[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Latvia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":678},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,75,0,25,[9,49,78,105,132,157,178,207,228,249,285,309,330,352,380,405,427,455,478,503,532,559,584,615,649],{"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":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100594352","phase-2-a-study-to-assess-the-efficacy-safety-and-tolerability-of-imvt-1402-as-treatment-for-adult-participants-with-graves-disease-100594352",false,"NCT07018323","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.","ALL","18 Years","75 Years",{"count":21,"type":22},210,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b 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.",[28],"Graves' Disease",[30,31,32,33,34,35],"IMVT-1402","Graves' disease","Thyroid-Stimulating Hormone Receptor","Immunoglobulin G","Antithyroid drug","Imeroprubart","RECRUITING","2026-08-24",{"date":39,"type":40},"2026-08-25","ACTUAL",{"date":42,"type":40},"2025-06-19",{"date":44,"type":22},"2027-05",{"name":46,"class":47},"Immunovant Sciences GmbH","INDUSTRY",163,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"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":58,"type":22},119,[60],"PHASE3","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.",[63],"Acromegaly",[65,66,67,68],"IGF-1","Growth hormone","Pituitary gland","Gigantism","2026-08-21",{"date":37,"type":40},{"date":72,"type":40},"2025-11-26",{"date":74,"type":22},"2029-03",{"name":76,"class":47},"Debiopharm International SA",73,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"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":86,"type":22},3500,[60],"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.",[90,91],"Solid Tumors","Hematologic Malignancies",[93,94,95,96],"PD1","PD-1","PDL1","PD-L1",{"date":39,"type":40},{"date":99,"type":40},"2018-08-21",{"date":101,"type":22},"2043-08-04",{"name":103,"class":47},"Merck Sharp & Dohme LLC",782,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"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","50 Years",{"count":115,"type":22},960,[25,60],"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.",[119,120,121,122],"Macular Degeneration","Age-Related Macular Degeneration","Choroidal Neovascularization","Wet Macular Degeneration","2026-08-20",{"date":37,"type":40},{"date":126,"type":40},"2026-03-27",{"date":128,"type":22},"2028-06-30",{"name":130,"class":47},"EyeBiotech Ltd.",110,{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"100624854","phase-2-ly4268989-in-adults-with-moderately-to-severely-active-ulcerative-colitis-100624854","NCT07415044","LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis","A Randomized, Multicenter, Double-Blind, Placebo-Controlled Development Program to Evaluate the Efficacy and Safety of LY4268989 (MORF-057) for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-3)","EMERALD-3","Inclusion Criteria:\n\n* Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC\n* Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by central reader and rectal bleeding (RB)≥1\n* Have evidence of UC extending proximal to the rectum\n* Have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization, if the participant has a history of UC symptoms for more than 8 years\n* Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators). Participants with inadequate response to vedolizumab are excluded\n* Must meet contraception requirements\n\nExclusion Criteria:\n\n* Have a current diagnosis of\n\n  * Crohn's disease\n  * Inflammatory Bowel Disease (IBD unclassified) (formerly known as indeterminate colitis), or\n  * primary sclerosing cholangitis\n* Have an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation\n* Have had or will need bowel resection or intestinal or intra-abdominal surgery\n* Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic\n* Have any prior or current evidence of cancer gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancies\n* Have a diagnosis or history of malignant disease within 5 years prior to randomization","80 Years",{"count":142,"type":22},1431,[25],"The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally.\n\nThe study will last up to approximately 108 weeks, excluding screening.",[146,147,148],"Ulcerative Colitis (UC)","Ulcerative Colitis, Active Moderate","Ulcerative Colitis, Active Severe",{"date":69,"type":40},{"date":151,"type":40},"2026-03-26",{"date":153,"type":22},"2031-07",{"name":155,"class":47},"Eli Lilly and Company",259,{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":17,"minAge":164,"maxAge":140,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},"100549191","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-tulisokibart-mk-7240-in-participants-with-moderate-to-severe-crohns-disease-mk-7240-008-100549191","NCT06430801","A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.\n* Has moderately to severely active CD.\n* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and\u002For small molecule advanced therapies.\n* Adolescent participants ≥16 and \\\u003C18 years of age can participate if approved by the country or regulatory\u002Fhealth authority.\n\nExclusion Criteria:\n\n* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.\n* Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and\u002For ileal involvement.\n* Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.\n* Has current stoma or need for colostomy or ileostomy.\n* Is missing \\>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.\n* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.\n* Has surgical bowel resection within 3 months of study.\n* Has prior or current gastrointestinal dysplasia.\n* Has chronic infection requiring ongoing antimicrobial treatment.\n* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years.\n* Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n* Has active tuberculosis.\n* Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.\n* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).","16 Years",{"count":166,"type":22},1200,[60],"The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 52 (US\u002FFDA and EU\u002FEMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA).",[170],"Crohn's Disease",{"date":69,"type":40},{"date":173,"type":40},"2024-06-05",{"date":175,"type":22},"2029-11-12",{"name":103,"class":47},499,{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":23,"phases":189,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"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":188,"type":22},385,[25],"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).",[192,170],"Inflammatory Bowel Diseases",[194,195,196,197,198,184],"Crohn's disease (CD)","Inflammatory bowel disease (IBD)","a4b7","Moderate-to-severe","Integrin",{"date":69,"type":40},{"date":201,"type":40},"2024-07-18",{"date":203,"type":22},"2030-06",{"name":205,"class":47},"Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)",225,{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":23,"phases":216,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},"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":215,"type":22},1314,[60],"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.",[219,220],"Metastatic Castration-resistant Prostate Cancer (mCRPC)","Prostatic Neoplasms",{"date":37,"type":40},{"date":223,"type":40},"2023-12-18",{"date":225,"type":22},"2030-12-02",{"name":103,"class":47},330,{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":23,"phases":238,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":248},"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":237,"type":22},868,[60],"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.",[241],"Non-small Cell Lung Cancer",{"date":69,"type":40},{"date":244,"type":40},"2023-12-06",{"date":246,"type":22},"2035-12-21",{"name":103,"class":47},229,{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":256,"enrollmentInfo":257,"targetDuration":4,"studyType":23,"phases":259,"briefSummary":260,"conditions":261,"keywords":263,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":277,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":284},"100509970","phase-3-a-study-evaluating-sotorasib-platinum-doublet-combination-versus-pembrolizumab-platinum-doublet-combination-as-a-front-line-therapy-in-participants-with-stage-iv-or-advanced-stage-iiibc-nonsquamous-non-small-cell-lung-cancers-codebreak-202-100509970","NCT05920356","A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB\u002FC Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)","A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB\u002FC Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing\n* No history of systemic anticancer therapy in metastatic\u002Fnon-curable settings\n* Eastern Cooperative Oncology Group (ECOG) ≤ 1\n\nExclusion Criteria:\n\n* Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology\n* Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy\n* Symptomatic (treated or untreated) brain metastases\n* Gastrointestinal (GI) tract disease causing the inability to take oral medication\n* Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina\n* Prior therapy with a KRAS G12C inhibitor","100 Years",{"count":258,"type":22},750,[60],"The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.",[262],"Non-Small Cell Lung Cancer (NSCLC)",[264,265,96,266,267,268,269,270,271,272,273,274,275,276],"Oncology","Lung Cancer","KRAS p.G12C","Sotorasib","Pembrolizumab","Carboplatin","Pemetrexed","CodeBreaK 202","NSCLC","PD-L1 Negative","AMG 510","LUMAKRAS ®","LUMYKRAS ®",{"date":69,"type":40},{"date":279,"type":40},"2023-11-16",{"date":281,"type":22},"2032-06-29",{"name":283,"class":47},"Amgen",414,{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":23,"phases":294,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":308},"100597898","phase-3-easi-protkt---a-study-to-test-vicadrostat-bi-690517-taken-together-with-empagliflozin-in-people-with-type-2-diabetes-high-blood-pressure-and-cardiovascular-disease-100597898","NCT07064473","EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease","EASi-PROTKT™ - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Type 2 Diabetes, Hypertension and Established Cardiovascular Disease","Inclusion Criteria :\n\n* At least 18 years old at time of consent\n* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n* Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).\n* Participants with medical history of hypertension and on active pharmacological treatment\n* Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment\n* Established cardiovascular (CV) disease and on active pharmacological treatment\n* At least one additional risk factor for developing heart failure (HF)\n\nExclusion Criteria:\n\n* History of HF or hospitalization for HF or treatment of HF\n* Atrial fibrillation or Atrial flutter with a resting heart rate \\>110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)\n* Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)\n* Treatment with an Mineralocorticoid receptor antagonist (MRA)\n* Treatment with amiloride or other potassium-sparing diuretic\n* Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial:\n\n  * A direct renin inhibitor (e.g. aliskiren)\n  * More than one Angiotensin-converting enzyme inhibitor (ACEi) and\u002For Angiotensin receptor blocker (ARB) (including Angiotensin receptor-neprilysin inhibitor (ARNi)) used simultaneously\n  * Other aldosterone synthase inhibitors (e.g. baxdrostat)\n  * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply.",{"count":293,"type":22},11800,[60],"This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine.\n\nParticipants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo.\n\nParticipants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.",[297,298,299],"Diabetes Mellitus, Type 2","Hypertension","Cardiovascular Diseases","2026-08-19",{"date":123,"type":40},{"date":303,"type":40},"2025-07-22",{"date":305,"type":22},"2029-12-21",{"name":307,"class":47},"Boehringer Ingelheim",1147,{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":17,"minAge":316,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":23,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":329},"100583174","phase-3-the-airtivity-study-a-study-to-find-out-whether-bi-1291583-helps-people-with-bronchiectasis-100583174","NCT06872892","The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis","A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of BI 1291583 2.5 mg Administered Once Daily for up to 76 Weeks in Patients With Bronchiectasis (The AIRTIVITY™ Study)","Inclusion criteria:\n\n* Male or female participants. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council of Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1 % per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the participant information.\n* Signed and dated written informed consent and assent, if applicable, prior to admission to the study, in accordance with GCP and local legislation.\n* Age of participants when signing the informed consent\u002Fassent ≥12 years.\n\n  \\-- Adolescents need to weigh at least 35 kg at Visit 1.\n* Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by CT scan where bronchiectasis has been documented by a radiologist.\n\nParticipants whose past CT scan image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than five years.\n\n* Adult participants should be able to produce sputum for Pseudomonas aeruginosa assessment during the screening period.\n* History of documented pulmonary exacerbations (assessed and recorded by the investigator) requiring antibiotic treatment. In the 12 months before Visit 1, participants must have had either:\n\n  * at least 2 exacerbations, or\n  * at least 1 exacerbation and an St. George's Respiratory Questionnaire (SGRQ) Symptoms score of \\>40 at screening Visit 1 (adults only)\n  * at least 1 exacerbation and high symptom burden according to the investigator's judgement (adolescents only) For participants on oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy (CFTR-MT), at least one exacerbation must have occurred since initiation of antibiotics or CFTR-MT.\n\nExclusion criteria:\n\n* Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation.\n* Allergic bronchopulmonary aspergillosis being treated or requiring treatment.\n* Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment\n* Any findings in the medical examination and\u002For laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the participant at risk by participating in the trial.\n* Any clinically relevant (at the discretion of the investigator) acute respiratory infection or ongoing pulmonary exacerbation at screening visit or during the screening unless recovered in the opinion of the investigator prior to Visit 2.\n* Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion of the investigator, may put the participant at risk by participating in the study.\n* Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to randomisation or scheduled during trial period.\n* Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated in situ non-melanoma skin cancers or in situ carcinoma of uterine cervix.\n* Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C hepatic impairment).\n* estimated Glomerular Filtration Rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (adults) or Chronic Kidney Disease Under 25 (CKiD-U25) (adolescents) \\\u003C30 mL\u002Fmin at Visit 1.\n* Previous treatment with a dipeptidyl peptidase-1 (DPP1) (Cathepsin C (CatC)) inhibitor. (Note: Participants that were randomised and only received placebo in studies with DPP1 (CatC) inhibitor are allowed.) Further exclusion criteria apply.","12 Years",{"count":318,"type":22},1755,[60],"This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations).\n\nThe purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months.\n\nParticipants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.",[322],"Bronchiectasis",{"date":123,"type":40},{"date":325,"type":40},"2025-06-09",{"date":327,"type":22},"2027-12-20",{"name":307,"class":47},471,{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":351},"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":338,"type":22},670,[60],"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.",[342,343],"Small Cell Lung Cancer (SCLC)","Extensive-stage Small Cell Lung Cancer (ES-SCLC)","2026-08-18",{"date":300,"type":40},{"date":347,"type":40},"2026-04-13",{"date":349,"type":22},"2029-07-30",{"name":307,"class":47},245,{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":23,"phases":362,"briefSummary":363,"conditions":364,"keywords":366,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":379},"100617436","phase-2-study-of-regn13335-in-adult-participants-with-pulmonary-arterial-hypertension-pah-100617436","NCT07318597","Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN13335, an Anti-PDGF-B Monoclonal Antibody, in Adults With Pulmonary Arterial Hypertension","ILLUMINATE","Key Inclusion Criteria:\n\n1. Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension (WSPH))\n2. WHO functional class II or III (slight to marked limitation of functional status due to PAH)\n3. Receiving background Standard Of Care (SOC) therapy for PAH on a stable dose and regimen, as determined by the investigator, as described in the protocol\n4. PVR ≥400 dynes∙sec\u002Fcm\\^5 (5 Wood units) based on Right Heart Catheterization (RHC) during the screening period\n5. Has 6MWD ≥150 and ≤550 meters repeated twice during screening as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Has Group 2 (PH associated with left heart disease), Group 3 (PH associated with lung diseases and\u002For hypoxia), Group 4 (PH associated with pulmonary artery obstructions), or Group 5 (PH with unclear and\u002For multifactorial mechanisms) PH according to the 7th WSPH\n2. Pulmonary Arterial Wedge Pressure (PAWP) \\>15 mm Hg by RHC during the screening period\n3. History of left-sided heart disease and\u002For clinically significant cardiac disease, as described in the protocol\n4. Obstructive lung disease defined as Forced Expiratory Volume in 1 second (FEV1)\u002FForced Vital Capacity \\\u003C0.7 and FEV1 \\\u003C70% of the predicted value as described in the protocol\n5. Evidence of interstitial lung disease as defined in the protocol\n6. Evidence of chronic thromboembolic pulmonary disease or acute pulmonary embolism as described in the protocol\n7. Participants requiring anticoagulation and\u002For antiplatelet therapy for an underlying medical condition as described in the protocol\n8. Has any history of intracranial bleeding or any history of elevated intracranial pressure\n9. Has any history of bleeding meeting criteria as described in the protocol\n\nNote: Other protocol-defined Inclusion\u002F Exclusion criteria apply",{"count":361,"type":22},99,[25],"This study is researching an experimental drug called REGN13335. The study is focused on participants with Pulmonary Arterial Hypertension (PAH). The aim of the study is to see how safe and effective REGN13335 is in participants with PAH who are taking other PAH medicines.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking REGN13335\n* How much REGN13335 is in the blood at different times\n* Whether the body makes antibodies against REGN13335 (which could make REGN13335 less effective or could lead to side effects)",[365],"Pulmonary Arterial Hypertension (PAH)",[365,367,368,369,370,371],"Pulmonary Hypertension (PH)","Elevated Pulmonary Vascular Resistance (PVR)","World Health Organization (WHO) functional class II or III","Platelet-Derived Growth Factor-B (PDGF-B)","REGN13335",{"date":300,"type":40},{"date":374,"type":40},"2026-05-06",{"date":376,"type":22},"2028-09-17",{"name":378,"class":47},"Regeneron Pharmaceuticals",27,{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":17,"minAge":316,"maxAge":140,"enrollmentInfo":387,"targetDuration":4,"studyType":23,"phases":389,"briefSummary":390,"conditions":391,"keywords":393,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":404},"100614217","phase-3-a-study-to-investigate-gb-0895-adjunctive-therapy-in-adults-and-adolescents-with-severe-uncontrolled-asthma-solairia-1-100614217","NCT07276724","A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma","1. Adults and adolescents ≥ 12 and ≤ 80 years of age.\n2. Documented physician diagnosis of asthma for ≥ 2 years.\n3. Subjects must be on medium to high dose ICS for ≥ 12 months before Screening Visit 1 plus at least 1 additional asthma controller (e.g., LABA, LAMA) ≥ 3 months before Screening Visit 1 with no change in ICS or controller(s) for at least three months.\n4. Subjects must have a well-documented history of at least two asthma exacerbations requiring systemic corticosteroid treatment despite the use of medium-to-high dose ICS in the past 12 months before Screening Visit 1.\n5. Adults ≥ 18 years of age at Screening Visit 1, a pre-BD FEV1 \\\u003C80% predicted at Screening Visit 1.\n6. Adolescents 12 to \\\u003C 18 years of age at Screening Visit 1: A pre-BD FEV1 \\\u003C 90% predicted OR, FEV1:Forced Vital Capacity (FVC) ratio \\\u003C 0.80.\n7. Positive BD responsiveness test: Increase of at least 12% and 200 mL in FEV1 between 15 and 60 minutes after the administration of a short-acting β2-agonist (SABA) at least once during the screening period.\n8. ACQ-6 score ≥ 1.5 at the Screening Visit.\n9. Weight ≥40 kg at the Screening Visit 1\n\nExclusion Criteria:\n\n1. Subjects who experience a clinically significant asthma exacerbation within 12 weeks before the Screening Visit or during the run-in period and require a change in asthma maintenance therapy.\n2. Other concurrent respiratory disease other than asthma, including (but not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, tuberculosis, diagnosis of chronic pulmonary disease (including but not limited to emphysema and\u002For chronic bronchitis), or a history of lung cancer.\n3. Eosinophilic disease (e.g., eosinophilic granulomatosis with polyangiitis, eosinophilic esophagitis).\n4. Any cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could affect subject safety, influence study findings or interpretation, or impede completion of the study.\n5. Clinically significant infection that is unresolved and requires systemic antibiotic, antifungal, antiparasitic, or antiviral medications preceding enrollment.\n6. A current malignancy or previous history of cancer within 5 years before screening.\n7. Clinically significant infection that is not resolved before study enrollment.\n8. Subjects with a known, pre-existing helminth parasitic infestation within 6 months before Screening Visit 1.\n9. Current smokers or subjects with a smoking history ≥10 pack-years, and subjects using vaping products, including electronic cigarettes.\n10. Former smokers with a smoking history of \\\u003C10 pack-years and users of vaping\u002Fe-cigarette products must have stopped for at least 6 months before Screening Visit 1 to be eligible.\n11. Hepatitis B, C, or HIV.\n12. Major surgery within 8 weeks before Screening Visit 1 or planned surgical procedures requiring general anesthesia or inpatient status for \\>1 day during the study.\n13. Use of any anti-IL-5 therapy (e.g., mepolizumab, reslizumab, benralizumab, depemokimab) within 12 months before Screening Visit 1 or other monoclonal antibodies used for asthma within 4 months or 5 half-lives.\n14. Prior use (at any time) of any anti-TSLP or anti-TSLP receptor biologics, approved (e.g., tezepelumab) or investigational.\n15. Treatment with systemic immunosuppressive\u002Fimmunomodulating drugs (e.g., methotrexate, cyclosporine) within 12 weeks prior to randomization.\n16. Receipt of an investigational biologic within 4 months or 5 half-lives, OR receipt of an investigational non-biologic within 30 days or 5 half-lives before Screening Visit 1.\n17. Known history of sensitivity to any component of the study treatment formulation.\n18. History of life-threatening anaphylaxis following any biologic therapy.\n19. Concurrent enrollment in another clinical study involving investigational product (IP).\n20. Subject has been randomized in the current study or previous GB-0895 studies.\n21. Any clinically meaningful abnormal finding in physical examination, vital signs, ECG, hematology, serum chemistry, or urinalysis that, in the opinion of the Investigator, may put the subject at risk, influence study results, or impede study completion.\n22. Cirrhosis (with or without hepatic dysfunction) or other active or clinically significant liver disease.\n23. Receipt of immunoglobulin or blood products within 30 days before Screening Visit 1.\n24. Receipt of live attenuated vaccines within 30 days before randomization and during the study, including the follow-up period.\n25. Receipt of the T2 cytokine inhibitor suplatast tosilate within 15 days before Screening Visit 1.\n26. Subjects treated with bronchial thermoplasty in the last 12 months before Screening Visit 1.\n27. Unwillingness or inability to follow study procedures, including poor adherence to asthma controller medications, in the opinion of the Investigator.\n28. Women who are pregnant, lactating, or planning to become pregnant during the study.\n29. History (or suspected history) of alcohol misuse or substance abuse within 2 years before Screening Visit 1.",{"count":388,"type":22},786,[60],"The objective of this study is to assess the potential for GB-0895 treatment to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers.\n\nThe study details include:\n\nStudy treatment: randomized to receive either GB-0895 or placebo administered every 6 months over 52 weeks.\n\nVisit frequency: every 1-2 months after the first month.",[392],"Severe Asthma",[394,392],"Asthma","2026-08-14",{"date":397,"type":40},"2026-08-17",{"date":399,"type":40},"2025-12-03",{"date":401,"type":22},"2028-12",{"name":403,"class":47},"Generate Biomedicines",78,{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":413,"targetDuration":4,"studyType":23,"phases":415,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":426},"100582074","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-dnth103-in-adults-with-chronic-inflammatory-demyelinating-polyneuropathy-captivate-100582074","NCT06858579","A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)","A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of DNTH103 In Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)","CAPTIVATE","Inclusion Criteria:\n\n1. Must have given written informed consent before any study-related activities are carried out.\n2. Weight range between 40 kilograms (kg) and 120 kg.\n3. Confirmed diagnosis of CIDP or possible CIDP. Participants must have either typical CIDP or one of the following variants: motor or multifocal CIDP. Diagnosis must be confirmed by the Independent CIDP Review Panel.\n4. CIDP Disease Activity Status (CDAS) score ≥ 3 at screening.\n5. Must be neurologically stable.\n6. Must have an INCAT score between 2 and 9 inclusive.\n7. Must fulfill one of the following treatment conditions for CIDP:\n\n   1. Currently treated with and responded to immunoglobulin (Ig) (intravenous immunoglobulin \\[IVIg\\] or subcutaneous immunoglobulin \\[SCIg\\]) alone or Ig (IVIg or SCIg) plus oral corticosteroids, or previously treated with and responded to, but are no longer being treated with (eg, lost access to), a maintenance regimen of Ig (IVIg or SCIg) alone or Ig (IVIg or SCIg) plus oral corticosteroids.\n   2. Currently treated with and responded to oral corticosteroids alone or oral corticosteroids in combination with azathioprine or mycophenolate mofetil.\n   3. Refractory participants who have had treatment failure (worsening) or an inadequate response to Ig and\u002For oral corticosteroids (defined as no clinically meaningful improvement after a period of a minimum of 12 weeks, which may include both active treatment and observation to assess response), or who at any time were unable to tolerate these treatments, experienced adverse effects, or have documented contraindications.\n   4. Treatment naïve with no history of prior treatment for CIDP.\n8. Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.\n9. Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.\n10. Male participants must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception or be surgically sterile for at least 90 days prior to Screening.\n\nExclusion Criteria:\n\n1. Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.\n2. Known evidence of central demyelination or known history of myelopathy.\n3. History or presence of significant medical\u002Fsurgical condition including any acute illness or major surgery considered to be clinically significant or that could have a potential impact on safety\u002Fefficacy or study procedures.\n4. Any other condition, including mental illness or prior therapy that would make the participant unsuitable for this study.\n5. Known complement deficiency or history of positive titer for anti-C1 antibodies.\n6. Diagnosis of systemic lupus erythematosus (SLE) or family history of SLE (defined as a parent, sibling, or child).\n7. Participants with an autoimmune disease affecting joints, muscle or nervous system.\n8. Any coexisting or overlapping condition, which may interfere with outcome assessments, such as severe diabetic neuropathy, fibromyalgia, inflammatory arthritis or osteoarthritis affecting the hands and feet.\n9. Prior history of N. meningitidis infection.\n10. History of active malignancy within 5 years prior to screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone.\n11. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.",{"count":414,"type":22},256,[60],"The purpose of this Phase 3 study is to demonstrate the efficacy of claseprubart (DNTH103) as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).",[418],"Chronic Inflammatory Demyelinating Polyneuropathy",{"date":344,"type":40},{"date":421,"type":40},"2025-02-10",{"date":423,"type":22},"2030-12-31",{"name":425,"class":47},"Dianthus Therapeutics",188,{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":434,"minAge":18,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":23,"phases":437,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":454},"100613856","office-massage-effects-on-hrv-and-stress-100613856","NCT07272031","Office Massage Effects on HRV and Stress","Randomized Controlled Trial to Evaluate the Effectiveness of Three Different 15-Minute Office Massage Types (Head, Cervical Area, Hand) on Autonomic Nervous System Balance and Chronic Stress Reduction Using Heart Rate Variability (HRV)","Inclusion Criteria:\n\nBiological females aged 18 years or older. Currently working in an office job with at least 75% of the working day spent sitting (sedentary work).\n\nSelf-reported regular menstrual cycle (cycle length 21-35 days). Able to attend all scheduled intervention sessions (8 sessions over 4 weeks). Able to provide informed consent to participate in the study.\n\nExclusion Criteria:\n\nCurrent pregnancy or breastfeeding. Diagnosis of cardiovascular diseases (e.g., heart failure, cardiac arrhythmias, deep vein thrombosis) or presence of a pacemaker Endocrine or metabolic disorders (e.g., insulin-dependent diabetes, hyperthyroidism, or other thyroid dysfunctions) Active cancer or receiving active cancer treatment (e.g., chemotherapy, radiation therapy) History of major surgery or trauma in the head, neck, or upper extremities within the last 3 months Current diagnosis of a major psychiatric disorder (e.g., major depressive disorder, bipolar disorder) Regular use of medications affecting heart rate or the nervous system (e.g., beta-blockers, ACE inhibitors, antidepressants, anxiolytics, or asthma inhalers) Current participation in another interventional clinical trial","FEMALE",{"count":436,"type":22},140,[438],"NA","This study is a randomized controlled trial designed to investigate which of three short office massage types (head, neck\u002Fshoulder area, or hand) is most effective for reducing chronic stress in women who perform sedentary office work.\n\nMany sedentary female office employees experience long-term tension and work-related strain, which can affect the body's ability to recover. The investigators are testing whether a 15-minute massage, performed twice a week for four weeks, can help restore balance within the body.\n\nThe investigators will evaluate the impact of these massages using Heart Rate Variability (HRV)-an objective measure that shows how well the body manages stress (autonomic nervous system balance)-as well as analyzing participants' self-reported levels of perceived stress, sleep quality, and overall well-being. Participants receiving massage will be compared to a control group engaging in quiet rest.",[441,442,443],"Occupational Health","Autonomic Nervous System (ANS) Functioning and Mood State","Stress","2026-08-12",{"date":446,"type":40},"2026-08-13",{"date":448,"type":40},"2026-01-05",{"date":450,"type":22},"2026-09-30",{"name":452,"class":453},"Riga Stradins University","OTHER",1,{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":23,"phases":465,"briefSummary":466,"conditions":467,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":477},"100579322","phase-3-long-term-safety-and-efficacy-of-plozasiran-in-adults-with-hypertriglyceridemia-100579322","NCT06822790","Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia","A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia (SHASTA-10 Study)","SHASTA-10","Inclusion Criteria:\n\n* Adult males, or nonpregnant (who do not plan to become pregnant), nonlactating adult females, who are able and willing to provide written informed consent prior to the performance of any study-specific procedures\n* Completed all required study visits per protocol in the parent study\n* Female subjects of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 90 days after the End of Study (EOS) or the last dose of plozasiran, whichever is later. Male subjects must agree to use a condom during the study and for at least 90 days after the EOS or last dose of plozasiran whichever is later. Subjects must not donate sperm or eggs during the study and for at least 90 days after the EOS or last dose of plozasiran, whichever is later. Female subjects of childbearing potential on hormonal contraceptives must be stable on medication for \\>1 menstrual cycle prior to Day 1.\n* Subjects must be on standard of care lipid and TG-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator, including an inability to safely administer or re-administer a specific drug because of fear, preference, genetic, clinical, or metabolic considerations, or due to a previous adverse reaction associated with, attributed to, or caused by specific drug)\n* If the subject has a medical history of clinical atherosclerotic cardiovascular disease (ASCVD) or elevated 10-year ASCVD risk (eg, ≥7.5% per American Heart Association\u002FAmerican College of Cardiology \\[AHA\u002FACC\\] risk calculator for subjects ≥40 years of age or Framingham risk score calculator for subjects under the age of 40), the subject must be on appropriate lipid-lowering therapy as per local standard of care (ie, including moderate-to-high intensity statin, as indicated).\n\nIf the subject has diabetes:\n\n1. Subject must be on optimized antidiabetic regimen as defined by the local standards, Investigator, and institutional practices\n2. Subject must have no events of diabetic ketoacidosis, diabetic decompensation\u002F hyperosmolar hyperglycemic nonketotic coma, diabetes complications, recurrent infections, or hospitalization related to poor glycemic control within 24 weeks of the Day 1 visit - Willing to follow diet counseling and maintain a stable low-fat diet\n\nSubjects in the USA and Canada who completed protocol AROAPOC3-2003 meeting all eligibility criteria (with the exception of inclusion criteria #9 which is not applicable to these subjects) who also meet the following additional criteria may enroll in this trial:\n\n* HbA1c ≤10% within 30 days prior to Day 1\n* Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND either (c) or (d) below:\n* Baseline fasting TG level of ≥500 mg\u002FdL and prior history of acute pancreatitis at the time of enrollment into AROAPOC3-2001\n* Baseline fasting TG level of ≥1000 mg\u002FdL at the time of enrollment into AROAPOC3-2001\n\n  * Subjects who previously met all eligibility requirements for AROAPOC3-3003, or AROAPOC3-3004 and were not permitted to proceed to randomization per Sponsor's direction in order to prevent excessive over-enrollment may also be enrolled in this trial. These subjects must meet all eligibility criteria prior to enrollment (with the exception of inclusion criteria #2 and #8 which are not applicable to these subjects) and have an HbA1c ≤10% within 30 days of Day 1.\n\nExclusion Criteria:\n\n* Subject was permanently discontinued from receiving plozasiran in the parent study due to elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or due to HbA1c elevation that did not respond to antidiabetic regimen\n* Subject withdrew consent for continued study treatment in the parent study\n* Known hypersensitivity to the active substance or to any of the excipients of plozasiran\n* Known hypersensitivity to the active substance or to any of the excipients of plozasiran\n* Any new condition or worsening of existing condition or any other situation that in the Investigator's judgment, would make the subject unsuitable for enrollment, could interfere with the subject participating in or completing the study, would make it difficult to comply with protocol requirements, or put the subject at an additional safety risk\n* Unwilling to limit alcohol consumption to within moderate limits for the duration of the study.\n* Poorly controlled glycemia (ie, HbA1c \\>10%) based upon the most recent HbA1c level reported in the parent trial prior to Day 1\n* Acute pancreatitis within 4 weeks prior to Day 1\n* Use of any hepatocyte-targeted siRNA that targets lipids and\u002For triglycerides within 365 days before Day 1 (except plozasiran or inclisiran, which are permitted). Administration of inclisiran must be separated from administration of plozasiran by at least 4 weeks throughout the treatment period\n* Use of any other hepatocyte targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5 half-lives before Day 1 based on plasma PK, whichever is longer.\n* Use of an investigational agent (other than plozasiran) or device within 30 days or within 5 half-lives, based on plasma PK, whichever is longer, prior to Day 1 (V1) or current participation in an interventional investigational study.\n* Recent unstable or symptomatic cardiac arrhythmia (including any associated medication changes) within 90 days prior to Day 1. Individuals with stable well-controlled atrial arrhythmias will be allowed to participate in the study.\n* Uncontrolled hypertension (ie, seated systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg) at Day 1; subject may be re-evaluated when hypertension is controlled.\n\nNote: Other inclusion\u002Fexclusion criteria may apply per protocol",{"count":464,"type":22},869,[60],"This is an open-label study to be conducted in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (SHTG). Each participant must have completed all required visits per protocol in the parent study AROAPOC3-2003 (USA and Canada participants only; NCT# 05413135), AROAPOC3-3001(Canada and Japan participants only; NCT05089084), AROAPOC3-3003 (NCT06347003), AROAPOC3-3004 (NCT06347016) or AROAPOC3-3009 (Argentina, Italy, South Africa, and Spain; NCT06347133).\n\nSubjects who previously met all eligibility requirements for AROAPOC3-3003 or AROAPOC3-3004 and were not permitted to proceed to randomization per the Sponsor's direction in order to prevent excessive over-enrollment may also be enrolled in this trial. The subjects must meet all other applicable eligibility criteria prior to enrollment and have an HbA1c results of \\\u003C=10% within 30 days prior to Day 1.\n\nSubjects entering this OLE from AROAPOC3-2003 must meet the following additional criteria to be considered for enrollment in addition to applicable eligibility criteria:\n\n1. HbA1c ≤10% within 30 days prior to Day 1\n2. Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND fulfill either (c) or (d)\n3. Baseline fasting TG level of ≥500 mg\u002FdL and prior history of acute pancreatitis at the time of enrollment into AROAPOC3-2001\n4. Baseline fasting TG level of ≥1000 mg\u002FdL at the time of enrollment into AROAPOC3-2001\n\nAll eligible participants will receive plozasiran administered subcutaneously (SC) approximately every 3 months for 24 months. Participants will be counseled to remain on the specified low-fat diet throughout the study in accordance with local standard of care.",[468],"Hypertriglyceridemia","2026-08-11",{"date":444,"type":40},{"date":472,"type":40},"2025-04-09",{"date":474,"type":22},"2028-07",{"name":476,"class":47},"Arrowhead Pharmaceuticals",255,{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":23,"phases":487,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":502},"100609925","phase-3-supporting-weak-immune-system-during-autoimmune-therapy-testing-panzyga-to-prevent-infections-100609925","NCT07220915","Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients With Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment With B-cell Depletion Therapy (\"PROTECT\")","Inclusion Criteria:\n\nPatients who meet all of the following criteria will be eligible to participate in the study:\n\n1. Are ≥18 years of age at time of informed consent, have been diagnosed with a rheumatic or autoimmune condition, received their last BCDT dose within 3 months of Screening, and have the intention to receive BCDT during study participation. Note: Patients with the following indications are eligible: MS, RA, vasculitis\u002Fmyositis, SLE, SS, IIM, MCTD, UCTD, myasthenia gravis, autoimmune encephalitis, CIDP, and neuromyelitis optica spectrum disorder). Other rheumatic and autoimmune conditions may also be acceptable with approval from the Medical Monitor.\n2. Have hypogammaglobulinemia (IgG levels \\\u003C5 g\u002FL as confirmed by the central laboratory).\n3. Are willing and able to provide voluntary written informed consent for participation in the study and to comply with all protocol requirements..\n4. Are willing and able to comply with a highly effective contraception method during and for 30 days after the treatment period. Contraceptive use by men and women of childbearing potential should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from participation in the study:\n\n1. Have a history of anaphylaxis or severe systemic response to immunoglobulin, blood, or plasma-derived products, or any Panzyga component\n2. Have a current major infection at Screening or had \\>1 major infection within 6 months prior to Baseline\n3. Have a history of thromboembolic events such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, or peripheral artery disease (Fontaine IV) within 6 months prior to Baseline\n4. Have a known IgA deficiency with antibodies to IgA\n5. Have a known blood hyperviscosity or other hypercoagulable states\n6. Have been diagnosed with primary immunodeficiency.\n7. Have a severe liver disease, with signs of ascites or hepatic encephalopathy\n8. Have a severe kidney disease (as defined by eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2)\n9. Have a body weight \\>140 kg\n10. HIV infection at Screening (defined for the study as positive HIV NAT test or reactive HIV- 1\u002F2 antigen\u002Fantibody immunoassay followed by positive HIV-1\u002FHIV-2 antibody differentiation immunoassay)\n11. Patients found to be chronic carriers of hepatitis B virus (HBV), defined by positive surface antigen (HBsAg), positive Hepatitis B core antibodies (HBcAb) and\u002For low HBV titers, who will not receive targeted antiviral therapy while participating in the study, and patients with active HBV, defined as high HBV titers.\n12. Uncontrolled hepatitis C infection at Screening (defined for the study as positive HCV PCR).\n13. Have received IgG treatment within 6 months prior to Screening or plan to receive IgG therapy, other than IMP, during the study\n14. Are receiving or plan to receive immunosuppressive treatment (other than for underlying condition) or other forbidden medication during the entire study duration\n15. Are participating or plan to participate in another study that is either blinded or involves an investigational medicinal product within 3 months prior to Baseline or during the course of this study. Participation in observational or open-label studies involving an approved product may be permitted after consultation with the Medical Monitor.\n16. If female, are pregnant or lactating\n17. Are likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem or poor mental development, in the opinion of the Investigator",{"count":486,"type":22},360,[60],"A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment with B-cell Depletion Therapy",[490,491,492,493],"Hypogammaglobulinemia","Autoimmune Conditions","Rheumatic Conditions","Infections","2026-08-10",{"date":444,"type":40},{"date":497,"type":40},"2026-06-10",{"date":499,"type":22},"2029-12",{"name":501,"class":47},"Octapharma",6,{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":140,"enrollmentInfo":511,"targetDuration":4,"studyType":23,"phases":513,"briefSummary":514,"conditions":515,"keywords":517,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":529,"locationsCount":531},"100606398","a-study-of-roc-101-in-patients-with-pulmonary-arterial-hypertension-pah-and-pulmonary-hypertension-associated-with-interstitial-lung-disease-ild-ph-rocstar-study-100606398","NCT07175038","A Study of ROC-101 in Patients With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (ILD-PH) (ROCSTAR STUDY)","A Phase 2A, Open-Label Single Arm Multicenter Exploratory Study to Evaluate the Safety, Tolerability, and Efficacy of Oral Doses of ROC-101 in Patients With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (ILD-PH).","ROCSTAR","Key Inclusion Criteria:\n\n1. Must be age 18 or older at the time of signing the informed consent form (ICF). The participant must understand and voluntarily sign an ICF prior to any study-related procedures\n2. Documented findings on a right heart catheterization (RHC) consistent with a diagnosis World Health Organization (WHO) Group 1 PAH or WHO GROUP 3 PAH\n3. Symptomatic Pulmonary Hypertension (PH) classified as WHO Functional Class II or III symptoms\n4. PAH participants: Pulmonary Vascular Resistance (PVR) of ≥ 5 Wood units (≥ 400 dynes\u002Fsec\u002Fcm-5) and, Pulmonary Capillary Wedge Pressure (PCWP) ≤ 15 mmHg and Mean Pulmonary Arterial Pressure (mPAP) \\> 20 mm Hg and ILD-PH participants: PVR of ≥ 3 Wood units (≥ 240 dynes\u002Fsec\u002Fcm-5) with a maximum enrollment of 5 participants with PVR between 3 and 4 Wood units inclusive (240-320 dynes\u002Fsec\u002Fcm-5 inclusive) and the remaining 5 participants must have PVR \\>4 Wood units (\\> 320 dynes\u002Fsec\u002Fcm-5) and, PCWP ≤ 15 mmHg and mPAP \\> 20 mm Hg\n5. Participants on stable background therapy for PAH or ILD-PH.\n6. Females of childbearing potential (as defined in protocol) must agree to use highly effective contraception (as defined in the protocol)\n7. Male participants must follow protocol-specified contraception guidance.\n8. Participants must be able to communicate well with Investigators, understand the study procedures in the ICF and are agreeable to complete the study in accordance with the protocol.\n9. Must be able to swallow tablets.\n10. Pulmonary function tests (PFT):\n\n    PAH participants at Screening as follows:\n    1. Forced Vital Capacity (FVC) \\> 70% predicted; or if between 60% to 70% predicted, or if not possible to be determined, confirmatory High-Resolution Computed Tomography (HRCT) indicating no more than mild (\\\u003C10% fibrosis) ILD and emphysema (less than 10%); and\n    2. The ratio of FEV1 (first second)\u002FFVC \\> 0.70 of predicted.\n\n    ILD-PH participants at Screening as follows:\n    1. PFTs consistent with their ILD diagnosis and showing FEV1\u002F FVC ratio \\> 65% and HRCT having more than 10% fibrosis and less than 10% emphysema, based on the proportion of lung parenchyma affected by fibrotic and emphysema changes.\n\n       and,\n    2. Minimum FVC of 50% and diffusing capacity for carbon monoxide (DLCO) (corrected for Hb g\u002Fdl) \\>25%\n11. In PAH participants, i.e., Cohorts 1 and 2 only, ventilation-perfusion (VQ) scan (or, if unavailable, a negative Computed tomography pulmonary angiogram \\[CTPA\\] or pulmonary angiography result), any time prior to Screening or conducted during the Screening Period, with a normal or low probability result that is not clinically significant\n12. Acceptable Electrocardiogram (ECG) findings as assessed by the Investigator or qualified designee at the Screening Visit and at the Baseline Visit (Day 1), including each criterion as listed below:\n\n    * Normal sinus rhythm (HR) between 40 and 100 beats per minute, inclusive);\n    * Corrected QT Interval (QTcF) interval ≤ 450 msec (males) and ≤ 460 msec (females);\n    * QRS interval ≤ 120 msec; if \\> 120 msec, result will be confirmed by a manual overread\n13. Body weight at the Screening visit and at Baseline (Day 1) is greater than 50.0 kg and the body mass index (BMI) is in the range of 19.00 to 36.00 kg\u002Fm2, inclusive\n14. 6MWD ≥ 100 and ≤ 550 meters repeated twice, once during Screening Period and once at the Baseline Visit (Day 1) and both values within 15% of each other, allowing for a third repeat if \\> 15% difference, calculated from the higher\u002Fhighest value\n\nKey Exclusion Criteria:\n\n1. Diagnosis of PH WHO Groups 2, 4, or 5\n2. Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH and pulmonary veno-occlusive disease and\u002For pulmonary capillary hemangiomatosis\n3. Positive blood test for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody (HCVAb) (unless participants have had treatment for HCV and have a negative HCV ribonucleic acid \\[RNA\\] polymerase chain reaction \\[PCR\\]) or HIV antibody\n4. Participants with known hypersensitivity to ROC-101 or any components of its formulations\n5. History of malignancy within the last 5 years, with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤ 2 squamous cell carcinomas of the skin\n6. History of clinically significant (as determined by the Investigator) non-PAH related cardiac, endocrine, hematologic, hepatic, immune, metabolic, urologic, pulmonary, neurologic, neuromuscular, dermatologic, psychiatric, renal, and\u002For other diseases that may limit participation in the study\n7. Participation in another clinical trial involving intervention with another investigational drug, approved therapy for investigational use, or investigational device within 4 weeks prior to Baseline Visit (unless it is in the follow-up period of an interventional study), or if the half-life of the previous product is known, within 5× the half-life prior to Baseline Visit (Day 1), whichever is longer\n8. Major surgery within 8 weeks prior to Baseline Visit (Day 1) or major surgery scheduled or planned in the main study. Participants must have completely recovered from any previous surgery prior to the Screening Visit\n9. Prior heart or heart-lung transplants, or a participant listed for heart and\u002For lung transplantation or prior pneumonectomy\n10. Pregnant or breastfeeding females\n11. Males who do not agree to protocol contraception guidelines\n12. Uncontrolled systemic hypertension as evidenced by sitting SBP \\> 160 mm Hg or sitting diastolic BP \\> 100 mm Hg during Screening Visit and Baseline Visit (Day 1) after a period of rest\n13. Systolic BP \\\u003C 90 mm Hg during Screening Visit or at Baseline Visit (Day 1) or, if during screening, orthostatic systolic BP decreases by more than 20 mm Hg and the participant is symptomatic.\n14. History of known pericardial constriction or a clinically significant (more than trace or trivial \\[i.e., ≥10 mm\\]) pericardial effusion seen in diastole or in both systole and diastole on echocardiogram (ECHO) historically and confirmed on screening ECHO\n15. RHC contraindicated during the study per Investigator\n16. Cerebrovascular accident within 3 months (120 days) of start of Screening\n17. History of restrictive or constrictive or congestive cardiomyopathy\n18. Left ventricular ejection fraction (LVEF) \\\u003C 50% on historical echocardiogram (ECHO) performed within 6 months prior to start of Screening period (and confirmed during the Screening ECHO) or grade 2 or higher diastolic dysfunction\n19. Any current symptomatic coronary disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain in the past 6 months (180 days) prior to start of Screening)\n20. History of acutely decompensated left heart failure or right heart failure within 90 days prior to Baseline, as per Investigator assessment\n21. Significant (≥ 2+ \\[or \\> mild\\] regurgitation) mitral regurgitation or aortic regurgitation valvular disease, or more than mild mitral stenosis or aortic stenosis valvular disease as seen on Screening ECHO\n22. Started or stopped receiving any general supportive therapy for PH (e.g., oxygen, anticoagulants, digoxin) within 30 days prior to start of Screening\n23. Use of supplemental oxygen \\> 10 liters\u002Fminute or and SpO2 \\\u003C 90% while receiving typical oxygen supplementation, unless living at \\> 1000 meters altitude above sea level in which SpO2 cannot be lower than 85% while receiving typical oxygen supplementation\n24. Received intravenous (IV) inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to start of Screening\n25. History of atrial septostomy within 180 days prior to start of Screening\n26. History of portal hypertension or chronic liver disease, defined as mild to severe hepatic impairment (Child-Pugh Classes A to C)\n27. Untreated, severe (defined as apnea hypoxia index of \\> 30) obstructive sleep apnea\n28. Active daily smoker of cannabis or tobacco\n29. Current alcohol abuse or current illicit drug use\n30. WHO Group 3 due to severe chronic obstructive pulmonary disease (COPD) or chronic pulmonary fibrosis and emphysema (CPFE) or PFT with FVC \\\u003C 50% or FEV1\u002FFVC \\\u003C 65% or DLCO \\\u003C 25% (corrected for Hb g\u002Fdl)\n31. Presence of lab abnormalities at Screening\n32. History of greater than severe renal disease, including any episode of acute renal failure, with or without a prior history of renal disease in which acute dialysis (e.g., intermittent hemodialysis or continuous veno-venous hemofiltration) was required\n33. Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to Baseline or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible)\n34. Participants who plan to continue, or start during the study, medications which are sensitive cytochrome (CYP) 2D6 substrates with a narrow therapeutic index, such as nortriptyline, venlafaxine, and amitriptyline or CYP1A2 substrates with a narrow therapeutic index\n35. History or presence of impaired cardiac function\n36. Participants who plan to donate blood after signing consent for the study and for 28 days after their last dose of study drug\n\nKey Inclusion Criteria for Long-term Extension Period:\n\n1. Participants must complete the main study period (defined as completion of assessments through the Week 24 visit)\n2. Women of child-bearing potential (WOCBP) must have negative pregnancy test\n3. All participants must comply with contraceptive guidance until 28 days after last dose of study drug for WOCBP and 90 days after the last dose of study drug for males\n\nKey Exclusion Criteria for Long-term Extension Period:\n\n1. Participant withdrew from main study period due to an AE related to study drug\n2. Female participant who is pregnant, breastfeeding, or intends to conceive during the long-term extension period\n3. Males who do not agree to follow protocol contraception guidelines\n4. Any condition that in the opinion of the investigator may pose a risk to the participant, interferes with the participant's participation or confounds assessments of the participant",{"count":512,"type":22},40,[25],"This study evaluates the effect of ROC-101 in adults with either Pulmonary Arterial Hypertension (PAH) or Pulmonary Hypertension Associated with Interstitial Lung Disease (ILD-PH). Each eligible participant will receive standard of care (SOC) plus ROC-101 for a 24-week treatment period, followed by a long-term extension period of the study through the end of the program or marketing approval\u002Fauthorization.",[365,516],"Pulmonary Hypertension, Interstitial Lung Disease",[518,519,520,521,522,523,365,516],"Rho kinase inhibitor","ROCK inhibitor","Pan ROCK Inhibitor","ROCK-1 and ROCK-2 Inhibitor","ROC-101","PVR","2026-08-07",{"date":494,"type":40},{"date":527,"type":40},"2025-10-01",{"date":74,"type":22},{"name":530,"class":47},"AllRock Bio, Inc.",23,{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":23,"phases":541,"briefSummary":542,"conditions":543,"keywords":545,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":551,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":558},"100590100","nbi-1065845-mdd3026-study-to-assess-the-efficacy-and-safety-of-nbi-1065845-as-an-adjunctive-treatment-in-participants-with-major-depressive-disorder-mdd-100590100","NCT06963021","NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)","A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)","Key Inclusion Criteria:\n\n* Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.\n* Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.\n* Participant must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.\n* Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).\n* Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.\n\nKey Exclusion Criteria:\n\n* A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.\n* Are considered by the investigator to be at imminent risk of suicide or injury to self or others.\n* Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.",{"count":540,"type":22},200,[60],"The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.",[544],"Major Depressive Disorder",[546,547,544,548,549,550],"MDD","Depression","NBI-1065845","TAK-653","MADRS",{"date":494,"type":40},{"date":553,"type":40},"2025-05-30",{"date":555,"type":22},"2027-07",{"name":557,"class":47},"Neurocrine Biosciences",35,{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":23,"phases":568,"briefSummary":569,"conditions":570,"keywords":572,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":577,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":426},"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":567,"type":22},1088,[60],"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.",[571],"Psoriatic Arthritis",[573,574,575,576],"Drug Therapy","Latitude Research Program","Latitude PsA","Latitude PsA-3001",{"date":469,"type":40},{"date":579,"type":40},"2025-03-03",{"date":581,"type":22},"2028-01-28",{"name":583,"class":47},"Takeda",{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":4,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":17,"minAge":591,"maxAge":592,"enrollmentInfo":593,"targetDuration":4,"studyType":23,"phases":595,"briefSummary":596,"conditions":597,"keywords":599,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":594},"100566839","a-phase-3-placebo-controlled-study-to-investigate-lp352-in-children-and-adults-with-dravet-syndrome-ds-100566839","NCT06660394","A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy, Safety, and Tolerability of LP352 in the Treatment of Seizures in Children and Adults With Dravet Syndrome","Inclusion Criteria:\n\n* Diagnosis of DS must fulfill all of the following criteria:\n\n  1. Participants with seizure onset age \\>1 and \\\u003C20 months\n  2. The participant has a history of at least 1 of the following seizure type(s): prolonged generalized tonic-clonic, hemiclonic, myoclonic, tonic, atonic, atypical absence, focal impaired awareness, nonconvulsive status epilepticus\n* The participant has a current occurrence of at least 1 of the following countable motor seizure types: generalized tonic-clonic, tonic (bilateral), clonic (bilateral), atonic (bilateral) with truncal\u002Fleg involvement, focal motor (including hemiclonic), and focal to bilateral tonic-clonic\n* The participant has demonstrated an average of at least 4 countable motor seizures per month for the 3 months prior to Screening.\n* The participant has been taking 1 to 4 antiseizure medications (ASMs) at a stable dose for at least 4 weeks prior to Screening.\n* The participant, parent, or caregiver is willing and able (in the judgment of the investigator) to comply with completion of the diaries throughout the study.\n* The participant must be willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* The participant has a history of infantile\u002Fepileptic spasms.\n* The participant has been admitted to a medical facility for treatment of status epilepticus requiring mechanical ventilation within 3 months prior to Screening.\n* The participant has a neurodegenerative disorder as indicated by magnetic resonance imaging or genetic testing.\n* The participant has an acquired lesion\u002Finjury unrelated to the primary etiology that could contribute as a secondary cause of seizures.\n* The participant is receiving exclusionary medications.\n* The participant is currently using any cannabis product or cannabidiol that is not in oral solution\u002Fcapsule\u002Ftablet form, not obtained from a government-approved dispensary, or contains ≥50% Delta-9-tetrahydrocannabinol (THC).\n* The participant has unstable, clinically significant neurologic (other than the disease being studied, eg, recurrent strokes), psychiatric, cardiovascular (eg, pulmonary arterial hypertension, cardiac valvulopathy, orthostatic hypotension\u002Ftachycardia), pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.\n* The participant is unwilling to comply with any of the study requirements or timelines.","2 Years","65 Years",{"count":594,"type":22},104,[60],"This (DEEp SEA Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DS. The study consists of 3 main phases: Screening, Titration period, and Maintenance period, followed by a Taper period and Follow-Up. Participants will be randomized to LP352 or placebo. The total duration of the study will be approximately 24 months.",[598],"Dravet Syndrome",[600,601,602,603,604,605,606,607],"Antiseizure medication","Epilepsy","Neurodevelopmental disorders","Developmental and epileptic encephalopathy","LP352","Seizures","DEEp SEA","Bexicaserin",{"date":494,"type":40},{"date":610,"type":40},"2024-09-25",{"date":612,"type":22},"2026-10-02",{"name":614,"class":47},"Longboard Pharmaceuticals",{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":621,"eligibilityCriteria":622,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":623,"targetDuration":4,"studyType":23,"phases":625,"briefSummary":626,"conditions":627,"keywords":629,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":648},"100603719","axillary-radiotherapy-or-axillary-lymph-node-dissection-in-patients-with-clinically-node--positive-breast-cancer-undergoing-upfront-tailored-axillary-surgery-100603719","NCT07140172","Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery","Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery: An International, Randomized Superiority Trial (OPBC-10\u002F NOAX)","OPBC-10\u002F NOAX","Inclusion Criteria at screening:\n\n* Written informed consent according to ICH\u002FGCP regulations prior to any trial specific procedures.\n* Patients ≥ 18 years of age.\n* Node-positive breast cancer (histologically or cytologically proven both in primary tumor and in lymph node) American Joint Committee on Cancer\u002F International Union Against Cancer (AJCC\u002FUICC) stage II-III (all molecular subtypes allowed).\n* Node-positivity detected by imaging and non-palpable (iN+) and confirmed by pathology.\n* Node-positivity palpable (cN1-3) and confirmed by pathology.\n* Occult breast cancer is allowed, if biopsy-proven axillary lymphatic metastasis is present.\n* Eligible for primary ALND or SLN procedure and either:\n\n  * Newly diagnosed.\n  * Isolated in-breast recurrence or second ipsilateral breast cancer after previous breast conserving surgery and sentinel procedure and at least 3 years disease free and no prior axillary dissection or axillary RT.\n* Upfront surgery setting.\n* Most suspicious axillary lymph node clipped. (If clipping is not part of the routine, this should be done after consent of the patient as a study procedure.)\n* Ability to complete the QoL questionnaires.\n* WHO performance status 0-2\n* Adequate condition for general anesthesia, breast cancer surgery and radiotherapy.\n* Adult patients (≥18 years of age).\n* Women of child-bearing potential are using effective contraception (condom, diaphragm, intrauterine device), are not pregnant or lactating and agree not to become pregnant during trial treatment (until end of RT) and thereafter during the time recommended by the guidelines - also for adjuvant systemic therapies. A negative pregnancy test before registration is required for all women of child-bearing potential.\n* Men agree not to father a child during trial treatment and for 6 months afterward.\n\nExclusion criteria at screening:\n\n* Stage IV breast cancer.\n* Clinical N3c breast cancer without axillary disease (clinical N3a and clinical N3b are allowed).\n* Clinical N2b breast cancer (clinical N2a is allowed).\n* Contralateral breast cancer within 3 years.\n* Prior axillary surgery (except prior sentinel node procedure in case of in-breast recurrence).\n* Prior regional radiotherapy.\n* Neoadjuvant treatment with the exception of bridging therapy given for less than 3 months.\n* History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from pre-registration with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer.\n* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.\n\nExclusion criteria at randomization (intraoperatively):\n\n* Absence of clip in the specimen radiography.\n* Palpable disease left behind in the axilla after TAS.\n* No SLN identified in the axilla.",{"count":624,"type":22},1060,[438],"This trial is to investigate if in patients with clinically node positive breast cancer undergoing upfront surgery, treatment with TAS and ART is superior to ALND in terms of arm-related Quality of Life (QoL) and occurrence of lymphedema two years after randomization.",[628],"Breast Cancer",[630,631,632,633,634,635,636,637,638,639],"axillary lymph node dissection (ALND)","axillary radiotherapy (ART)","tailored axillary surgery (TAS)","clinically node positive breast cancer (cN+ BC)","sentinel lymph node biopsy (SLNB)","Breast cancer-specific survival (BCSS)","NOAX","OPBC-10","Lymphedema","Quality of life (QoL)","2026-08-06",{"date":524,"type":40},{"date":643,"type":40},"2026-01-01",{"date":645,"type":22},"2037-12",{"name":647,"class":453},"University Hospital, Basel, Switzerland",54,{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":655,"eligibilityCriteria":656,"healthyVolunteers":12,"sex":17,"minAge":657,"maxAge":140,"enrollmentInfo":658,"targetDuration":4,"studyType":23,"phases":660,"briefSummary":661,"conditions":662,"keywords":664,"overallStatus":667,"whyStopped":4,"lastUpdateSubmitDate":668,"lastUpdatePostDateStruct":669,"startDateStruct":671,"completionDateStruct":673,"leadSponsor":675,"locationsCount":677},"100620685","study-aiming-to-test-whether-non-invasive-liquid-biopsies-can-safely-reduce-invasive-surveillance-methods-in-lynch-syndrome-100620685","NCT07360834","Study Aiming to Test Whether Non-invasive Liquid Biopsies Can Safely Reduce Invasive Surveillance Methods in Lynch Syndrome","Predicting Cancer Onset in Lynch Syndrome by Liquid Biopsies","PREDI-LYNCH","Inclusion Criteria:\n\n1. Participant must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.\n2. Age 35-80\n3. Genetically confirmed class 4-5 (likely pathogenic (LP) or pathogenic (P) variant, respectively) in MLH1, MSH2, MSH6, or EPCAM gene.\n4. The participant should be insurance covered for the financial costs of the standard surveillance and healthcare related to LS, such as affiliated to Social Security System\n\nExclusion Criteria:\n\n1. Previously performed proctocolectomy or equivalent (entire colon and rectum removed)\n2. Active treatment for cancer within 2 years prior to inclusion.\n3. Checkpoint inhibitor therapy within 12 months\n4. Pregnancy\n5. Participants unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.\n6. Persons deprived of their liberty or under protective custody or guardianship.","35 Years",{"count":659,"type":22},2000,[438],"Lynch syndrome is an inherited genetic predisposition that increases the risk of developing several types of cancer, particularly colon and rectal cancers (colorectal cancer), as well as cancer of the uterine lining (endometrial cancer). It affects around 1 in 400 people in Europe.\n\nToday, surveillance mainly relies on examinations such as colonoscopy (an examination of the colon using a camera) or gynaecological evaluations, sometimes accompanied by biopsies (the removal of a small tissue sample for microscopic analysis). Although effective, these procedures are invasive and demanding; they can affect quality of life and discourage some individuals from adhering to their recommended surveillance programme.\n\nThe European project PREDI-LYNCH is exploring an additional pathway that is simpler and better tolerated. This project relies on \"liquid biopsies\", meaning tests performed on easily collected samples such as blood, urine, stool, and vaginal swabs for women with a uterus. The PREDI-LYNCH study aims to determine whether these non-invasive tests could enable personalised surveillance and potentially increase the interval between more burdensome procedures, while maintaining a high level of medical safety.",[663],"Lynch Syndrome",[665,666],"Lynch Syndrome, hereditary cancer, MMR deficiency, Liquid biopsies, cancer early detection.","Lynch Syndrome, MMR deficiency, Liquid biopsies","NOT_YET_RECRUITING","2026-07-31",{"date":670,"type":40},"2026-08-03",{"date":672,"type":22},"2026-12-01",{"date":674,"type":22},"2030-12-01",{"name":676,"class":453},"UNICANCER",9,""]