[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Belgium\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":668},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,1998,0,25,[9,55,91,115,139,168,199,224,252,277,309,331,359,389,413,446,497,515,530,551,572,592,613,632,648],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100630823","phase-2-a-study-of-bms-986504-monotherapy-and-in-combination-with-other-agents-in-participants-with-advanced-andor-metastatic-solid-tumors-with-homozygous-mtap-deletion-mountaintap-5-100630823",false,"NCT07492680","A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and\u002For Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)","A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and\u002For Metastatic Solid Tumors With Homozygous MTAP Deletion","Inclusion Criteria:\n\n* Participant must have histologically confirmed diagnosis of advanced and\u002For metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.\n* Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease.\n* Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline.\n* Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer must be ≤ 2 × ULN.\n* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor.\n* Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).\n* Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications.\n* Participants must not have inadequate organ function, as determined by laboratory testing within the screening period.\n* Participants must not have active viral HBV or HCV hepatitis.\n* Other protocol defined inclusion\u002Fexclusion criteria applies.","ALL","18 Years",{"count":20,"type":21},260,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and\u002For metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.",[27],"Solid Tumors",[29,30,31,32,33,34,35,36,37,38,39,40,41],"MTAP","CDKN2A","PRMT5","MountainTAP","Targeted therapy","Brain cancer","GBM","Melanoma","NSCLC","Lung cancer PDAC","Pancreatic cancer","Navlimetostat","Navli","RECRUITING","2026-08-24",{"date":45,"type":46},"2026-08-25","ACTUAL",{"date":48,"type":46},"2026-07-27",{"date":50,"type":21},"2032-05-20",{"name":52,"class":53},"Bristol-Myers Squibb","INDUSTRY",57,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":12,"sex":17,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":90},"100626898","partial-range-of-field-iols-in-dmek-enabled-procedures-100626898","NCT07441616","Partial Range Of Field IOLs in DMEK-Enabled Procedures","A Feasibility Study Evaluating Visual Outcomes of Extended Partial Range of Field Refractive Intraocular Lenses in Patients Undergoing Combined Cataract Surgery and Descemet Membrane Endothelial Keratoplasty (Triple DMEK)","PROFIDE","Inclusion Criteria:\n\n* Patients with bilateral cataract grade greater than II, according to the Lens Opacities Classification System III (LOCS III) , combined with FECD displaying clinical or subclinical corneal edema or displaying visual disturbing guttae with at least Krachmer grade 3\n* Patients aged between 40 and 90 years\n* Capacity to read and to understand the study information and to provide informed consent, as well as Patient Reported Spectacle Independence Questionnaire (PRSIQ) and Patient Reported Visual Symptom Questionnaire (PRVSQ)\n* Patients willing and capable to attend the 6-month follow-up appointment\n\nExclusion Criteria:\n\n* history of ocular surgery\n* corneal scars\n* macular disease revealed by pre-surgical macular Optical Coherence Tomography (OCT),\n* opticopathy\n* glaucoma with reduced sensitivity of visual field\n* uveitis\n* amblyopia\n* axial length \\\u003C22mm or \\>25mm,\n* scotopic pupil size \\>5mm,\n* central corneal thickness \\>700microns,\n* corneal astigmatism \\>1 diopters (D) on biometry\n* irregular astigmatism (RMS HOA 3mm pupil \\>0.3)\n* angle kappa \\>0.3mm ((chord µ measured with Pentacam HR; Oculus, Wetzlar, Germany)","40 Years","90 Years",{"count":66,"type":21},10,[68],"NA","Study Overview\n\nThis study aims to evaluate the visual outcomes, quality of vision, and patient satisfaction after receiving an extended range PRoF intraocular lens (IOL) during triple Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. This surgery is typically performed to treat patients with both corneal endothelial dysfunction and cataracts. By testing a newer IOL, the PureSee™ extended PRoF IOL, this study hopes to improve the way ophthalmologists plan surgeries and select IOLs for these patients, ultimately helping surgeons optimize the results and expand the options available for people undergoing this procedure.\n\nPurpose of the Study\n\nThe goal of this study is to evaluate how well the PureSee™ IOL works in terms of intermediate visual acuity (how well participants can see things at an arm's length). The investigators will also measure the quality of vision, satisfaction, and whether participants need glasses after surgery.\n\nThe investigators have set the following goals for this study:\n\nPrimary Goal:\n\nTo measure how well patients can see intermediate distances (uncorrected intermediate visual acuity, or UIVA) after receiving the PureSee™ IOL during triple DMEK surgery.\n\nSecondary Goals:\n\nTo understand how independent patients are from glasses after surgery.\n\nTo measure patients' uncorrected and best-corrected visual acuity (sharpness of vision) at distance, intermediate, and near vision after surgery.\n\nTo evaluate the uncorrected defocus curve (how the vision of participants changes when focusing at different distances).\n\nTo measure contrast sensitivity (how well participants can see in low-light conditions or with subtle contrasts).\n\nWho Can Join This Study?\n\nTo participate in this study, participants need to:\n\nBe undergoing triple DMEK surgery for endothelial dysfunction and cataract at the time of enrollment.\n\nBe eligible to receive an extended range of vision IOL as part of the procedure.\n\nThis study is looking for patients who are interested in understanding how new IOL technology might improve their postoperative vision quality and reduce their dependence on glasses.\n\nWhat Will Happen During the Study?\n\nParticipants will have their visual outcomes and satisfaction measured at specific times following surgery. This includes:\n\nTesting uncorrected and best-corrected visual acuity at several distances (distance, intermediate, and near).\n\nCompleting a survey about how satisfied they are with their vision and how often they need glasses or contact lenses.\n\nUndergoing testing to measure contrast sensitivity (how well participants can see in low-light conditions).\n\nWhy Is This Study Important?\n\nThe results of this study will help doctors make better decisions about which IOLs to use during triple DMEK surgery. By evaluating the PureSee™ extended PRoF IOL, the investigators hope to expand options for patients and potentially improve visual outcomes and postoperative satisfaction. Ultimately, this study could help improve the quality of life for patients who have both cataracts and endothelial dysfunction.\n\nStudy Duration\n\nParticipants can expect to undergo their last assessment 6 months post-surgery to track their progress.",[71,72],"Cataract","Fuchs Endothelial Corneal Dystrophy",[74,75,76,77,78,79,80],"dmek","triple","endothelial keratoplasty","fuchs","cataract","edof iol","partial range of field iol","NOT_YET_RECRUITING",{"date":45,"type":46},{"date":84,"type":21},"2026-10",{"date":86,"type":21},"2028-09",{"name":88,"class":89},"Universitair Ziekenhuis Brussel","OTHER",1,{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100617698","phase-3-pridopidine-phase-3-study-to-evaluate-efficacy-and-safety-in-als-100617698","NCT07322003","Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS","A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Amyotrophic Lateral Sclerosis","PREVAiLS","Key Inclusion Criteria:\n\n* Definite ALS or Probable ALS using the El Escorial criteria.\n* Symptom onset of ≤18 months at screening.\n* Slow vital capacity (SVC) greater or equal to 60% predicted.\n* Treatment Research Initiative to Cure ALS (TRICALS) Risk Profile Calculator score, based on the European Network for the Cure of ALS (ENCALS) survival prediction model, in the range of -6 to -2, inclusive, at screening.\n* Able to swallow a capsule.\n\nKey Exclusion Criteria:\n\n* Presence of tracheostomy or permanent assisted ventilation.\n* Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, or presence of left bundle branch block.\n* Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent and participate in the study.\n* Clinically significant and\u002For unstable medical condition (other than ALS) that may either pose a clinically meaningful risk to the participant and\u002For to study completion.\n* Use of medications that prolong QT interval.\n* Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides.\n* Confirmed mutation in the SOD1, FUS or C9orf72 gene.\n* Pregnancy.","80 Years",{"count":101,"type":21},500,[103],"PHASE3","The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults. It will also help to learn about the safety of pridopidine. The main question it aims to answer is:\n\nDoes pridopidine slow disease progression of ALS?\n\nResearchers will compare pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works to treat ALS.\n\nParticipants will:\n\nTake pridopidine or a placebo by mouth every day for 48 weeks. Afterwards, all participants will take pridopidine for another 48 weeks.\n\nVisit the clinic once every 1-3 months for checkups and tests",[106],"Amyotrophic Lateral Sclerosis",{"date":45,"type":46},{"date":109,"type":46},"2026-02-01",{"date":111,"type":21},"2029-03",{"name":113,"class":53},"Prilenia",56,{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":17,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":131,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100610019","phase-3-a-study-of-baricitinib-ly3009104-for-the-delay-of-stage-3-type-1-diabetes-in-at-risk-children-and-adults-100610019","NCT07222137","A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults","A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to \u003C36 Years","BARICADE-DELAY","Inclusion Criteria:\n\n* Have a history of at least one documented occasion of at least two diabetes-related autoantibodies, AND one occasion of at least two diabetes-related autoantibodies obtained at screening or prescreening\n* Have Stage 1b or Stage 2 type 1 diabetes\n* Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening\n\nExclusion Criteria:\n\n* Have any other type of diabetes\n* Have uncontrolled high blood pressure\n* Have had a heart attack, heart disease, stroke, or heart failure\n* Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy\n* Have a current or recent clinically serious infection","1 Year","35 Years",{"count":126,"type":21},150,[103],"The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.",[130],"Diabetes Mellitus, Type 1",{"date":45,"type":46},{"date":133,"type":46},"2026-01-12",{"date":135,"type":21},"2031-07",{"name":137,"class":53},"Eli Lilly and Company",113,{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":160,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":167},"100604873","phase-2-a-study-to-evaluate-the-optimal-dose-adverse-events-and-change-in-disease-activity-of-intravenous-abbv-706-in-combination-with-atezolizumab-versus-standard-of-care-as-first-line-treatment-in-adult-participants-with-previously-untreated-extensive-stage-small-cell-lung-cancer-100604873","NCT07155174","A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer","A Phase 2 Randomized, Open Label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Subjects With Previously Untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC)","SEZanne","Inclusion Criteria:\n\n* Diagnosis of histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC) requiring treatment with first line therapy.\n* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 during the screening period prior to the first dose of study treatment.\n* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n* Suspected brain metastases at screening should have a computed tomography (CT)\u002F magnetic resonance imaging (MRI) of the brain prior to study entry.\n\nExclusion Criteria:\n\n* Have received any kind of treatment for limited stage small cell lung cancer (LS-SCLC).\n* Known active\u002Fsymptomatic central nervous system (CNS) metastases should be excluded.\n* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD\u002Fpneumonitis on screening chest computed tomography (CT) scan should be excluded.\n* Have any clinically significant conditions that would adversely affect the participant's participation in the study, and the subject should have a life expectancy of at least 3 months.",{"count":148,"type":21},180,[24],"Small cell lung cancer (SCLC) is characterized by aggressive and rapid growth and a tendency to develop early spread to distant sites including mediastinal lymph nodes, liver, bones, adrenal glands, and brain. The purpose of this study is to assess safety, dose, change in disease activity of ABBV-706 given with atezolizumab, compared to standard of care (SOC) treatment (etoposide, carboplatin, atezolizumab, and optional lurbinectedin).\n\nABBV-706 is an investigational drug being developed for the treatment of SCLC. There are multiple treatment arms in this study. Participants will either receive ABBV-706 given with atezolizumab, at 1 of 2 doses, or SOC. Approximately 180 adult participants will be enrolled in the study across sites worldwide.\n\nIn the safety lead-in, participants with SCLC will receive intravenous (IV) ABBV-706 in 1 of 2 doses with IV atezolizumab, or IV SOC. In the expansion portion of the study, participants with SCLC will receive IV ABBV-706 in 1 of 2 doses with atezolizumab, or IV SOC, until the optimal dose of ABBV-706 is determined. The estimated duration of the study is up to 69.5 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.",[152],"Small Cell Lung Cancer",[152,154,155,156,157,158,159],"SCLC","ABBV-706","Etoposide","Carboplatin","Atezolizumab","Lurbinectedin",{"date":45,"type":46},{"date":162,"type":46},"2025-11-25",{"date":164,"type":21},"2031-09",{"name":166,"class":53},"AbbVie",67,{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},"100600637","phase-2-study-of-izalontamab-brengitecan-bms-986507-versus-platinum-pemetrexed-for-egfr-mutated-non-small-cell-lung-cancer-after-failure-of-egfr-tki-therapy-izabright-lung01-100600637","NCT07100080","Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)","IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2\u002F3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy","Inclusion Criteria:\n\n* Non-squamous NSCLC, not amenable to treatment in curative intent.\n* Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).\n* Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.\n* Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).\n\nExclusion criteria:\n\n* Inadequate organ function and\u002For bone marrow reserve.\n* Leptomeningeal metastases or spinal cord compression.\n* Poorly controlled systemic medical conditions.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":101,"type":21},[24,103],"A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy",[179],"Non-Small Cell Lung Cancer",[181,182,183,184,185,186,187,188,189,157,190,191],"Epidermal Growth Factor Receptor","Tyrosine Kinase Inhibitors","Osimertinib","Standard of Care","Lung Neoplasms","Antineoplastic Agents","Izalontamab brengitecan","Iza-bren","BL-B01D1","Cisplatin","Pemetrexed",{"date":45,"type":46},{"date":194,"type":46},"2025-11-05",{"date":196,"type":21},"2030-11-15",{"name":52,"class":53},186,{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":223},"100597842","a-study-to-compare-the-combination-of-navlimetostat-bms-986504-with-pembrolizumab-and-chemotherapy-versus-placebo-plus-pembrolizumab-and-chemotherapy-in-first-line-metastatic-non-small-cell-lung-cancer-participants-with-homozygous-mtap-deletion-100597842","NCT07063745","A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","A Randomized Phase 2\u002F3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","MountainTAP-29","Inclusion Criteria\n\n* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.\n* Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Participants must have at least 1 measurable lesion as per RECIST v1.1.\n\nExclusion Criteria\n\n* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.\n* Participants must not have symptomatic brain metastases or spinal cord compression.\n* Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).\n\nNote: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.\n\n* Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":208,"type":21},590,[24,103],"The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion",[212],"Metastatic Non-small Cell Lung Cancer With MTAP Deletion",[31,214,37,29,30,215,216,40],"Lung cancer","MRTX1719","First-line",{"date":45,"type":46},{"date":219,"type":46},"2026-01-02",{"date":221,"type":21},"2031-08-12",{"name":52,"class":53},320,{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":251},"100572003","phase-2-a-study-to-assess-the-efficacy-safety-and-tolerability-of-imvt-1402-as-treatment-for-adult-participants-with-graves-disease-100572003","NCT06727604","A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease","A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease","Inclusion Criteria:\n\n* Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.\n* Male or female participants aged ≥ 18 years.\n* Participants with diagnosis of GD who are hyperthyroid despite ATD treatment.\n* Other, more specific inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.\n* Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.\n* Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and\u002For are planning corrective surgery\u002Firradiation or medical therapy for TED during study participation.\n* Additional exclusion criteria are defined in the protocol.","75 Years",{"count":233,"type":21},240,[24],"This is a study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.\n\nThe primary objective of this study is to evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (total triiodothyronine \\[T3\\] or free triiodothyronine \\[FT3\\]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26.",[237],"Graves' Disease",[239,240,241,242,243],"IMVT-1402","Anti Thyroid Drug","Hyperthyroidism","Autoimmune thyroid disease","Imeroprubart",{"date":45,"type":46},{"date":246,"type":46},"2024-12-17",{"date":248,"type":21},"2028-06",{"name":250,"class":53},"Immunovant Sciences GmbH",134,{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":17,"minAge":259,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":54},"100544252","phase-3-a-study-of-pitolisant-in-patients-with-prader-willi-syndrome-100544252","NCT06366464","A Study of Pitolisant in Patients With Prader-Willi Syndrome","A Phase 3, Randomized, Double-Blind, Placebo-controlled, Efficacy and Safety Study of Pitolisant Followed by an Open-Label Extension in Patients With Prader-Willi Syndrome","Inclusion Criteria:\n\n* Genetically confirmed diagnosis of PWS\n* Excessive daytime sleepiness\n* Has a consistent parent\u002Fcaregiver (preferably the same person throughout the study) who is willing and able to complete the required study assessments.\n* In the opinion of the Investigator, the patient\u002Fparent(s)\u002Fcaregiver(s)\u002Flegal guardian(s) are capable of understanding and complying with the requirements of the protocol and administration of oral study drug.\n\nExclusion Criteria:\n\n* Has a diagnosis of sleep apnea (OSA, CSA) that is not adequately controlled\n* Has a diagnosis of hypersomnia due to another sleep\u002Fmedical disorder\n* Participation in an interventional research study involving another investigational medication, device, or behavioral treatment within 30 days or 5 half-lives (whichever is longer) of the investigational medication prior to Screening","6 Years",{"count":251,"type":21},[103],"This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome.\n\nThe primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome.\n\nSecondary objectives include assessing the impact of pitolisant on:\n\nIrritable and disruptive behaviors Hyperphagia Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity\u002Fnoncompliance, and inappropriate speech",[264],"Prader-Willi Syndrome",[266,267,268,269],"pitolisant","excessive daytime sleepiness","irritable and disruptive behaviors","Prader-Willi syndrome",{"date":45,"type":46},{"date":272,"type":46},"2024-05-28",{"date":274,"type":21},"2028-04",{"name":276,"class":53},"Harmony Biosciences Management, Inc.",{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":17,"minAge":284,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":22,"phases":287,"briefSummary":289,"conditions":290,"keywords":296,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":308},"100537335","phase-1-phase-1-safety-and-tolerability-study-of-xmab541-in-advanced-solid-tumors-100537335","NCT06276491","Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors","A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Age ≥ 18 years. For US only: subjects with GCTs, age ≥15 years\n* CLDN6+ tumor\n* Histological or cytological documentation of locally advanced, recurrent, or metastatic ovarian, fallopian tube, or peritoneal cancer, adenocarcinoma of the endometrium (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus), GCT resistant to previous treatment\n* Adequate Eastern Cooperative Oncology Group performance status\n* Life expectancy ≥ 3 months\n* Adequate liver, kidney, and bone marrow function\n\nKey Exclusion Criteria:\n\n* Participants with untreated brain metastases are excluded. Participants with treated brain metastases may participate, provided they are radiologically stable.\n* Active known or suspected autoimmune disease\n* Have any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug\n* Clinically significant cardiovascular, pulmonary or gastrointestinal disease\n* Active hepatitis B or hepatitis C","15 Years",{"count":286,"type":21},282,[288],"PHASE1","The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 on tumor outcomes.",[291,292,293,294,295],"Ovarian Cancer","Endometrial Cancer","Germ Cell Tumor","Testicular Germ Cell Tumor","Ovarian Germ Cell Tumor",[297,291,298,299,293,292,300],"Phase 1","CLDN6","Testicular Cancer","T-cell Engager",{"date":45,"type":46},{"date":303,"type":46},"2024-04-04",{"date":305,"type":21},"2028-12",{"name":307,"class":53},"Xencor, Inc.",22,{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":22,"phases":317,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":330},"100520674","bradycardia-pacemaker-with-av-interval-modulation-for-blood-pressure-treatment-100520674","NCT06059638","BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT","BACKBEAT","Inclusion Criteria:\n\n1. Patient has or is indicated for a dual-chamber pacemaker. Visit 1 can be performed within 30 days prior to a planned implant of a Medtronic Astra\u002FAzure dual-chamber pacemaker system or at any time thereafter\n2. On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug\n3. Office SBP ≥135 mmHg and \\\u003C180 mmHg\n4. Average 24-Hour aSBP ≥130 mmHg and \\\u003C170 mmHg\n\nExclusion Criteria:\n\n1. LVEF \\\u003C50%\n2. NYHA Class III-IV\n3. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months\n4. Myocardial infarction (MI) within 3 months\n5. Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months\n6. Permanent atrial fibrillation\n7. Mitral valve regurgitation greater than or equal to grade 3\n8. Aortic stenosis with a valve area less than 1.5 cm2\n9. Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)\n10. Has an existing active cardiac device or neurostimulator other than the recent Astra\u002FAzure pacemaker implant",{"count":101,"type":21},[68],"A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra\u002FAzure pacemaker.",[320,321,322],"Hypertension","Hypertension, Systolic","Hypertension, Essential",{"date":45,"type":46},{"date":325,"type":46},"2023-12-27",{"date":327,"type":21},"2029-08",{"name":329,"class":53},"Orchestra BioMed, Inc",130,{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":345,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":358},"100409600","phase-2-phase-2-trial-of-adagrasib-monotherapy-and-in-combination-with-pembrolizumab-and-a-phase-3-trial-of-adagrasib-in-combination-in-patients-with-a-kras-g12c-mutation-krystal-7-100409600","NCT04613596","Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7","A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","Inclusion Criteria:\n\n* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS\n* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\\>=50%\n* Phase 3: Presence of measurable disease per RECIST1.1\n* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:\n\n  1. No evidence of brain metastases\n  2. Untreated brain metastases not needing immediate local therapy\n  3. Previously treated brain metastases not needing immediate local therapy\n\nExclusion Criteria:\n\n* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).\n* Phase 2: Active brain metastases\n* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:\n\n  1. Any untreated brain lesions \\> 2.0 cm in size\n  2. Any brainstem lesions\n  3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \\> 10 mg of prednisone (or equivalent) prior to randomization.\n  4. Have poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy\n* Phase 3: Radiation to the lung \\> 30 Gy within 6 months prior to the first dose of study treatment",{"count":339,"type":21},626,[24,103],"The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.\n\nThe Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \\>=50% and who are candidates for first line treatment.",[343,344],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[346,347,37,344,348,349,350],"KRAS G12C","Non-small cell lung cancer","Adagrasib","Krazati","TPS",{"date":45,"type":46},{"date":353,"type":46},"2020-12-02",{"date":355,"type":21},"2029-10-31",{"name":357,"class":53},"Mirati Therapeutics Inc.",770,{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":17,"minAge":366,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":22,"phases":369,"briefSummary":370,"conditions":371,"keywords":376,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":90},"100653354","improvement-through-movement---balance-control-and-somatosensory-function-in-people-with-diabetes-mellitus-type-2-100653354","NCT07786194","Improvement Through Movement - Balance Control and Somatosensory Function in People With Diabetes Mellitus Type 2","Improvement Through Movement - Balance Control and Somatosensory Function in People With Diabetes Mellitus Type 2: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes mellitus\n* Age 60 years or older\n* Both men and women\n* Impaired balance control identified during the testing procedure for balance control, defined as a score of less than 30 seconds on the Standing on Foam with Eyes Closed test and\u002For less than 10 seconds on the Single Leg Stance with Eyes Open test\n* Able to understand the Dutch language.\n\nExclusion Criteria:\n\n* A history of central neurological disease including stroke, multiple sclerosis, Parkinson's disease, dementia or intracranial tumor\n* Severe visual impairment such as blindness, cataract or glaucoma\n* Physical impairment which would preclude subjects from participating in an exercise \u002Fphysical activity program (e.g. orthopedic conditions, severe cardiac conditions, uncontrolled hypertension etc.)\n* Need of physical or material support\n* HbA1c \\\u003C 7.5% (- the aim is to include patients with an HbA1c of \\\u003C7.5%, but if the treating endocrinologist considers an HbA1c value of 7.5 - 8% desirable for medical reasons, this patient will still be included)\n* Use of medication that can affect balance (e.g. sedatives, antidepressants, or antipsychotics)\n* Not understanding the Dutch language","60 Years",{"count":368,"type":21},48,[68],"This study focuses on improving balance control and somatosensory functions in individuals aged 60 years and older with diabetes mellitus tyoe 2 (DMT2). Older adults with DMT2 are at an increased risk of balance problems due to diabetic complications such as neuropathy, retinopathy, and possibly reduced vestibular function. The aim of the study is to investigate whether a 12-week exercise program, with or without additional balance exercises, can improve balance control, enhance somatosensory functions (such as touch and vibration thresholds), and positively impact diabetes-related parameters, including HbA1c levels.\n\nThe study is designed as a randomized controlled trial (RCT). Participants are selected based on reduced balance control identified in a prior cross-sectional study. The intervention group follows an exercise program in accordance with international guidelines, supplemented with balance exercises supervised by the researcher (physiotherapist). The control group follows the same guidelines but without balance exercises; instead, they perform relaxation exercises. Balance control is assessed both statically and dynamically, while somatosensory functions are measured, and diabetes-related parameters are collected.\n\nThe intervention is primarily home-based, supported by an activity tracker, but the balance or relaxation exercises are conducted under supervision at a designated location. This study aims to contribute to the quality of life of older adults with DMT2 by reducing balance problems and fall risks.",[372,373,374,375],"Diabetes Mellitus Type 2","Impaired Balance in Elderly","Somatosensory Disorders","Balance Control in Elderly",[377,378,379,380],"Improvement of balance control in elderly with diabetes mellitus type 2 through exercise","balance training","exercise","movement","2026-08-21",{"date":45,"type":46},{"date":384,"type":46},"2025-11-13",{"date":386,"type":21},"2027-08-31",{"name":388,"class":89},"Universiteit Antwerpen",{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":397,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":400,"phases":4,"briefSummary":401,"conditions":402,"keywords":404,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":90},"100653265","new-consciousness-indicators-nci-100653265","NCT07786298","New Consciousness Indicators (NCI)","Validation of New Consciousness Indicators in Conscious Participants","NCI","Inclusion Criteria:\n\n* Adult, French-speaking individuals with no neurological and\u002For psychiatric disorders or history thereof, and no uncorrected sensorimotor deficits.\n\nExclusion Criteria:\n\n* Minors, non-French-speaking individuals, individuals with neurological and\u002For psychiatric disorders or a history thereof, and individuals with uncorrected sensorimotor deficits.",true,{"count":399,"type":21},100,"OBSERVATIONAL","The assessment of the diagnosis and prognosis of patients with disorders of consciousness (DoC) represents a major clinical and ethical challenge, as it may influence therapeutic decision-making. Despite the use of standardized assessment tools such as the Coma Recovery Scale-Revised (CRS-R), diagnostic errors persist. In order to improve the identification of residual conscious activity, several research studies have focused on identifying and validating new clinical indicators of consciousness.\n\nIn addition to the items already included in the CRS-R to characterize a minimally conscious state, some behavioral manifestations that are not yet included in current assessment scales are being investigated for their diagnostic potential. Mat et al. (2022) proposed several behavioral indicators, including leg crossing, auditory localization, habituation to the auditory startle reflex, resistance to eye opening, spontaneous blink rate, certain motor behaviors, facial expressions in response to nociceptive stimulation, swallowing or oral intake, and responses to olfactory stimuli. To these indicators, we added other potentially relevant behavioral manifestations, including responses to tickling, anticipation of painful stimulation, and responses to pleasant touch.\n\nThese different items were grouped into an Additional Signs of Consciousness (ASC) Scale. This scale aims to investigate whether these behavioral manifestations may constitute reliable new indicators of consciousness and contribute to improving the diagnostic and prognostic assessment of patients with DoC.\n\nTo date, this scale has primarily been used in post-coma patients with DoC. However, it is essential to assess the validity of these indicators in healthy, fully conscious participants. Indeed, the relevance of these signs as indicators of residual consciousness in post-coma patients can only be properly interpreted if they are also observable in conscious individuals. Therefore, the aim of this study is to validate these new indicators of consciousness in conscious participants.",[403],"Consciousness Assessment",[405],"Consciousness Assessment, Consciousness Indicators, Additional Signs of Consciousness (ASC)",{"date":45,"type":46},{"date":408,"type":21},"2026-09",{"date":410,"type":21},"2027-06",{"name":412,"class":89},"University of Liege",{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":419,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":421,"minAge":18,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":22,"phases":424,"briefSummary":425,"conditions":426,"keywords":430,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":438,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":445},"100653021","phase-3-best-salvage-treatment-for-high-risk-relapsing-prostate-cancer-peace-9---escalate-rt-100653021","NCT07782112","Best Salvage Treatment for High-risk Relapsing Prostate Cancer (PEACE-9 - ESCALATE-RT)","PEACE-9 - ESCALATE-RT: A Phase III Randomized Study in Patients With High-risk PSA Relapse After Local Therapy Treated With Enzalutamide Plus Androgen Deprivation Therapy and Comparing MDT ± Pelvic Radiotherapy Versus no Further Treatment","ESCALATE-RT","Inclusion Criteria:\n\n* Histologically proven initial diagnosis of adenocarcinoma of the prostate\n* Rising PSA after local therapy as defined by PSA ≥ 0.2 ng\u002FmL after RP +\u002F- adjuvant\u002Fsalvage prostate bed RT and at least 2 ng\u002FmL above nadir for primary RT, with a PSADT ≤ 9 months\n* Serum Testosterone ≥ 150 ng\u002Fdl (6.9343 nM\u002FL)\n* On PSMA PET\u002FCT restaging presence of: 1 to 5 distant metastases that are amenable to MDT ± N1 patients (no limit in the number of nodes)\n* ECOG performance status 0 - 2\n* Age \\> or =18 years\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial\n* Before patient registration\u002Frandomization, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations\n\nExclusion Criteria:\n\n* More than 5 distant PSMA positive metastases and\u002For brain or leptomeningeal metastases.\n* Prostate recurrence (positive PSMA disease) after primary prostate irradiation\n* Prostate bed recurrence (positive PSMA disease) after salvage\u002Fadjuvant irradiation\n* Pelvic nodal recurrence (positive PSMA disease) after primary WPRT irradiation\n* Contraindications to pelvic RT and\u002For MDT\n* Prior evidence of distant metastatic disease\n* Contraindications to ADT\n* Contraindication for treatment with enzalutamide\n* Prior hormonal therapy (Neoadjuvant\u002Fadjuvant therapy to treat PCa ≤ 36 months in duration and ≥ 9 months before randomization is allowed)\n* Previous treatment with cytotoxic agent for PCa\n* Any active malignancies (i.e., progressing or requiring any treatment in the previous 36 months) other than prostate cancer (except non-muscle invasive bladder cancer; non-melanomatous skin cancer or a malignancy that is considered cured with minimal risk of recurrence","MALE",{"count":423,"type":21},140,[103],"The goal of this clinical trial is to learn if adding metastasis-directed radiotherapy with or without pelvic salvage radiotherapy, to intermittent prostate cancer drugs (intensified hormone therapy) can delay the need to restart these drugs in men with oligometastactic prostate cancer recurrence.\n\nIn practice, this study is open to men whose PSA level (a blood marker of cancer activity) is rising as defined by biochemical recurrence, and who have 1 to 5 areas of cancer spread (1 to 5 metastases defining oligometastatic status) found on a specialized scan (PSMA PET\u002FCT).\n\nSince intensified hormone therapy, including androgen deprivation therapy combined with a next-generation hormone therapy, represents the standard treatment strategy for these patients, researchers want to find out if adding radiation therapy can help patients to spend more time off cancer drugs while keeping their cancer under control.\n\nThe main questions this trial aims to answer are:\n\n* Does adding radiation therapy to each metastases with or without pelvic area, lengthen the time before participants need to restart drug treatment?\n* Does adding radiation therapy increase the number of participants whose PSA drops to a very low level (0.2 ng\u002FmL or lower)?\n* Does adding radiation therapy affect participants' quality of life?\n\nResearchers will randomly assign participants (chosen by chance) to receive either enzalutamide (next-generation hormone therapy) plus androgen-deprivation therapy (first-generation hormone therapy ) alone, or the same association of these drugs combined with radiation therapy aimed at each metastases with or without pelvic area.\n\nThis comparison will show whether adding radiation therapy helps participants reach a deeper PSA response and go longer without needing cancer drugs.\n\nParticipants will:\n\n* Take enzalutamide and androgen-deprivation therapy for 9 months\n* Have an equal chance of also receiving radiation therapy to each metastases with or without pelvic area\n* Stop drug treatment after 9 months if their PSA drops below 0.2 ng\u002FmL, a level showing the cancer is well controlled\n* Restart drug treatment if their PSA rises again during the treatment-free period\n* Have regular blood tests and clinic visits to check their PSA, testosterone, and overall health\n* Complete short quality-of-life questionnaires during the study\n* Take part in a study conducted at several hospitals in Switzerland, Belgium, and France.",[427,428,429],"Prostatic Neoplasms","Biochemical Recurrence","Oligometastatic Prostate Cancer",[431,432,433,434,435,436,437],"High-risk PSA relapse","Oligometastatic recurrence","Salvage treatment","Metastasis-directed therapy","Pelvic radiotherapy","Androgen Deprivation Therapy","Enzalutamide",{"date":43,"type":46},{"date":440,"type":21},"2026-11",{"date":442,"type":21},"2030-07",{"name":444,"class":89},"Ente Ospedaliero Cantonale, Bellinzona",19,{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":452,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":421,"minAge":454,"maxAge":455,"enrollmentInfo":456,"targetDuration":4,"studyType":22,"phases":458,"briefSummary":459,"conditions":460,"keywords":475,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":490,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":494,"locationsCount":496},"100638788","phase-3-a-phase-3-study-to-evaluate-the-safety-and-efficacy-of-aoc-1044-also-referred-to-as-delpacibart-zotadirsen-in-participants-with-dmd-with-gene-mutations-amenable-to-exon-44-skipping-100638788","NCT07587242","A Phase 3 Study to Evaluate the Safety and Efficacy of AOC 1044 (Also Referred to as Delpacibart Zotadirsen) in Participants With DMD With Gene Mutations Amenable to Exon 44 Skipping","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Global Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Intravenous AOC 1044 (Delpacibart Zotadirsen) for the Treatment of DMD With Gene Mutations Amenable to Exon 44 Skipping","SAFARI44","Key Inclusion Criteria:\n\n* Ambulatory males with clinical and genetic diagnosis of DMD\n* Acceptable genetic test confirming dystrophin gene mutation amenable to exon 44 skipping\n* 7 to 16 years of age at time of consent\n* TTR and NSAA assessment completed within the protocol specified parameters at Screening\n* On a stable regimen of corticosteroids (including Vamolorone) for at least 6 months prior to Day 1. Steroid regimen must be anticipated to remain stable.\n\nKey Exclusion Criteria:\n\n* Previous treatment cell or gene therapy.\n* Treatment with another oligonucleotide within 6 months of informed consent (not including COVID-19 RNA vaccines).\n* Lab values outside of the protocol specified range at Screening\n* If on any of the following treatments (growth hormone, testosterone or givinostat), participants must be on a stable regimen and must plan to maintain it for the duration of the study. Participants will be excluded if regimen stability prior to informed consent is as follows:\n* Less than 1 month, for growth hormone and\u002For testosterone\n* Less than 6 months for givinostat","7 Years","16 Years",{"count":457,"type":21},70,[103],"A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1044 for the treatment of Duchenne Muscular Dystrophy (DMD) with Gene Mutations Amenable to Exon 44 Skipping",[461,462,463,464,465,466,467,468,469,470,471,472,473,474],"Muscular Dystrophies","Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy)","Muscular Disorders, Atrophic","Muscular Disease","Musculoskeletal Diseases","Neuromuscular Diseases (NMD)","Nervous System Diseases","Genetic Diseases","X-Linked","Hereditary","Neonatal Disease","Duchene Muscular Dystrophy","Congenital","DMD",[476,477,478,479,480,481,482,483,452,484,485,486,487,488,489,474],"AOC","AOC 1044","AOC 1044-CS3","AOC 1044-CS1","AOC 1044-CS2","EXPLORE44","EXPLORE44-OLE","SAFARI","SAFARI 44","Avidity","Avidity Biosciences","Exon Skipping Therapy","Avidity Biosciences Inc., A Novartis Company","del-zota",{"date":43,"type":46},{"date":492,"type":21},"2026-08",{"date":442,"type":21},{"name":495,"class":53},"Avidity Biosciences, Inc.",12,{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":99,"enrollmentInfo":504,"targetDuration":4,"studyType":22,"phases":506,"briefSummary":507,"conditions":508,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":66},"100636862","phase-1-a-master-protocol-olmp-a-study-of-ly4256984-in-participants-with-amyotrophic-lateral-sclerosis-als-100636862","NCT07571200","A Master Protocol (OLMP): A Study of LY4256984 in Participants With Amyotrophic Lateral Sclerosis (ALS)","A Master Protocol for Open-Label Extension Studies to Evaluate the Long-Term Safety and Tolerability of Interventions in Various Stages of Clinical Development in Participants With Amyotrophic Lateral Sclerosis","Participants must meet eligibility criteria below. Additional criteria are specified in the substudy to which the participant will enroll.\n\nInclusion Criteria:\n\n* Have completed an eligible parent study, as determined by the investigator. Eligible parent studies will be defined by the sponsor but will be clinical studies designed to evaluate a study intervention for the treatment of ALS.\n\n  * Note 1: To be considered a \"completer\" of a parent study, the participant must finish the main treatment period\u002Fphase of the parent study as well as any off-treatment period\u002Fphase as described in the parent study's protocol.\n  * Note 2: Visits missed in a parent study will have no impact on the completer status of a potential participant.\n\nExclusion Criteria:\n\n* During the parent study, the participant permanently or temporarily discontinued the investigational medicinal product (IMP), such that restarting the IMP would pose an unacceptable risk to the participant's safety, in the opinion of the investigator.\n* During the parent study, the participant experienced extreme ALS disease progression (for example, permanent mechanical ventilation) that poses an unacceptable risk to the participant's safety in the opinion of the investigator.\n* During the parent study, the participant developed an unresolved SAE or a medical illness (other than ALS) that, in the opinion of the investigator, precludes either continued exposure to an IMP or participation in study procedures due to an unacceptable risk to the participant's safety.",{"count":505,"type":21},32,[288],"Study OLMP is a master protocol that will support a collection of individual sub studies that share key design components. Participants from the originator study OWAA (NCT07100119) will be assigned to the appropriate study treatment group: Sporadic Amyotrophic Lateral Sclerosis OL01 (NCT07571174). The studies aim to evaluate the safety and tolerability of different treatments in participants with Amyotrophic Lateral Sclerosis (ALS) that will last at least 96 weeks.",[106],{"date":43,"type":46},{"date":511,"type":46},"2026-05-14",{"date":513,"type":21},"2029-06",{"name":137,"class":53},{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":99,"enrollmentInfo":522,"targetDuration":4,"studyType":22,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":528,"leadSponsor":529,"locationsCount":66},"100636860","phase-1-a-substudy-of-ly4256984-in-participants-with-sporadic-amyotrophic-lateral-sclerosis-100636860","NCT07571174","A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis","A Study of Long-Term Safety, Tolerability, and Clinical Outcomes of Intrathecally Administered LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis: A Multicenter, Open-Label, Long-Term Extension of Study J6I-MC-OWAA","Participants must meet eligibility criteria in the \\[L0U-MC-OLMP\\] screening protocol before entry into the treatment study.\n\nInclusion Criteria:\n\n* Have completed the main treatment period\u002Fphase as well as any off-treatment period\u002Fphase of Study OWAA, the parent study for this ISA.\n\nExclusion Criteria:\n\n* The participant has conditions that preclude a lumbar puncture (LP), such as:\n\n  * A history of clinically significant back pain, back pathology, and\u002For back injury (for example, degenerative disease, spinal deformity, or spinal surgery) that may predispose to complications or technical difficulty with LP.\n  * Allergy to local anesthetics, such as lidocaine or its derivatives.\n  * A local infection at the intended site of the LP.\n  * Less than 100 giga per liter \\[(\\\u003C100 GI\u002FL) is equivalent to 100,000 per cubic millimeter (100,000\u002Fmm³)\\] platelets or clinically significant coagulation abnormality or significant active bleeding, or\n  * Currently receiving treatment with an anticoagulant, antiplatelet agent, or other drug that affects coagulation or platelet function. Low dose (according to local medical guidelines) aspirin is permitted.",{"count":505,"type":21},[288],"The main purpose of this study is to assess the long-term safety and tolerability of LY4256984 in participants with Amyotrophic Lateral Sclerosis (ALS). This study is a long-term extension of study J6I-MC-OWAA (NCT07100119) and is part of the OLMP (NCT07571200) master protocol that will last approximately 96 weeks.",[106],{"date":43,"type":46},{"date":511,"type":46},{"date":513,"type":21},{"name":137,"class":53},{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":231,"enrollmentInfo":538,"targetDuration":4,"studyType":22,"phases":540,"briefSummary":541,"conditions":542,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":457},"100634906","phase-2-a-study-of-brenipatide-ly3537031-in-participants-with-irritable-bowel-syndrome-constipation-ibs-c-100634906","NCT07545772","A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants With IBS-C","RENEW-IBS-C","Inclusion Criteria:\n\n* Meets Rome IV criteria for irritable bowel syndrome-constipation (IBS-C) including having more than 25% bowel movements with Bristol Stool Form Scale (BSFS) Types 1 or 2 and less than 25% of bowel movements with BSFS Types 6 or 7\n* Based on the daily eDiary collection during the screening period:\n\n  * Have average of worst abdominal pain score of ≥3.0 on a 0-to-10-point scale during the 14 consecutive days prior to randomization\n\nExclusion Criteria:\n\n* Have a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea, mixed IBS, or unclassified IBS by the Rome IV criteria\n* Have a history of inflammatory or immune-mediated gastrointestinal disorders\n* Have a known clinically significant gastric emptying abnormality",{"count":539,"type":21},342,[24],"The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Constipation (IBS-C). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo.\n\nThe study will last approximately 35 weeks.",[543,544],"Irritable Bowel Syndrome","Constipation",{"date":43,"type":46},{"date":547,"type":46},"2026-04-29",{"date":549,"type":21},"2027-09",{"name":137,"class":53},{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":231,"enrollmentInfo":559,"targetDuration":4,"studyType":22,"phases":561,"briefSummary":562,"conditions":563,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":565,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":571},"100634905","phase-2-a-study-of-brenipatide-ly3537031-in-participants-with-irritable-bowel-syndrome-diarrhea-ibs-d-100634905","NCT07545759","A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants With IBS-D","RENEW-IBS-D","Inclusion Criteria:\n\n* Meet Rome IV criteria for IBS-D, which includes having greater than 25% of bowel movements with Bristol Stool Form Scale (BSFS) Types 6 or 7 and \\\u003C25% of bowel movements with BSFS Types 1 or 2\n* Based on the daily eDiary collection during the screening period:\n\n  * Have average of worst abdominal pain score of ≥3.0 on a 0-to-10-point scale during the 14 consecutive days prior to randomization\n  * Have at least 4 days per week with a maximum BSFS ≥5 AND with at least 2 days of the 4 days per week with a maximum BSFS ≥6 during the 14 consecutive days prior to randomization\n* Have had no major changes in diet in the 4 weeks prior to screening\n\nExclusion Criteria:\n\n* Have a diagnosis of IBS with a subtype of constipation, mixed IBS, or unclassified IBS by the Rome IV criteria\n* Have a history of inflammatory or immune-mediated gastrointestinal disorders\n* Have a known clinically significant gastric emptying abnormality",{"count":560,"type":21},531,[24],"The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo.\n\nThe study will last approximately 35 weeks.",[543,564],"Diarrhea",{"date":43,"type":46},{"date":567,"type":46},"2026-05-06",{"date":569,"type":21},"2027-11",{"name":137,"class":53},89,{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":231,"enrollmentInfo":579,"targetDuration":4,"studyType":22,"phases":581,"briefSummary":582,"conditions":583,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":586,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":590,"locationsCount":591},"100633925","phase-2-a-study-of-ly4005130-in-adult-participants-with-non-segmental-vitiligo-100633925","NCT07533019","A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo","A Phase 2, Randomized, 24-Week, Multicenter, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants With Non-Segmental Vitiligo","Inclusion Criteria:\n\n* Eligible participants must have the following at both screening and baseline:\n\n  * A clinical diagnosis of non-segmented vitiligo (NSV) for at least 3 months\n  * Body surface area (BSA) involvement of 4% to 60%, inclusive, excluding involvement at palms of the hands, soles of the feet, or dorsal aspect of the feet\n  * BSA involvement of ≥0.5% on the face\n  * F-VASI ≥0.5 and T-VASI ≥3, and\n  * Either active or stable disease at both screening and baseline\n\nExclusion Criteria:\n\n* Participants who have other types of vitiligo that are not considered active or stable vitiligo\n* Currently have active forms of other disorders of pigmentation\n* Currently have active forms of inflammatory skin disease(s) or evidence of skin conditions that would interfere with evaluation of vitiligo or response to treatment\n* Have a superficial skin infection within 2 weeks before baseline. Participants may be rescreened after the infection is resolved\n* Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 1 year prior to screening\n* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and\u002For unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking the study intervention or interfere with the interpretation of data\n* Any previous JAK inhibitor therapy, systemic or topical (for example, ruxolitinib, tofacitinib, baricitinib, upadacitinib, filgotinib, lestaurtinib, pacritinib) will NOT be allowed. Participant MUST be JAK inhibitor therapy-naïve",{"count":580,"type":21},66,[24],"The purpose of this study is to evaluate how well LY4005130 is tolerated and what side effects may occur in participants with non-segmental vitiligo (NSV) when compared with placebo. The study drug will be administered intravenously (IV) (into a vein in the arm).\n\nBlood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.\n\nThe study will last approximately 48 weeks, including screening.",[584,585],"Vitiligo","Non-Segmental Vitiligo (NSV)",{"date":43,"type":46},{"date":588,"type":46},"2026-04-14",{"date":549,"type":21},{"name":137,"class":53},35,{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":397,"sex":17,"minAge":18,"maxAge":599,"enrollmentInfo":600,"targetDuration":4,"studyType":22,"phases":602,"briefSummary":603,"conditions":604,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":90},"100633394","phase-1-a-first-in-human-study-to-assess-safety-tolerability-and-pharmacokinetics-of-a-single-dose-of-regn22044-in-healthy-adults-100633394","NCT07526116","A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a Single Dose of REGN22044 in Healthy Adults","A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN22044 in Healthy Adult Participants","Key Inclusion Criteria:\n\n1\\. Is judged by the investigator to be in good health as described in the protocol\n\nKey Exclusion Criteria:\n\n1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator\n2. Use of any prescription or non-prescription medications or nutritional supplements from approximately 14 days or 5 half-lives, whichever is longer, prior to administration of study intervention or any planned use through the end of the study, except the permitted medications as listed in the protocol\n3. Participants with fever (\\>38°C) associated with infection, or chronic, persistent, or recurring infection(s) requiring active treatment with antibiotics, antivirals or antifungals within 8 weeks prior to the screening visit or the randomization visit, or other frequent recurrent infections deemed unacceptable as per investigator judgment\n4. Evidence of active or latent tuberculosis (TB) as documented by medical history and examination\n\nNote: Other protocol defined Inclusion\u002F Exclusion criteria apply.","65 Years",{"count":601,"type":21},88,[288],"This clinical study will evaluate the study drug, REGN22044, in healthy participants. REGN22044 has not previously been studied in humans.\n\nThe purpose of this study is to learn:\n\n* What side effects may happen when REGN22044 is taken\n* How much of REGN22044 is in the blood at different times\n* Whether the body makes antibodies against REGN22044 (which could make the drug less effective or could lead to side effects)",[605],"Healthy Volunteer",{"date":45,"type":46},{"date":608,"type":46},"2026-06-05",{"date":610,"type":21},"2027-02-08",{"name":612,"class":53},"Regeneron Pharmaceuticals",{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":4,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":99,"enrollmentInfo":620,"targetDuration":4,"studyType":22,"phases":622,"briefSummary":623,"conditions":624,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":626,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":457},"100630086","phase-2-a-study-of-ly4395089-and-mirikizumab-ly3074828-given-together-and-mirikizumab-alone-in-adults-with-crohns-disease-100630086","NCT07483099","A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease","A Phase 2, Multicenter, Randomized, Open-Label, Active-Controlled Study to Investigate LY4395089\u002FMirikizumab Co-administration Compared With Mirikizumab in Adults With Moderately to Severely Active Crohn's Disease","Inclusion Criteria:\n\nParticipants must meet all the inclusion criteria in the IIBD master protocol, except the UC-specific criteria. In addition, they must meet the criteria below:\n\n* Participants taking glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), GLP-1\u002Fglucose-dependent insulinotropic polypeptide (GIP) RAs, GLP-1\u002Fglucagon (Gcg) RAs, GLP-1\u002FGIP\u002FGcg RAs, or similar medications for approved indications will be permitted to enroll provided they are on a stable dose at the time of screening\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the exclusion criteria in the IIBD master protocol, except the UC-specific criteria apply, or if any of the following criteria apply:\n\n* Must not have a hepatic disease\n* Must not have a history of any other bone disease that affects bone metabolism\n* Must not have had any of the following within the past 180 days before screening:\n\n  * acute myocardial infarction\n  * cerebrovascular incident\n  * hospitalization for unstable angina\n  * hospitalization due to congestive heart failure, or\n  * coronary revascularization\n* Must not have received or will need any other prohibited medications as specified in the protocol",{"count":621,"type":21},60,[24],"The main purpose of this study is to see how the safety and efficacy of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely active Crohn's disease (CD). This study is part of the IIBD master protocol and will last approximately 62 weeks.",[625],"Crohn Disease",{"date":43,"type":46},{"date":628,"type":46},"2026-05-04",{"date":630,"type":21},"2028-03",{"name":137,"class":53},{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":4,"eligibilityCriteria":638,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":99,"enrollmentInfo":639,"targetDuration":4,"studyType":22,"phases":640,"briefSummary":641,"conditions":642,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":644,"startDateStruct":645,"completionDateStruct":646,"leadSponsor":647,"locationsCount":457},"100630084","phase-2-a-master-protocol-iibd-a-study-of-multiple-drugs-in-adults-with-ulcerative-colitis-or-crohns-disease-100630084","NCT07483073","A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease","A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Interventions for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease","Inclusion Criteria:\n\n* Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports a diagnosis of UC or CD.\n* For UC:\n\n  * Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to (≥) 2, confirmed by the central reader and rectal bleeding (RB)≥1, with endoscopy performed within 21 days prior to Visit 2.\n* For CD:\n\n  * Have moderately to severely active CD as defined by a Crohn's disease activity index (CDAI) score ≥ 220 and less than or equal to (≤) 450. Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease within 21 days before the randomization\n* Must have demonstrated an inadequate response, loss of response, or intolerance to at least one of the following: corticosteroids, immunomodulators, or an advanced therapy for UC or CD\n* Have screening laboratory test results within the protocol specified parameters.\n\nExclusion Criteria:\n\n* Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis\n\n  * For UC - must not have a current diagnosis of CD\n  * For CD - must not have a current diagnosis of UC\n* Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol\n* Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndrome\n* Must not have a significant uncontrolled illness that in the opinion of the investigator may compromise the participant's safety or interfere with interpretation of data\n* Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of action\n* Must not have failed an anti-interleukin-23p19 (anti-IL-23p19) antibody treatment\n* Must not have received or will need any prohibited medications for UC or CD as specified in the protocol",{"count":621,"type":21},[24],"Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.",[643,625],"Colitis, Ulcerative",{"date":43,"type":46},{"date":628,"type":46},{"date":630,"type":21},{"name":137,"class":53},{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":4,"eligibilityCriteria":654,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":599,"enrollmentInfo":655,"targetDuration":4,"studyType":22,"phases":657,"briefSummary":658,"conditions":659,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":661,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":667},"100624674","phase-1-a-study-of-bms-986528-in-participants-with-refractory-rheumatoid-arthritis-100624674","NCT07412704","A Study of BMS-986528 in Participants With Refractory Rheumatoid Arthritis","A Phase 1\u002F2a, Open-label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of BMS-986528 in Participants With Refractory Rheumatoid Arthritis","Inclusion Criteria\n\n\\- Adult participants with rheumatoid arthritis (RA) who meet definition of difficult-to-treat.\n\nExclusion Criteria\n\n* Juvenile arthritis or onset of inflammatory arthritis before age 18.\n* Seronegative RA participants in whom polymyalgia rheumatica has not been ruled out.\n* Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":656,"type":21},84,[288,24],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the preliminary evidence of disease-modifying effect of BMS-986528 in participants with refractory, difficult-to-treat rheumatoid arthritis (RA).",[660],"Arthritis, Rheumatoid",{"date":43,"type":46},{"date":663,"type":21},"2026-09-15",{"date":665,"type":21},"2030-09-02",{"name":52,"class":53},39,""]