QTcF) greater than 450 ms in males or greater than 470 ms in females, or any other clinically relevant ECG findings (at the investigator's discretion) at screening visit (Visit 1) Further exclusion criteria apply.",{"count":439,"type":22},132,[154],"This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group.\n\nParticipants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[443],"Proteinuric Kidney Diseases",{"date":357,"type":33},{"date":35,"type":33},{"date":447,"type":22},"2028-02-17",{"name":364,"class":40},163,{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":23,"phases":460,"briefSummary":462,"conditions":463,"keywords":465,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":478},"100383674","landmark-trial-a-randomised-controlled-trial-of-myval-thv-100383674","NCT04275726","LANDMARK Trial: a Randomised Controlled Trial of Myval THV","A Prospective, Multinational, Multicentre, Open-label, Randomised, Non-inferiority Trial to Compare Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series vs. Contemporary Valves (Edwards's Sapien THV Series and Medtronic's Evolut THV Series) in Patients With Severe Symptomatic Native Aortic Valve Stenosis","LANDMARK","Inclusion Criteria:\n\n1. Patient ≥18 years of age.\n2. Patient or their legal representative has provided written informed consent as approved by the Institutional Review Board (IRB)\u002FInstitutional Ethics Committee (IEC) of the investigational site to participate in the study.\n3. As per local Heart Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices.\n\nExclusion Criteria:\n\n1. Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study.\n2. Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.",{"count":459,"type":22},988,[461],"NA","The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis.\n\nThis study will be done in total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves)\n\nThe randomisation will be carried out with an allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series)",[464],"Aortic Valve Stenosis",[466,467,468],"LANDMARK Trial","Trial to evaluate safety & effectiveness of Myval THV","CE Approved Myval THV Series","2026-08-13",{"date":471,"type":33},"2026-08-17",{"date":473,"type":33},"2020-11-04",{"date":475,"type":22},"2033-12-31",{"name":477,"class":40},"Meril Life Sciences Pvt. Ltd.",54,{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":17,"minAge":486,"maxAge":487,"enrollmentInfo":488,"targetDuration":4,"studyType":23,"phases":490,"briefSummary":491,"conditions":492,"keywords":494,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":515},"100386119","phase-3-a-treatment-study-protocol-for-participants-0-45-years-with-acute-lymphoblastic-leukaemia-100386119","NCT04307576","A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia","ALLTogether1 - A Treatment Study Protocol of the ALLTogether Consortium for Children and Young Adults (0-45 Years of Age) With Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL)","Inclusion Criteria:\n\n* Patients newly diagnosed with T-lymphoblastic (T-cell) or B-lymphoblastic precursor (BCP) leukaemia (ALL) according to the WHO-classification of Tumours of Haematopoetic and Lymphoid Tissues (Revised 4th edition 2017) and with a diagnosis confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.\n* Age 0 - \\\u003C 46 years (one day before 46th birthday) at the time of diagnosis with the exception of infants with KMT2A-rearranged (KMT2A-r) BCP ALL.\n* Patients with surface immunoglobulin negative (sIG-) BCP-ALL and an IG::MYC rearrangement, unless they have a concurrent BCL2\u002F6 rearrangement. T-ALL patients with MYC translocations.\n* Informed consent signed by the patient and\u002For parents\u002Flegal guardians according to country-specific age-related guidelines.\n* The ALL diagnosis should be confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.\n* The patient should be diagnosed and treated at a participating paediatric oncology or adult haematology centre in the participating countries.\n* The patient should be a resident in one of the participating countries on a permanent basis or should intend to settle in a participating country, for instance by an application for asylum. Patients who are visiting the country as tourists should not be included. However, returning expatriots with primary diagnosis abroad may be included if no treatment has been administered and the diagnostic procedures are repeated at a participating centre.\n* All women of childbearing potential (WOCBP) have to have a negative pregnancy test within 2 weeks prior to the start of treatment.\n* For each intervention\u002Frandomisation an additional set of inclusion-criteria is provided.\n\nExclusion Criteria:\n\n* Age \\\u003C 365 days and KMT2A-rearranged (KMT2A-r) BCP-ALL (documented presence of a KMT2A-split by FISH and\u002For a KMT2A fusion transcript).\n* Age \\>45 years at diagnosis.\n* Patients with a previous malignant diagnosis (ALL as a second malignant neoplasm - SMN).\n* Relapse of ALL.\n* Patients with mature B-ALL (as defined by surface IG positivity) or any patients with IG::MYC and a concurrent BCL2\u002F6 rearrangement.\n* Patients with Ph-positive ALL (documented presence of t(9;22)(q34;q11) and\u002For of the BCR::ABL fusion transcript). These patients will be transferred to an appropriate trial for t(9;22) if available.\n* Previously known ALL prone syndromes (e.g. Li-Fraumeni syndrome, germline ETV6 mutation), except for Down syndrome. Exploration for such ALL prone syndromes is not mandatory and patients in whom genetic work-up reveals a new germ-line mutation (index-cases) will remain in the study.\n* Treatment with systemic corticosteroids corresponding to (\\>10mg prednisolone\u002Fm2\u002Fday) for more than one week and\u002For other chemotherapeutic agents in a 4-week interval prior to diagnosis (pre-treatment).\n* Pre-existing contraindications to any treatment according to the ALLTogether protocol (constitutional or acquired disease prior to the diagnosis of ALL preventing adequate treatment).\n* Any other disease or condition, as determined by the investigator, which could interfere with the participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures.\n* Women of childbearing potential who are pregnant at the time of diagnosis.\n* Women of childbearing potential and fertile men who are sexually active and are unwilling to use adequate contraception during therapy. Efficient birth control is required.\n* Female patients, who are breast-feeding.\n* Essential data missing from the registration of characteristics at diagnosis (in consultation with the protocol chair).\n* For each intervention\u002Frandomisation an additional set of exclusion-criteria is provided.","0 Years","45 Years",{"count":489,"type":22},6430,[25],"ALLTogether collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new master protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised and interventional trials included in the study-design.",[493],"Leukemia, Acute Lymphoblastic",[495,496,17,497,498,499,500,501,502,503,504,505],"Leukemia","Acute Leukemia","ALLTogether","Leukaemia","Inotuzumab ozogamicin","Besponsa","ALLTogether1","Blinatumomab","Blincyto","6-tioguanine","6-thioguanine","2026-08-11",{"date":508,"type":33},"2026-08-12",{"date":510,"type":33},"2020-07-13",{"date":512,"type":22},"2033-06",{"name":514,"class":341},"Mats Heyman",137,{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":17,"minAge":486,"maxAge":487,"enrollmentInfo":523,"targetDuration":4,"studyType":525,"phases":4,"briefSummary":526,"conditions":527,"keywords":528,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":534,"locationsCount":535},"100355680","a-treatment-protocol-for-participants-0-45-years-with-acute-lymphoblastic-leukaemia-100355680","NCT03911128","A Treatment Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia","A Treatment Study Protocol of the ALLTogether Consortium for Infants, Children and Young Adults (0-45 Years of Age) With Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL): a Pilot Study","Inclusion Criteria:\n\n* Patients newly diagnosed with T-lymphoblastic (T-cell) or B-lymphoblastic precursor (BCP) leukaemia (ALL) according to the WHO-classification of Tumours of Haematopoietic and Lymphoid Tissues (Revised 4th edition 2017) and with a diagnosis confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.\n* Age 0 - \\\u003C 46 years (one day before 46th birthday) at the time of diagnosis, with the exception of infants with KMT2A-r BCP ALL (see exclusion criteria below).\n* Patients with surface immunoglobulin negative (sIG-) BCP-ALL and an IG::MYC rearrangement, unless they have a concurrent BCL2\u002F6 rearrangement. T-ALL patients with MYC translocations.\n* Informed consent signed by the patient and\u002For parents\u002Flegal guardians according to country-specific age related guidelines\n* The ALL diagnosis should be confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.\n* The patient should be diagnosed and treated at a participating paediatric oncology or adult haematology centre in the participating countries.\n* The patient should be a resident in one of the participating countries on a permanent basis or should intend to settle in a participating country, for instance by an application for asylum. Patients who are visiting the country as tourists should not be included. However, returning expatriots and patients who intend to stay at least for the duration of the treatment with primary diagnosis abroad may be included if no treatment has been administered and the diagnostic procedures are repeated at a participating centre.\n* All women of childbearing potential (WOCBP) have to have a negative pregnancy test within 2 weeks prior to the start of treatment.\n\nExclusion Criteria:\n\n* Age \\\u003C 365 days and KMT2A-rearranged (KMT2A-r) BCP-ALL (documented presence of a KMT2A-split by FISH and\u002For a KMT2A fusion transcript). These patients will be transferred to an appropriate trial for infant KMT2A-r BCP-ALL, if available.\n* Age \\>45 years at diagnosis.\n* Patients with a previous malignant diagnosis (ALL as a second malignant neoplasm - SMN).\n* Relapse of ALL.\n* Patients with mature B-ALL (as defined by surface IG positivity) or any patients with IG::MYC and a concurrent BCL2\u002F6 rearrangement.\n* Patients with Ph-positive ALL (documented presence of t(9;22)(q34;q11) and\u002For of the BCR::ABL1 fusion transcript). These patients will be transferred to an appropriate trial for t(9;22) if available.\n* Previously known ALL prone syndromes (e.g. Li-Fraumeni syndrome, germline ETV6 mutation), except for Down syndrome. Exploration for such ALL prone syndromes is not mandatory and patients in whom genetic work-up reveals a new germ-line mutation (index-cases) will remain in the study.\n* Treatment with systemic corticosteroids corresponding to (\\>10mg prednisolone\u002Fm2\u002Fday) for more than one week and\u002For other chemotherapeutic agents in a 4-week interval prior to diagnosis (pre-treatment).\n* Pre-existing contraindications to any treatment according to the ALLTogether protocol (constitutional or acquired disease prior to the diagnosis of ALL preventing adequate treatment).\n* Any other disease or condition, as determined by the investigator, which could interfere with the participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures.\n* Women of childbearing potential who are pregnant at the time of diagnosis.\n* Women of childbearing potential and fertile men who are sexually active and are unwilling to use adequate contraception during therapy. Efficient birth control is required, see section 18.9.\n* Female patients, who are breast-feeding.\n* Essential data missing from the registration of characteristics at diagnosis (in consultation with the protocol chair).",{"count":524,"type":22},500,"OBSERVATIONAL","The pilot study collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new platform protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised trials included in the study-design.\n\nThe pilot study is implemented as a master protocol without study specific interventions, thus as an observational study. The pilot study is for countries\u002Fstudy-groups who intend to join ALLTogether1 (including experimental interventions). For these countries the pilot study is crucial to optimise diagnostics, registration systems, collaborations with vendors, logistics and data-checks before starting the main study.\n\nThe study only includes \"standard of care\" treatment included in the master protocol.",[493],[495,529,17,497,498],"Acute Lymphoblastic",{"date":469,"type":33},{"date":532,"type":33},"2019-08-29",{"date":512,"type":22},{"name":514,"class":341},57,{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":23,"phases":546,"briefSummary":547,"conditions":548,"keywords":550,"overallStatus":555,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":564},"100651277","phase-2-teclistamab-in-combination-with-pomalidomide-administered-in-alternative-fashion-in-participants-with-relapsed-or-refractory-multiple-myeloma-100651277","NCT07757412","Teclistamab in Combination With Pomalidomide Administered in Alternative Fashion in Participants With Relapsed or Refractory Multiple Myeloma.","A Phase II, Open-label, Multicenter Study Testing Teclistamab in Combination With Pomalidomide Administered in Alternative Fashion in Participants With RRMM, Who Received 1 - 3 Prior Lines of Therapy, Including Lenalidomide and Anti-CD38 Therapy.","ADAPTATION","Inclusion Criteria:\n\n1. ≥18 years of age (or the legal age of majority, if greater than 18, in the jurisdiction in which the study is taking place) at the time of informed consent.\n2. Documented diagnosis of multiple myeloma as defined by the criteria below:\n\n   1. Multiple myeloma diagnosis according to IMWG diagnostic criteria.\n   2. Measurable disease at screening as defined by any of the following:\n\n      1. Serum M-protein level ≥0.5 g\u002FdL; or Serum Ig FLC ≥10 mg\u002FdL and abnormal serum Ig kappa lambda FLC ratio.\n3. Relapsed or refractory disease as defined below : a. Relapsed disease is defined as an initial response to previous treatment, followed by confirmed progressive disease by IMWG criteria \\>60 days after cessation of treatment. b. Refractory disease is defined as failure to achieve a response or confirmed progressive disease by IMWG criteria during previous treatment or ≤60 days after cessation of treatment.\n4. Received 1-3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti-CD38 monoclonal antibody at the approved dosing schedule (or minimum of 6 doses if anti-CD38 monoclonal antibody was only part of a maintenance regimen) in any prior line and 2 consecutive cycles of lenalidomide in any prior line. NOTE: A single line of therapy may consist of 1 or more agents and may include induction, hematopoietic stem cell transplantation and maintenance therapy. Radiotherapy, bisphosphonates, or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 mg\u002Fday for 4 days) would not be considered prior lines of therapy.\n5. Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by IMWG criteria.\n6. Have an ECOG performance status score of 0 to 2\n7. Have clinical laboratory values meeting the protocol criteria during the Screening Phase.\n8. A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test within 14 days prior to first dose and again a negative serum pregnancy test within 24 hours of the start of study treatment and must agree to further serum pregnancy tests during the study.\n9. A female participant must be either of the following a. Not of childbearing potential, or b. Of childbearing potential and practicing at least 1 highly effective method of contraception.\n10. A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for a period of 6 months after\n11. A male participant must wear a condom (with or without spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 3 months after receiving the last dose of study treatment. If a male participant's partner is a female of childbearing potential, the male participant must use condoms (with or without spermicide) and the female partner of the male participant must also be practicing a highly effective method of contraception.\n12. A male participant must agree not to donate sperm for the purpose of reproduction during the study and a period of 3 months after receiving the last dose of study treatment. Male participants should consider preservation of sperm prior to study treatment as anti-cancer treatments may impair fertility.\n13. Must sign an ICF (or their legally designated representative must sign in accordance with local legislation) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n14. Must be willing and able to adhere to the lifestyle restrictions specified in this protocol.\n\nExclusion Criteria:\n\nAny potential participant who meets any of the following criteria will be excluded from participating in the study:\n\n1. Received any prior BCMA-directed therapy.\n2. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the teclistamab IB and appropriate prescribing information).\n3. Participants will be excluded if intolerant to dexamethasone.\n4. Received the following prior antimyeloma therapy, within the specified time frame prior to enrollment:\n\n   1. Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less\n   2. Investigational vaccine within 4 weeks\n   3. Monoclonal antibody therapy within 21 days\n   4. Cytotoxic therapy within 21 days\n   5. PI therapy within 14 days\n   6. IMiD agent therapy within 14 days\n   7. Radiotherapy within 14 days or focal radiation within 7 days\n   8. Gene-modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells) within 3 months\n   9. Plasmapheresis within 28 days\n   10. Received a maximum cumulative dose of corticosteroids of ≥140 mg of prednisone or equivalent within 14 days\n   11. Stem cell transplant within 6 months. Participants who received an\n5. Received a live, attenuated vaccine within 4 weeks of enrollment or if participant plans to receive such vaccines during the study. Non-live or non replicating vaccines authorized for emergency use are allowed.\n6. CNS involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology may be required.\n7. Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis.\n8. Excluded for any of the following:\n\n   1. Any ongoing myelodysplastic syndrome.\n   2. Any history of malignancy, other than multiple myeloma, which is considered at high risk of recurrence requiring systemic therapy.\n   3. Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured: Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, \\\u003C3 cm, no CIS), Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone.,Non-invasive cervical cancer, Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer (anti-hormonal therapy is permitted), Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP\u002FRT\u002Ffocal treatment), Other malignancy that is considered cured with minimal risk of recurrence in consultation with the sponsor.\n9. Stroke, transient ischemic attack, or seizure within 6 months prior to enrollment.\n10. Presence of the following cardiac conditions.\n\n    a. Unstable angina or New York Heart Association class III or IV congestive heart failure, b. Myocardial infarction or coronary artery bypass graft ≤6 months prior to enrollment,c. History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration, d. Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities, e. TTE or MUGA scan showing left ventricular ejection fraction \\\u003C40%\n11. Participant had major surgery or had significant traumatic injury within 2 weeks prior to enrollment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study.\n\n    NOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery. If there is a question whether a procedure is considered a major surgery, the investigator must consult with the appropriate sponsor representative and resolve any issues before enrolling a participant in the study.\n12. Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or constitute a hazard for participating in the study (ie, those listed below) or any others that in the opinion of the investigator would constitute a hazard for participating in this study, such as: a. Acute diffuse infiltrative pulmonary disease or diagnosis of pulmonary hypertension. b. Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic antimicrobial therapy.\n\n    c. Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment. Exception: Participants with vitiligo. controlled type I diabetes, and prior autoimmune thyroid disease that is currently euthyroid based on clinical symptoms and laboratory testing are eligible regardless of when these conditions were diagnosed. Eligibility for participants with any other autoimmune disease(s) should be discussed with the medical monitor\u002Fsponsor. d. Disabling psychiatric conditions (eg, alcohol or drug abuse), severe dementia, or altered mental status. e. History of non-compliance with recommended medical treatments. f. Intolerance to hydration due to pre-existing pulmonary or cardiac impairment. g. Pleural effusions requiring thoracentesis within 14 days prior to enrollment. Ascites requiring paracentesis within 14 days prior to enrollment.\n13. Seropositive for hepatitis B: defined by a positive test for HbsAg. Participants with resolved infection (ie, participants who are HbsAg negative with antibodies to total anti-HBc with or without the presence of anti-HBs) must be screened using RT-PCR measurement of HBV-DNA levels. Participants with a known history of HBV infection must be screened using RT-PCR measurement of HBV-DNA levels irrespective of serological results. Those who have detectable HBV-DNA levels by RT-PCR will be excluded. Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV-DNA by RT-PCR.\n14. Active hepatitis C infection as measured by detectable HCV-RNA testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic hepatitis C infection (defined as both HCV antibody and HCV-RNA positive) completed antiviral therapy and has undetectable HCV-RNA 12 weeks following the completion of therapy, the participant is eligible for the study.\n15. Human immunodeficiency virus-positive with 1 or more of the following:\n\n    1. History of AIDS-defining conditions\n    2. CD4+ count \\\u003C350 cells\u002Fmm3 during screening\n    3. Detectable viral load during screening or within 6 months prior to screening\n    4. Not receiving highly active antiretroviral therapy\n    5. Had a change in antiretroviral therapy within 6 months of the start of screening\n    6. Receiving antiretroviral therapy that may interfere with study treatment as assessed after discussion with the sponsor.\n16. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.",{"count":545,"type":22},50,[154],"This Phase II, open-label, multicenter study will evaluate teclistamab in combination with pomalidomide administered using an alternative dosing approach in participants with relapsed or refractory multiple myeloma who have received 1-3 prior lines of therapy, including lenalidomide and anti-CD38 therapy. Teclistamab is a bispecific antibody that targets BCMA on myeloma cells and CD3 on T cells, bringing these cells into close proximity and activating T cells to induce targeted killing of BCMA-expressing myeloma cells. The study will assess the safety and efficacy of this treatment combination in participants with relapsed or refractory multiple myeloma.",[549],"Multiple Myeloma Progression",[551,552,553,554],"Multiple myeloma","Teclistamab","Pomalidomid","T-cell-engaging bispecific antibody","NOT_YET_RECRUITING","2026-08-07",{"date":506,"type":33},{"date":559,"type":22},"2026-09-01",{"date":561,"type":22},"2032-01-01",{"name":563,"class":341},"Odense University Hospital",9,{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":23,"phases":574,"briefSummary":575,"conditions":576,"keywords":578,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":583,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":590},"100567691","phase-3-a-study-of-zasocitinib-in-adults-with-psoriatic-arthritis-who-have-not-taken-biologic-medicines-100567691","NCT06671483","A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines","A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001)","Inclusion Criteria:\n\nAge:\n\n1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF). In South Korea, the age requirement for adult participants is \\>=19 years of age.\n\n   Disease Characteristics:\n2. The participant has a diagnosis of PsA.\n3. The participant must have signs and symptoms of PsA for at least 3 months prior to screening.\n4. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).\n5. The participant has active arthritis as shown by a minimum of \\>=3 tender joints in TJC68 and \\>=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.\n6. The participant has at least 1 active lesion of plaque PsO \\>=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.\n\n   Medications for PsA:\n7. The participant has had at least one of the following:\n\n   1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union \\[EU\\]\u002F European Economic Area \\[EEA\\]), OR\n   2. Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD).\n\nExclusion Criteria:\n\nPsA and PsO:\n\n1. The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.\n2. The participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).",{"count":573,"type":22},1088,[25],"Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO).\n\nThe main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs.\n\nThe participants will be treated with either zasocitinib, active comparator, or placebo. Participants will be in the study for up to 60 weeks.",[577],"Psoriatic Arthritis",[579,580,581,582],"Drug Therapy","Latitude Research Program","Latitude PsA","Latitude PsA-3001",{"date":506,"type":33},{"date":585,"type":33},"2025-03-03",{"date":587,"type":22},"2028-01-28",{"name":589,"class":40},"Takeda",188,{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":598,"targetDuration":4,"studyType":23,"phases":600,"briefSummary":601,"conditions":602,"keywords":603,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":618},"100610148","phase-3-bleximenib-in-combination-with-standard-induction-and-consolidation-therapy-followed-by-maintenance-for-treatment-of-patients-with-acute-myeloid-leukemia-aml-100610148","NCT07223814","Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML)","Bleximenib or Placebo in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for the Treatment of Patients With Newly Diagnosed KMT2A-rearranged or NPM1-mutant Acute Myeloid Leukemia Eligible for Intensive Chemotherapy: a Double-blind Phase 3 Study","Inclusion Criteria:\n\n1. ≥18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater) at the time of informed consent.\n2. New diagnosis of AML (≥10% blasts in BM or peripheral blood) with mutated NPM1 or with recurring rearrangements involving KMT2A according to ICC 2022 criteria.\n3. Considered eligible for intensive chemotherapy.\n4. WHO\u002FECOG performance status ≤2.\n5. Adequate renal and hepatic functions prior to randomization.\n\nExclusion Criteria:\n\n1. Prior (chemo-)therapy for AML, including prior treatment with hypomethylating agents\n2. Known active leukemic involvement of the central nervous system (CNS).\n3. Recipient of solid organ transplant.\n4. Cardiac disease:\n\n   1. Any of the following within 6 months of randomization: myocardial infarction, uncontrolled\u002Funstable angina, congestive heart failure (NYHA Class III or IV), uncontrolled or symptomatic arrhythmias, stroke, or transient ischemic attack.\n   2. QTc interval using Fridericia's formula (QTcF) ≥470 ms. Prolonged QTc interval associated with bundle branch block or pacemaking is permitted.\n   3. Left ventricular ejection fraction (LVEF) \\\u003C40% by ECHO or MUGA scan obtained within 28 days prior to the start of study treatment.\n   4. Previously received cumulative dose of any combination of anthracyclines or anthracenediones of ≥500 mg\u002Fm2.\n5. Chronic respiratory disease requiring supplemental oxygen.",{"count":599,"type":22},875,[25],"The current standard of care treatment for adult patients with acute myeloid leukemia (AML) consists of chemotherapy and, if indicated, donor stem cell transplantation.\n\nBleximenib blocks the interaction between a protein called menin and another protein called KMT2A in the leukemia cells. When this interaction is disrupted in AML with mutations in the NPM1 or KMT2A gene, bleximenib can cause leukemia cells to die.\n\nThe main objective is to assess if treatment with bleximenib, when added to chemotherapy treatment will improve treatment outcome in adult participants with newly diagnosed AML who present with mutations in the NPM1 or KMT2A genes.\n\nThis is a randomized, double-blind, placebo-controlled, phase 3 clinical trial. All of the participants will receive standard chemotherapy treatment, combined with either bleximenib or a placebo. A placebo is a substance that looks like the study medicine but has no active ingredients (e.g., a sugar pill). In a double blind trial neither the participant nor the doctor know if placebo or active study drug is given.\n\nAfter the end of the protocol treatment there will be an observational follow-up of 4 years from the time of inclusion of the last patient. The results of the different treatment groups will be compared.\n\n875 previously untreated patients with AML with a specific change in the DNA of the leukemia cells (a KMT2A rearrangement or a NPM1 mutation) will be included. Participants must be 18 years or older and considered eligible for intensive chemotherapy.",[331],[604,605,606,607,608],"AML","adult","newly diagnosed AML","NPM1","KMT2A","2026-08-05",{"date":611,"type":33},"2026-08-06",{"date":613,"type":33},"2026-03-01",{"date":615,"type":22},"2033-12",{"name":617,"class":341},"Stichting Hemato-Oncologie voor Volwassenen Nederland",63,{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":23,"phases":627,"briefSummary":628,"conditions":629,"keywords":631,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":640,"locationsCount":641},"100566227","phase-3-revumenib-in-combination-with-azacitidine--venetoclax-in-patients-npm1-mutated-or-kmt2a-rearranged-aml-100566227","NCT06652438","Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML","Randomized Study to Assess Revumenib in Combination With Azacitidine + Venetoclax in Adult Patients With Newly Diagnosed NPM1-mutated or KMT2A-rearranged AML Ineligible for Intensive Chemotherapy","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a patient must meet all of the following criteria:\n\n1. Patient with newly diagnosed NPM1-mutated AML, consistent with NPM1c, according to the 2022 International Consensus Classification (i.e. ≥ 10% blasts).\n\n   OR Patient with newly diagnosed KMT2A-rearranged AML according to the 2022 International Consensus Classification (i.e. ≥ 10% blasts). KMT2A partial tandem duplications or deletions are NOT eligible.\n\n   Of note: in case both NPM1 and IDH1 are mutated and both EVOLVE-1 (HO173) and EVOLVE-2 (HO177) are open for inclusion at your site, then patients can only be included in the EVOLVE-1 trial (HO173)\n2. Central confirmation of NPM1 mutation or KMT2A rearrangement in one of the dedicated central genetic laboratories.\n3. Age ≥ 18 years, no upper age limit.\n4. Patient is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria:\n\n   * ≥ 75 years of age: ineligible for intensive chemotherapy per physician's discretion (with an ECOG performance status 0-2) .\n   * 18-74 years: patient is not eligible for standard chemotherapy because any of the following co-morbidities:\n\n     * ECOG performance status 2 or 3 .\n     * Cardiac history of chronic heart failure requiring treatment; or with an ejection fraction ≤50%; or chronic stable angina.\n     * DLCO ≤ 65% or FEV1 ≤ 65%.\n     * Creatinine clearance ≥ 30 mL\u002Fmin to \\\u003C45 ml\u002Fmin calculated by the Cockcroft Gault formula.\n     * Moderate hepatic impairment with total bilirubin \\> 1.5 to \\\u003C 3.0 x upper limit of normal (ULN).\n     * Any other comorbidity that the local physician assesses to be incompatible with intensive chemotherapy must be reviewed and approved by the Sponsor's (co-) Principal Investigator (written approval must be sent to HO177@erasmusmc.nl before study enrolment).\n5. Patient must have a projected life expectancy of at least 12 weeks (as assessed by the treating physician).\n6. Patient must have a white cell blood (WBC) count of \\\u003C 25 x 109\u002FL. Hydroxyurea can be used prior to study enrolment to reduce the WBC count to meet this criterion.\n7. Adequate renal function as evidenced by serum creatinine ≤ 2.0 × upper limit of norm (ULN) or creatinine clearance \\>30 mL\u002Fmin based on the Cockcroft-Gault glomerular filtration rate (GFR).\n8. Adequate hepatic function as evidenced by:\n\n   * Serum total bilirubin ≤ 3.0 × ULN unless considered due to Gilbert's disease, or leukemic involvement following written approval by the sponsor (Co-)Principal Investigator (copy in HO177@erasmusmc.nl).\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to leukemic involvement following written approval by the sponsor (Co-)Principal Investigator (copy in HO177@erasmusmc.nl).\n9. Female patient must:\n\n   * be of nonchildbearing potential: o postmenopausal (defined as at least 1 year without any menses). o 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) agree to avoid pregnancy during the study and for 6 months after the final study drug administration.\n\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 6 months after the final study drug administration.\n\n       \\*Highly effective forms of birth control include\n\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\n       \\- Established intrauterine device (IUD) or intrauterine system (IUS)\n\n       \\- Bilateral tubal occlusion\n\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\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   * agree not to breastfeed starting at screening and throughout the study period.\n   * agree not to donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.\n10. Men must use a latex condom during any sexual contact with women of childbearing potential (WOCBP), even if they have undergone a successful vasectomy and must agree to avoid to father a child (while on therapy and for 6 months after the final study drug administration). In addition, their female partners of childbearing potential must use a highly effective method of birth control.\n11. Male patient must not donate sperm starting at screening and throughout the study period and for 6 months after the final study drug administration.\n12. Able to understand and willing to sign an informed consent form (ICF).\n13. Institutional Review Board\u002FIndependent Ethics Committee-approved written informed consent as per national regulations must be obtained from the patient prior to any study-related procedures (including consent for withdrawal of prohibited medication, if applicable).\n\nExclusion Criteria:\n\nSubject has previously been treated for AML; a treatment period with hydroxyurea to control WBC counts is allowed; prior treatment with a hypomethylating agent for MDS-EB is not allowed; prior treatment with erythropoiesis-stimulating agents or luspatercept for MDS is allowed.\n\n2\\. Acute promyelocytic leukemia (APL) with t(15;17)(q24.1;q21.2); PML-RARA; or one of the other pathognomonic variant chromosomal translocations \u002F fusion genes. 3. AML with BCR-ABL1; or myeloid blast crisis of CML. 4. Significant active cardiac disease within 3 months prior to the start of study treatment, including:\n\n* New York Heart Association (NYHA) class III or IV congestive heart failure\n* Myocardial infarction\n* Unstable angina\n* Severe cardiac arrhythmias\n* Congenital long QT syndrome of family member with this condition QTcF \\>450 msec on screening electrogram for males and \\>470msec on screening electrogram for females (mean of triplicate recordings; calculated using Fridericia's correction). 5. Severe obstructive or restrictive ventilation disorder. 6. History of stroke or intracranial hemorrhage within 6 months prior to randomization.\n\n  7\\. Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid (CSF) during screening is only required if there is a clinical suspicion of CNS involvement by leukemia during screening. 8. Active infection, including hepatitis B or hepatitis C or Human Immunodeficiency Virus (HIV) infection, that is uncontrolled prior to first dose of study treatment and may interfere with the study objectives or which could expose the patient to undue risk through the participation in the clinical trial; an infection controlled with an approved antibiotic\u002F antiviral\u002F antifungal treatment that is not a strong or moderate CYP3A inducer is allowed. Patients with COVID-19 infection can be enrolled, if the patient has no symptoms and was tested negative twice by PCR test prior to inclusion in the trial. 9. Immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding and\u002For disseminated intravascular coagulation. 10. Conditions that limit the ingestion or gastrointestinal absorption of orally administered drugs.\n\n  11\\. Patient with a currently active second malignancy. Patients are not considered to have a currently active malignancy, if they have completed therapy and are considered by their physician to be at \\\u003C 30% risk of relapse within one year. However, patients with the following history\u002Fconcurrent conditions are allowed:\n* Basal or squamous cell carcinoma of the skin;\n* Carcinoma in situ of the cervix;\n* Carcinoma in situ of the breast;\n* Incidental histologic finding of prostate cancer. 12. Receipt of live, attenuated vaccine within 30 days prior to the study inclusion (NOTE: patient, if enrolled, should not receive live vaccine during the study and until 6 months after the therapy).\n\n  13\\. Severe neurological or psychiatric disorder interfering with ability to give an informed consent.\n\n  14\\. Contraindication to AZA or VEN (as per Summary of Product Characteristics (SmPC)).\n\n  15\\. Patient weighing \\\u003C40 kg at registration. 16. Participation in other prospective studies with anti-leukemic and\u002For investigational agents.\n\n  17\\. Patient taking Dabigatran unless they can be transferred to other medications within ≥5 half-lives prior to dosing. Patients taking other P-gP transporter-sensitive medications (see Appendix H) should be properly monitored during the study if they cannot be transferred to other medications.\n\n  18\\. Patient taking known strong cytochrome P450 (CYP) 3A4 inducers (see Appendix G), unless they can be transferred to other medications within ≥5 half-lives prior to dosing.\n\n  19\\. The patient is a pregnant or lactating woman, or plans to become pregnant during the study.\n\n  20\\. Patient who has once been screened and randomized into this HO177 trial but was considered ineligible cannot re-enter this trial at a later date.",{"count":352,"type":22},[25],"Treatment of patients with newly diagnosed AML who are not eligible for intensive chemotherapy has remained an area of high unmet medical need. The combination therapy with two medicines, azacitidine and venetoclax, is the usual plan of action. This has brought significant progress in the treatment, but it nevertheless is not curative and the disease does relapse over time.\n\nRevumenib blocks a specific molecule called menin in the cell nucleus. Some types of AML are reliant on menin working properly. These are leukemia cells with a change in the DNA, i.e. a mutation in the NPM1 or KMT2A gene. Revumenib can prevent the production of these types of leukemia cells by disrupting the production of this menin.\n\nThe current study investigates whether adding revumenib to the combination therapy improves the prognosis for AML patients with a mutation in the NPM1 or KMT2A gene.\n\nThis is a randomized, double-blind, placebo-controlled clinical study where subjects will be treated until disease progression, or development of side effects or death. From the moment of inclusion of the last patient, there will be a 4-year observational follow-up study in order to register survival duration and follow-up visits.\n\nApproximately 448 previously untreated patients with a mutation in the NPM1 or KMT2A gene and with newly diagnosed AML, who are not eligible for intensive chemotherapy. Patients must be ≥18 years of age.",[630],"Acute Myeloid Leukemia, Adult",[632,607,608],"newly AML diagnosed","2026-08-03",{"date":635,"type":33},"2026-08-04",{"date":637,"type":33},"2025-05-05",{"date":639,"type":22},"2032-08-27",{"name":617,"class":341},203,""]