[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Hungary\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":660},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,557,0,25,[9,39,73,98,126,153,177,205,247,283,311,332,348,372,398,421,444,471,492,513,536,565,591,613,633],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100639662","a-study-to-identify-and-characterize-patients-with-type-2-diabetes-mellitus-for-possible-participation-in-ongoing-or-future-type-2-diabetes-mellitus-clinical-studies-100639662",false,"NCT07606066","A Study to Identify and Characterize Patients With Type 2 Diabetes Mellitus for Possible Participation in Ongoing or Future Type 2 Diabetes Mellitus Clinical Studies","Inclusion Criteria:\n\n* Participants must be ≥ 18 years of age at the time of signing the ICF.\n* Patients with a diagnosis of T2DM, test- or documentation-confirmed as per World\n\nHealth Organization or local diagnostic standards, inadequately managed with:\n\n1. Lifestyle management alone, AND\u002FOR\n2. A stable dose of background glucose-lowering medication(s) for T2DM (As specified in the Protocol) for at least 45 days prior to signing the ICF.\n\n   * Expresses interest in participating in an ongoing or future T2DM clinical study, is motivated and willing to make themselves available for the duration of the study, and is able to follow study procedures as required.\n   * Provision of signed and dated written informed consent (As specified in the Protocol) before any study-specific procedures, sampling, or analysis.\n\nExclusion Criteria:\n\n* Current or planned use of GLP-1 RAs prohibited in ongoing or future T2DM studies evaluating the efficacy and safety of investigational GLP-1 RAs (As specified in the Protocol).\n* Diagnosed with Type 1 diabetes mellitus.\n* Known pregnancy at the time of visit or having the intention to become pregnant.","ALL","18 Years",{"count":19,"type":20},2150,"ESTIMATED","1 Day","OBSERVATIONAL","The purpose of this study is to identify and characterize patients with known Type 2 Diabetes Mellitus (T2DM) for possible participation in ongoing or future T2DM clinical studies, and to characterize trends in key concomitant medication use in this patient population across different geographical regions.",[25],"Type 2 Diabetes","RECRUITING","2026-08-24",{"date":29,"type":30},"2026-08-25","ACTUAL",{"date":32,"type":30},"2026-05-06",{"date":34,"type":20},"2027-03-31",{"name":36,"class":37},"AstraZeneca","INDUSTRY",76,{"id":40,"slug":41,"hasResults":12,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100597842","a-study-to-compare-the-combination-of-navlimetostat-bms-986504-with-pembrolizumab-and-chemotherapy-versus-placebo-plus-pembrolizumab-and-chemotherapy-in-first-line-metastatic-non-small-cell-lung-cancer-participants-with-homozygous-mtap-deletion-100597842","NCT07063745","A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","A Randomized Phase 2\u002F3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","MountainTAP-29","Inclusion Criteria\n\n* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.\n* Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Participants must have at least 1 measurable lesion as per RECIST v1.1.\n\nExclusion Criteria\n\n* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.\n* Participants must not have symptomatic brain metastases or spinal cord compression.\n* Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).\n\nNote: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.\n\n* Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":48,"type":20},590,"INTERVENTIONAL",[51,52],"PHASE2","PHASE3","The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion",[55],"Metastatic Non-small Cell Lung Cancer With MTAP Deletion",[57,58,59,60,61,62,63,64],"PRMT5","Lung cancer","NSCLC","MTAP","CDKN2A","MRTX1719","First-line","Navlimetostat",{"date":29,"type":30},{"date":67,"type":30},"2026-01-02",{"date":69,"type":20},"2031-08-12",{"name":71,"class":37},"Bristol-Myers Squibb",320,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":49,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100587506","phase-3-a-study-to-assess-the-long-term-safety-of-karxt-for-the-treatment-of-manic-episodes-in-bipolar-i-disorder-balsam-3-100587506","NCT06929273","A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)","A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)","Inclusion Criteria:\n\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  a. Participants must have completed treatment period of parent study.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania.\n  2. Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.\n  3. Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.\n  4. Participants does not require hospitalization for acute mania.\n\nExclusion Criteria:\n\n* All participants:\n\n  1\\. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS.\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  1\\. Discontinuation from any KarXT parent studies.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).\n  2. Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.\n  3. Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test.\n  4. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.\n  5. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","65 Years",{"count":82,"type":20},450,[52],"This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)\n\nThe primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.",[86],"Bipolar Disorder Type I With Mania",[88,89,90],"Bipolar-I disorder","Mania","Bipolar-I disorder with Mania",{"date":29,"type":30},{"date":93,"type":30},"2025-07-18",{"date":95,"type":20},"2028-06-13",{"name":71,"class":37},174,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":49,"phases":108,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100572003","phase-2-a-study-to-assess-the-efficacy-safety-and-tolerability-of-imvt-1402-as-treatment-for-adult-participants-with-graves-disease-100572003","NCT06727604","A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease","A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease","Inclusion Criteria:\n\n* Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.\n* Male or female participants aged ≥ 18 years.\n* Participants with diagnosis of GD who are hyperthyroid despite ATD treatment.\n* Other, more specific inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.\n* Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.\n* Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and\u002For are planning corrective surgery\u002Firradiation or medical therapy for TED during study participation.\n* Additional exclusion criteria are defined in the protocol.","75 Years",{"count":107,"type":20},240,[51],"This is a study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.\n\nThe primary objective of this study is to evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (total triiodothyronine \\[T3\\] or free triiodothyronine \\[FT3\\]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26.",[111],"Graves' Disease",[113,114,115,116,117],"IMVT-1402","Anti Thyroid Drug","Hyperthyroidism","Autoimmune thyroid disease","Imeroprubart",{"date":29,"type":30},{"date":120,"type":30},"2024-12-17",{"date":122,"type":20},"2028-06",{"name":124,"class":37},"Immunovant Sciences GmbH",134,{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":16,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":49,"phases":138,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100557714","phase-3-a-study-investigating-subcutaneously-administered-pozelimab-in-combination-with-cemdisiran-or-cemdisiran-alone-in-adult-participants-with-geographic-atrophy-100557714","NCT06541704","A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy","A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration","SIENNA","Key Inclusion Criteria:\n\n1. Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol\n2. Total GA area in the study eye measuring between ≥2.5 mm\\^2 and ≤17.5 mm\\^2 as described in the protocol\n3. BCVA of 55 letters or better using ETDRS charts (20\u002F80 Snellen equivalent) in the study eye as described in the protocol\n4. Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol\n5. Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol\n\nKey Exclusion Criteria:\n\n1. GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy\n2. History or current evidence of Macular Neovascularization (MNV) and\u002For exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol\n3. Prior or current Intravitreal (IVT) treatment of any kind for any indication in study eye or fellow eye, except approved or investigational IVT complement inhibitor therapy or anti-VEGF therapy, as long as last dose was ≥6 months prior to randomization\n4. Prior intraocular surgery except cataract extraction or minimally invasive glaucoma surgery in study eye as long as date of these procedures was ≥3 months prior to randomization\n5. Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema, uncontrolled glaucoma, full thickness macular hole) in study eye that could affect central vision and confound study\n6. Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination of the study eye (e.g., advanced cataract or corneal abnormalities) as described in the protocol\n\n   Systemic Exclusion criteria\n7. History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol\n8. History of solid organ or bone marrow transplantation\n9. Use of chronic (\\>14 days) systemic corticosteroids (oral or parenteral, ≥20 mg oral prednisone or equivalent) within the previous 30 days prior to the first screening visit as described in the protocol\n10. Current or prior use of systemic immunosuppressive therapy other than corticosteroids within 12 months prior to randomization or the likelihood of treatment with any such agent during the study inclusive of the screening period as described in the protocol\n11. Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol\n12. Carrier of Neisseria meningitidis based on culture collected during screening\n13. Has a hemoglobin A1C ≥ 8.0% during screening as described in the protocol\n\nNOTE: Other protocol-defined Inclusion\u002F Exclusion Criteria apply","50 Years","85 Years",{"count":137,"type":20},975,[52],"This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision (what one sees straight ahead).\n\nThe purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug(s)\n* How much study drug(s) are in the blood at different times\n* Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)",[141,142],"Age-related Macular Degeneration (AMD)","Geographic Atrophy (GA)",[144],"GA secondary to AMD",{"date":29,"type":30},{"date":147,"type":30},"2024-10-30",{"date":149,"type":20},"2033-04-09",{"name":151,"class":37},"Regeneron Pharmaceuticals",224,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":49,"phases":162,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"100520674","bradycardia-pacemaker-with-av-interval-modulation-for-blood-pressure-treatment-100520674","NCT06059638","BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT","BACKBEAT","Inclusion Criteria:\n\n1. Patient has or is indicated for a dual-chamber pacemaker. Visit 1 can be performed within 30 days prior to a planned implant of a Medtronic Astra\u002FAzure dual-chamber pacemaker system or at any time thereafter\n2. On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug\n3. Office SBP ≥135 mmHg and \\\u003C180 mmHg\n4. Average 24-Hour aSBP ≥130 mmHg and \\\u003C170 mmHg\n\nExclusion Criteria:\n\n1. LVEF \\\u003C50%\n2. NYHA Class III-IV\n3. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months\n4. Myocardial infarction (MI) within 3 months\n5. Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months\n6. Permanent atrial fibrillation\n7. Mitral valve regurgitation greater than or equal to grade 3\n8. Aortic stenosis with a valve area less than 1.5 cm2\n9. Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)\n10. Has an existing active cardiac device or neurostimulator other than the recent Astra\u002FAzure pacemaker implant",{"count":161,"type":20},500,[163],"NA","A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra\u002FAzure pacemaker.",[166,167,168],"Hypertension","Hypertension, Systolic","Hypertension, Essential",{"date":29,"type":30},{"date":171,"type":30},"2023-12-27",{"date":173,"type":20},"2029-08",{"name":175,"class":37},"Orchestra BioMed, Inc",130,{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":49,"phases":186,"briefSummary":187,"conditions":188,"keywords":191,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":204},"100409600","phase-2-phase-2-trial-of-adagrasib-monotherapy-and-in-combination-with-pembrolizumab-and-a-phase-3-trial-of-adagrasib-in-combination-in-patients-with-a-kras-g12c-mutation-krystal-7-100409600","NCT04613596","Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7","A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","Inclusion Criteria:\n\n* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS\n* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\\>=50%\n* Phase 3: Presence of measurable disease per RECIST1.1\n* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:\n\n  1. No evidence of brain metastases\n  2. Untreated brain metastases not needing immediate local therapy\n  3. Previously treated brain metastases not needing immediate local therapy\n\nExclusion Criteria:\n\n* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).\n* Phase 2: Active brain metastases\n* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:\n\n  1. Any untreated brain lesions \\> 2.0 cm in size\n  2. Any brainstem lesions\n  3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \\> 10 mg of prednisone (or equivalent) prior to randomization.\n  4. Have poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy\n* Phase 3: Radiation to the lung \\> 30 Gy within 6 months prior to the first dose of study treatment",{"count":185,"type":20},626,[51,52],"The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.\n\nThe Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \\>=50% and who are candidates for first line treatment.",[189,190],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[192,193,59,190,194,195,196],"KRAS G12C","Non-small cell lung cancer","Adagrasib","Krazati","TPS",{"date":29,"type":30},{"date":199,"type":30},"2020-12-02",{"date":201,"type":20},"2029-10-31",{"name":203,"class":37},"Mirati Therapeutics Inc.",770,{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":49,"phases":215,"briefSummary":217,"conditions":218,"keywords":224,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":246},"100311904","phase-4-dabrafenib-andor-trametinib-rollover-study-100311904","NCT03340506","Dabrafenib and\u002For Trametinib Rollover Study","Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and\u002For Trametinib Study","Inclusion Criteria:\n\n* Patient is currently receiving treatment with dabrafenib\u002Ftrametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.\n* In the opinion of the Investigator would benefit from continued treatment.\n\nExclusion Criteria:\n\n* Patient has been previously permanently discontinued from study treatment in the parent protocol.\n* Patient's indication is commercially available and reimbursed in the local country.\n* Patient currently has unresolved toxicities for which dabrafenib and\u002For trametinib dosing has been interrupted in the parent study.","100 Years",{"count":214,"type":20},100,[216],"PHASE4","This study is to provide access for patients who are receiving treatment with dabrafenib and\u002For trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.",[219,220,221,222,223],"Melanoma","Non Small Cell Lung Cancer","Solid Tumor","Rare Cancers","High Grade Glioma",[225,226,227,228,229,219,230,231,232,233,234,220,235,236,237,238,223],"Tafinlar","Mekinist","Dabrafenib","Trametinib","Adult","Melanoma Stage IV","Metastatic Melanoma","Advanced Melanoma","Lung Cancer","NSLC","BRAF V600 Mutation","BRAF Gene Mutation","Solid tumor","Rare cancers",{"date":29,"type":30},{"date":241,"type":30},"2018-01-26",{"date":243,"type":20},"2032-12-28",{"name":245,"class":37},"Novartis Pharmaceuticals",33,{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":257,"conditions":258,"keywords":263,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":282},"100652986","critical-hyperacute-assessment-research-on-neurobiomarker-kinetics-in-acute-brain-injury-100652986","NCT07782216","Critical Hyperacute Assessment Research On Neurobiomarker Kinetics in Acute Brain Injury","Investigating the Significance of Protein Biomarkers During the Hyperacute Phase of Traumatic Brain Injury and Other CNS Conditions With Hypoxia\u002FHypoperfusion in Emergency and Prehospital Settings (CHARON)","CHARON","Inclusion Criteria\n\n* Age 18 years or older (all arms)\n* Polytraumatized patients categorized as T1 triage by the first responder based on injury mechanism and\u002For sustained injuries, with intubation indicated by the first responder (Arm 1)\n* Cardiac arrest treated in the prehospital setting (Arm 2)\n* Severe traumatic brain injury enrolled at hospital admission (Arm 3)\n\nExclusion Criteria (all arms)\n\n* Age under 18 years\n* Pre-existing neurological or psychiatric conditions\n* Hypothermia or hyperthermia at the time of enrollment\n* Pregnancy",{"count":256,"type":20},477,"Traumatic brain injury (TBI) and other conditions that reduce blood flow to the brain - such as cardiac arrest (CA) - are life-threatening medical emergencies. When brain cells are damaged, they release specific proteins into the bloodstream. These proteins, called neurobiomarkers, can be measured in blood samples and may help doctors assess the severity of brain injury, guide treatment, and predict patient outcomes.\n\nA major gap in current knowledge is how these neurobiomarkers behave during the very first minutes and hours after injury - the so-called \"hyperacute\" phase - especially when patients are still being treated by paramedics or have just arrived at the emergency department (ED). It is not yet clear whether biomarker levels rise immediately at the moment of injury or gradually over time, and how quickly they can be reliably detected.\n\nThe CHARON study investigates the time-dependent kinetics of key neurobiomarkers - including S100B, glial fibrillary acidic protein (GFAP), neuron-specific enolase (NSE), ubiquitin carboxy-terminal hydrolase L1 (UCH-L1), neurofilament light chain (NFL), and Tau proteins- during the hyperacute phase of acute brain injury. In addition to these proteins, microRNAs, polar metabolites, and lipid metabolites are also examined as potential biomarkers.\n\nThe study enrolls three groups of participants:\n\n* Patients with severe traumatic brain injury and\u002For polytrauma treated in the prehospital setting and admitted to the ED with T1 (highest priority) triage classification.\n* Patients with CA treated (resuscitated) in the prehospital setting.\n* Patients with severe traumatic brain injury enrolled at hospital (ED) admission.\n\nSerial blood samples are collected at multiple time points, beginning during prehospital care and continuing through the first 24 hours of hospital admission. No experimental treatments are given - all participants receive standard medical care.\n\nBy analyzing biomarker concentration and kinetics across all three groups and correlating findings with neurological outcome at 30 days, the investigators aim to identify the most clinically effective neurobiomarkers for early diagnosis and prognosis of acute brain injury.\n\nThe study is a prospective multi-center investigation conducted at emergency departments, intensive care units, and ambulance services across Hungary.",[259,260,261,262],"Brain Injuries, Traumatic","Brain Injuries, Acute","Hypoxia, Brain","Cardiac Arrest (CA)",[264,265,266,267,268,269,270,271,272],"Biomarkers","Acute-phase Proteins","Kinetics","Prehospital Emergency Care","Emergency Medicine","Brain Injuries","S100 Calcium Binding Protein beta Subunit","Glial Fibrillary Acidic Protein","Out-of-hospital Heart Arrest","2026-08-21",{"date":27,"type":30},{"date":276,"type":30},"2026-03-01",{"date":278,"type":20},"2028-12-31",{"name":280,"class":281},"University of Pecs","OTHER",4,{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":16,"minAge":291,"maxAge":105,"enrollmentInfo":292,"targetDuration":4,"studyType":49,"phases":294,"briefSummary":295,"conditions":296,"keywords":298,"overallStatus":302,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":303,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":310},"100651359","phase-2-a-study-of-brenipatide-ly3537031-in-adult-participants-with-moderate-to-severe-chronic-obstructive-pulmonary-disease-copd-100651359","NCT07759245","A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)","A Phase 2, Multicenter, Randomized, Double-Blind, 52-week Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)","RENEW-COPD","Inclusion Criteria:\n\n* Have a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD), at least 12 months prior to screening who meet the following criteria:\n\n  * Current or former smokers with a smoking history of greater than or equal to (≥) 10 pack-years\n  * Moderate-to-severe COPD (post-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)\u002Fforced vital capacity (FVC) less than (\\\u003C) 70 percent (%)\n  * Modified Medical Research Council Dyspnea Scale (mMRC-DS) grade ≥2\n  * Exacerbation history of ≥2 moderate or ≥1 severe exacerbations within the year prior to inclusion.\n  * Background double therapy \\[long-acting β₂-agonists (LABA) + long-acting muscarinic antagonists (LAMA)\\] or triple therapy \\[inhaled corticosteroids (ICS) + LABA + LAMA)\\] for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to screening.\n\nExclusion Criteria:\n\n* Have a known pre-existing, clinically important lung condition other than COPD.\n* Have a current or recent acute, active infection before screening and up to randomization.","40 Years",{"count":293,"type":20},606,[51],"The main purpose of this study is to assess if different dose levels of Brenipatide are safe and work the way they are intended to work in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), when compared with placebo. The study will last approximately one year.",[297],"Pulmonary Disease, Chronic Obstructive",[299,300,301],"Emphysema","Chronic Bronchitis","Lung Disease","NOT_YET_RECRUITING",{"date":27,"type":30},{"date":305,"type":20},"2026-08",{"date":307,"type":20},"2028-11",{"name":309,"class":37},"Eli Lilly and Company",128,{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":318,"enrollmentInfo":319,"targetDuration":4,"studyType":49,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":325,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":331},"100630086","phase-2-a-study-of-ly4395089-and-mirikizumab-ly3074828-given-together-and-mirikizumab-alone-in-adults-with-crohns-disease-100630086","NCT07483099","A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease","A Phase 2, Multicenter, Randomized, Open-Label, Active-Controlled Study to Investigate LY4395089\u002FMirikizumab Co-administration Compared With Mirikizumab in Adults With Moderately to Severely Active Crohn's Disease","Inclusion Criteria:\n\nParticipants must meet all the inclusion criteria in the IIBD master protocol, except the UC-specific criteria. In addition, they must meet the criteria below:\n\n* Participants taking glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), GLP-1\u002Fglucose-dependent insulinotropic polypeptide (GIP) RAs, GLP-1\u002Fglucagon (Gcg) RAs, GLP-1\u002FGIP\u002FGcg RAs, or similar medications for approved indications will be permitted to enroll provided they are on a stable dose at the time of screening\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the exclusion criteria in the IIBD master protocol, except the UC-specific criteria apply, or if any of the following criteria apply:\n\n* Must not have a hepatic disease\n* Must not have a history of any other bone disease that affects bone metabolism\n* Must not have had any of the following within the past 180 days before screening:\n\n  * acute myocardial infarction\n  * cerebrovascular incident\n  * hospitalization for unstable angina\n  * hospitalization due to congestive heart failure, or\n  * coronary revascularization\n* Must not have received or will need any other prohibited medications as specified in the protocol","80 Years",{"count":320,"type":20},60,[51],"The main purpose of this study is to see how the safety and efficacy of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely active Crohn's disease (CD). This study is part of the IIBD master protocol and will last approximately 62 weeks.",[324],"Crohn Disease",{"date":27,"type":30},{"date":327,"type":30},"2026-05-04",{"date":329,"type":20},"2028-03",{"name":309,"class":37},70,{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":318,"enrollmentInfo":339,"targetDuration":4,"studyType":49,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":346,"leadSponsor":347,"locationsCount":331},"100630084","phase-2-a-master-protocol-iibd-a-study-of-multiple-drugs-in-adults-with-ulcerative-colitis-or-crohns-disease-100630084","NCT07483073","A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease","A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Interventions for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease","Inclusion Criteria:\n\n* Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports a diagnosis of UC or CD.\n* For UC:\n\n  * Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to (≥) 2, confirmed by the central reader and rectal bleeding (RB)≥1, with endoscopy performed within 21 days prior to Visit 2.\n* For CD:\n\n  * Have moderately to severely active CD as defined by a Crohn's disease activity index (CDAI) score ≥ 220 and less than or equal to (≤) 450. Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease within 21 days before the randomization\n* Must have demonstrated an inadequate response, loss of response, or intolerance to at least one of the following: corticosteroids, immunomodulators, or an advanced therapy for UC or CD\n* Have screening laboratory test results within the protocol specified parameters.\n\nExclusion Criteria:\n\n* Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis\n\n  * For UC - must not have a current diagnosis of CD\n  * For CD - must not have a current diagnosis of UC\n* Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol\n* Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndrome\n* Must not have a significant uncontrolled illness that in the opinion of the investigator may compromise the participant's safety or interfere with interpretation of data\n* Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of action\n* Must not have failed an anti-interleukin-23p19 (anti-IL-23p19) antibody treatment\n* Must not have received or will need any prohibited medications for UC or CD as specified in the protocol",{"count":320,"type":20},[51],"Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.",[343,324],"Colitis, Ulcerative",{"date":27,"type":30},{"date":327,"type":30},{"date":329,"type":20},{"name":309,"class":37},{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":16,"minAge":355,"maxAge":356,"enrollmentInfo":357,"targetDuration":4,"studyType":49,"phases":359,"briefSummary":360,"conditions":361,"keywords":363,"overallStatus":302,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":371},"100614915","phase-3-a-study-of-karxt--karx-ec-for-treatment-of-irritability-in-children-and-adolescents-with-autism-spectrum-disorder-100614915","NCT07285798","A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder","Inclusion Criteria\n\n* Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.\n* Participants must have an ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).\n\nExclusion Criteria\n\n* Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).\n* Exception Include: Participants with comorbid ADHD, provided that attention deficit\u002Fhyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.\n* Participants must not have history\u002Fpresence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.\n* Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.\n* Other protocol-defined Inclusion\u002FExclusion criteria may apply.","5 Years","17 Years",{"count":358,"type":20},176,[52],"The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.",[362],"Irritability Associated With Autism Spectrum Disorder",[364],"Autism Spectrum Disorder",{"date":27,"type":30},{"date":367,"type":20},"2026-09-11",{"date":369,"type":20},"2029-08-06",{"name":71,"class":37},63,{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":16,"minAge":134,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":49,"phases":381,"briefSummary":382,"conditions":383,"keywords":386,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":397},"100611500","phase-3-a-study-of-orforglipron-ly3502970-on-cardiovascular-outcomes-in-adults-with-atherosclerotic-cardiovascular-disease-andor-chronic-kidney-disease-attain-outcomes-100611500","NCT07241390","A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease (ATTAIN-Outcomes)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease","Inclusion Criteria:\n\n* Have established ASCVD and\u002For CKD\n\nExclusion Criteria:\n\n* Have type 1 diabetes\n* Have had a major heart condition within 60 days prior to screening\n* Have New York Heart Association Functional Classification Class IV heart failure",{"count":380,"type":20},7140,[52],"The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and\u002For chronic kidney disease (CKD). Participation in the study will last about 5 years.",[384,385],"Atherosclerosis Cardiovascular Disease","Chronic Kidney Disease",[387,388,389,390],"Heart Disease","Kidney Disease","Outcomes","Stroke",{"date":27,"type":30},{"date":393,"type":30},"2025-12-01",{"date":395,"type":20},"2031-08",{"name":309,"class":37},567,{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":105,"enrollmentInfo":406,"targetDuration":4,"studyType":49,"phases":408,"briefSummary":409,"conditions":410,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":418,"locationsCount":420},"100593896","phase-2-a-study-of-long-acting-antibodies-alone-and-in-combinations-for-moderate-to-severe-ulcerative-colitis-100593896","NCT07012395","A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis","Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis","SKYLINE-UC","Inclusion Criteria:\n\n* Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening\n* Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)\n* Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2\n\nExclusion Criteria:\n\n* Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined\n* Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and\u002For other conditions that will likely require surgery during induction\n* Failed 4 or more approved or investigational advanced therapy classes",{"count":407,"type":20},645,[51],"This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.",[411,412,413,343],"Ulcerative Colitis","Inflammatory Bowel Diseases","Colitis",{"date":29,"type":30},{"date":416,"type":30},"2025-05-27",{"date":329,"type":20},{"name":419,"class":37},"Spyre Therapeutics, Inc.",267,{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":49,"phases":431,"briefSummary":432,"conditions":433,"keywords":435,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":437,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":443},"100592970","phase-3-a-phase-iii-study-of-azd0780-on-major-adverse-cv-events-in-patients-with-a-history-of-ascvd-events-or-at-high-risk-for-a-first-event-100592970","NCT07000357","A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event","A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event","AZURE-Outcomes","Inclusion Criteria:\n\n* Meets one of the following:\n\n  1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening\n\n     Additional risk factors based on the level of the LDL-C and timing of MI or stroke:\n\n     o Participants with an LDL-C ≥ 75 mg\u002FdL (≥ 1.9 mmol\u002FL) need to have at least one of the other additional risk factors (i to viii) below.\n\n     ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD\n  2. Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg\u002FdL (≥ 2.6 mmol\u002FL), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii):\n\n  (i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases:\n  1. Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin\u002Fcreatinine ratio ≥ 30 mg\u002Fg) and\u002For persistent eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening\n  2. Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist\n  3. Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist\n  4. ABI \\\u003C 0.9 or \\> 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance\n\n     For (ii) and (iii), participants need to have at least one of the additional risk factors below:\n\n  \u003C!-- -->\n\n  1. CKD with eGFR x mL\u002Fmin\u002F1.73 m2\n  2. Current tobacco use\n  3. Age ≥ 65\n  4. T2DM (if included on the less significant atherosclerosis criterion iii)\n* Participants should receive a background lipid lowering regimen anticipated to achieve at least a \\~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and\u002For bempedoic acid).\n\nParticipants must achieve a stable background lipid lowering therapy \\> 28 days before screening.\n\nExclusion criteria:\n\n* Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.\n* Any revascularisation procedure planned within the next 3 months.\n* Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.\n* Calculated eGFR \\\u003C 15 mL \u002Fmin\u002F1.73 m2 at screening.\n* Any laboratory values with the following deviations at screening:\n\n  * AST or ALT \\> 3 × ULN\n  * TBL \\> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \\\u003C 1.5 × ULN)\n  * Fasting triglycerides ≥ 400 mg\u002FdL (≥ 4.52 mmol\u002FL).\n  * Creatine kinase \\> 5 × ULN\n  * Urine albumin\u002Fcreatinine ratio ≥ 500 mg\u002Fg\n* Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.\n* Inadequately treated hypothyroidism defined as TSH \\> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.\n* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.\n* Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.\n* Use of PCSK9 inhibitors: evolocumab\u002Falirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.",{"count":430,"type":20},15100,[52],"The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.",[434],"Cardiovascular Disease",[436],"Atherosclerotic Cardiovascular Disease",{"date":27,"type":30},{"date":439,"type":30},"2025-06-04",{"date":441,"type":20},"2029-10-26",{"name":36,"class":37},1452,{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":49,"phases":454,"briefSummary":455,"conditions":456,"keywords":458,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":463,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":470},"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":453,"type":20},119,[52],"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.",[457],"Acromegaly",[459,460,461,462],"IGF-1","Growth hormone","Pituitary gland","Gigantism",{"date":27,"type":30},{"date":465,"type":30},"2025-11-26",{"date":467,"type":20},"2029-03",{"name":469,"class":37},"Debiopharm International SA",73,{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":477,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":49,"phases":481,"briefSummary":482,"conditions":483,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":491},"100584534","phase-3-study-of-olomorasib-ly3537982-in-combination-with-standard-of-care-in-participants-with-resected-or-unresectable-kras-g12c-mutant-non-small-cell-lung-cancer-100584534","NCT06890598","Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer","A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02","SUNRAY-02","Inclusion Criteria:\n\n* Histological or cytological confirmation of NSCLC.\n\n  * Part A\n\n    1. Clinical Stage II-IIIB (N0, N1, N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.\n    2. Pathologic Stage II-IIIB (N0, N1, N2) NSCLC treated with initial upfront resection.\n  * Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy.\n* Must have disease with evidence of KRAS G12C mutation.\n* Must have known programmed death-ligand 1 (PD-L1) expression\n* Must have an ECOG performance status of 0 or 1.\n* Able to swallow oral medication.\n* Must have adequate laboratory parameters.\n* Contraceptive use should be consistent with local regulations for those participating in clinical studies.\n* Women of childbearing potential must\n\n  * Have a negative pregnancy test.\n  * Not be breastfeeding during treatment\n\nExclusion Criteria:\n\n* Have known, actionable changes in the EGFR or ALK genes.\n* Have another type of cancer that is progressing or required active treatment within the past 2 years before screening.\n* Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.\n* Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.",{"count":480,"type":20},700,[52],"The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.",[484],"Carcinoma, Non-Small-Cell Lung",{"date":27,"type":30},{"date":487,"type":30},"2025-03-27",{"date":489,"type":20},"2032-02",{"name":309,"class":37},369,{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":49,"phases":501,"briefSummary":502,"conditions":503,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":505,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":512},"100576039","phase-2-substudy-01i-a-study-of-investigational-agents-in-participants-with-previously-treated-stage-iv-squamous-non-small-cell-lung-cancer-nsclc-mk-3475-01ikeymaker-u01i-100576039","NCT06780098","Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I\u002FKEYMAKER-U01I)","KEYMAKER-U01 Substudy 01I: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Histologically or cytologically confirmed diagnosis of Stage IV squamous non-small cell lung cancer (NSCLC)\n* Has documented disease progression per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1), as assessed by investigator after receiving an anti-programmed cell death protein 1 (anti-PD-1)\u002Fprogrammed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy for Stage IV disease\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\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\n* Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements\n* Has uncontrolled or significant cardiovascular disorder\n* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc), or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc), or prior pneumonectomy\n* Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline\n* Has clinically significant corneal disease\n* Has previously received docetaxel as monotherapy or in combination with other therapies\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known untreated central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Evidence of any leptomeningeal disease\n* Has one or more of the following indicators of interstitial lung disease (ILD)\u002Fpneumonitis: any history of ILD\u002Fpneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), current diagnosis of ILD, clinical or radiographic suspicion of ILD\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* Active infection requiring systemic therapy\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Known history of, or active, neurologic paraneoplastic syndrome\n* History of allogeneic tissue\u002Fsolid organ transplant\n* Has not adequately recovered from major surgery or have ongoing surgical complications",{"count":500,"type":20},144,[51],"Researchers are looking for other ways to treat metastatic squamous non-small cell lung cancer (NSCLC). Squamous NSCLC is cancer that starts in squamous cells, which are flat cells that line the inside of the airways in the lungs. Metastatic means the cancer has spread to other parts of the body.\n\nStandard treatment (usual treatment) for metastatic squamous NSCLC is immunotherapy with or without chemotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing. However, standard treatment may not work or may stop working to treat metastatic squamous NSCLC.\n\nResearchers want to learn if study treatments that are antibody drug conjugates (ADCs) can treat metastatic squamous NSCLC that did not respond (get smaller or go away) to standard treatment. An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.\n\nThe main goals of this study are to learn about:\n\n* The cancer response to the study treatments compared to chemotherapy\n* The safety of the study treatments and if people tolerate them\n\nThis study is one of the substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01\u002FKEYMAKER-U01).",[504],"Lung Neoplasm",{"date":29,"type":30},{"date":507,"type":30},"2025-05-28",{"date":509,"type":20},"2032-03-02",{"name":511,"class":37},"Merck Sharp & Dohme LLC",44,{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":49,"phases":522,"briefSummary":523,"conditions":524,"keywords":525,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":529,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":535},"100576038","phase-2-a-study-of-investigational-agents-in-participants-with-previously-treated-stage-iv-nonsquamous-non-small-cell-lung-cancer-nsclc-mk-3475-01hkeymaker-u01-100576038","NCT06780085","A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H\u002FKEYMAKER-U01)","KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Histologically or cytologically confirmed diagnosis of Stage IV nonsquamous non-small cell lung cancer (NSCLC)\n* Documented disease progression per RECIST 1.1 after receiving an anti-programmed cell death 1 protein (PD-1)\u002Fprogrammed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy\n* Confirmation per local test report that epidermal growth factor receptor negative (EGFR-), anaplastic lymphoma kinase negative (ALK-), c ros oncogene 1 negative (ROS1-), or other directed therapy is not indicated as primary therapy\n* Measurable disease per RECIST 1.1 as assessed by investigator and verified by BICR\n* Life expectancy of at least 3 months\n* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization\n* Is an individual of any sex\u002Fgender who is at least 18 years of age at the time of providing the informed consent\n* Has adequate organ function\n* If capable of producing sperm refrains from donating sperm plus either abstains from penile-vaginal intercourse or uses a penile\u002Fexternal condom, with contraceptive use consistent with local regulations\n* Participant\u002Fparticipants of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test; and is not breastfeeding and uses a highly effective contraceptive method\n* Archival tumor tissue sample of a tumor lesion not previously irradiated has been provided\n* Has provided tissue prior to treatment randomization from a newly obtained formalin-fixed sample from a new biopsy\n* Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Participants who are hepatitis B surface antigen (HBsAg) positive 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\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements\n* Received radiation therapy to the lung\n* Has uncontrolled or significant cardiovascular disorder prior to randomization\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline\n* Has known severe hypersensitivity (≥Grade 3) to study intervention and\u002For any of its excipients\n* Has clinically significant corneal disease\n* Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids\n* Has inadequate washout period prior to randomization\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy\n* Has previously received docetaxel as monotherapy or in combination with other therapies\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known untreated central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has evidence of any leptomeningeal disease\n* Has history of interstitial lung disease (ILD)\u002Fpneumonitis, current diagnosis of ILD, and\u002For suspected ILD\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has active infection requiring systemic therapy\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease\n* Has known history of, or active, neurologic paraneoplastic syndrome\n* Has history of allogeneic tissue\u002Fsolid organ transplant\n* Have not adequately recovered from major surgery or have ongoing surgical complications",{"count":521,"type":20},96,[51],"Researchers are looking for new ways to treat metastatic nonsquamous non-small cell lung cancer (NSCLC) that has been treated before. Metastatic means the cancer has spread to other parts of the body. Nonsquamous means the cancer did not start in squamous cells, which are flat cells that line the inside of the lungs.\n\nStandard treatment (usual treatment) for NSCLC is surgery, then immunotherapy with or without chemotherapy after surgery. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is a medicine that works to destroy cancer cells or stop them from growing.\n\nHowever, standard treatment may not work or may stop working for some people. Researchers want to know if 2 antibody drug conjugates (ADCs) can help treat metastatic nonsquamous NSCLC that did not respond (get smaller or go away) to treatment. An ADC attaches to specific targets on cancers cells and delivers treatment to destroy those cells.\n\nResearchers will compare 2 different ADCs (the study treatments) to chemotherapy in this study. The goals of this study are to learn:\n\n* About the safety of the study treatments and if people tolerate them\n* How many people have the cancer respond to the study treatments",[484],[526,527,528],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Death-Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)",{"date":29,"type":30},{"date":531,"type":30},"2025-05-13",{"date":533,"type":20},"2032-03-12",{"name":511,"class":37},34,{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":49,"phases":545,"briefSummary":546,"conditions":547,"keywords":550,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":557,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":564},"100574886","phase-3-neladalkib-nvl-655-for-tki-naive-patients-with-advanced-alk-positive-nsclc-100574886","NCT06765109","Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC","A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)","ALKAZAR","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)\n2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood\n3. No prior systemic anticancer treatment for NSCLC (adjuvant\u002Fneoadjuvant chemotherapy allowed if 12 months prior to randomization; prior ALK tyrosine kinase inhibitor \\[TKI\\] such as alectinib is not allowed in any setting)\n4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1)\n5. Pretreatment tumor tissue\n\nExclusion Criteria:\n\n1. Patient's cancer has a known oncogenic driver alteration other than ALK.\n2. Known allergy\u002Fhypersensitivity to excipients of neladalkib or alectinib.\n3. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization\n4. Major surgery within 4 weeks prior to randomization\n5. Uncontrolled clinically relevant infection requiring systemic therapy\n6. Known active tuberculosis, or active Hepatitis B or C\n7. QT corrected for heart rate by Fridericia's formula (QTcF) \\> 470 msec on repeated assessments\n8. Clinically significant cardiovascular disease\n9. Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease\n10. Active malignancy requiring therapy within 2 years prior to randomization",{"count":82,"type":20},[52],"Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).",[548,549],"Non-small Cell Lung Cancer","Anaplastic Lymphoma Kinase-positive",[59,58,551,552,553,554,555,556],"Lung neoplasms","Lung diseases","ALK positive NSCLC","TKI naive","ALK TKI naive","Treatment naive",{"date":29,"type":30},{"date":559,"type":30},"2025-07-17",{"date":561,"type":20},"2029-12",{"name":563,"class":37},"Nuvalent Inc.",158,{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":571,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":212,"enrollmentInfo":573,"targetDuration":4,"studyType":49,"phases":575,"briefSummary":576,"conditions":577,"keywords":579,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":590},"100570795","phase-3-phase-iii-extension-study-of-efficacy-and-safety-of-ianalumab-with-or-without-study-treatment-withdrawal-in-participants-with-lupus-nephritis-sirius-ln-extension-100570795","NCT06711887","Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)","An Open-label Extension Study to Assess the Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Adult Participants With Lupus Nephritis Who Have Completed Study Treatment in the CVAY736K12301 Core Study (SIRIUS-LN Extension)","SIRIUS-LN ext","Inclusion Criteria:\n\n1. Signed informed consent prior to participation in the extension study.\n2. Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment.\n\nExclusion Criteria:\n\n1. Use of prohibited therapies\n2. Pregnant or nursing (lactating) women.",{"count":574,"type":20},348,[52],"The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety\n\n1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \\[CRR\\] or partial renal response \\[PRR\\]) on double-blind treatment at the end of the SIRIUS-LN core study, and\n2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR\u002FPRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.",[578],"Lupus Nephritis",[580,581,582,583],"Lupus Nephritis (LN)","B cell depletion","ianalumab","VAY736",{"date":27,"type":30},{"date":586,"type":30},"2025-05-19",{"date":588,"type":20},"2035-08-01",{"name":245,"class":37},47,{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":598,"targetDuration":4,"studyType":49,"phases":600,"briefSummary":601,"conditions":602,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":605,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":612},"100569788","phase-3-a-study-to-understand-how-the-study-medicine-dazukibart-works-in-people-with-idiopathic-inflammatory-myopathies-100569788","NCT06698796","A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies","A PHASE 3, MULTI-CENTER, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF DAZUKIBART IN PARTICIPANTS WITH IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH DERMATOMYOSITIS OR POLYMYOSITIS)","Inclusion Criteria:\n\n* Participants that completed a qualifying study through Week 52.\n\nExclusion Criteria:\n\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation.\n* Previous administration with an investigational product (drug or vaccine) other than dazukibart in a qualifying study within 30 days (or as determined by the local requirement) or 5 half-lives preceding baseline in this study (whichever is longer).\n* Current use of any prohibited concomitant medication(s).\n* Active bacterial, viral, fungal, mycobacterial or other infections.\n* Ongoing adverse event in a qualifying study or the participant has met safety monitoring criteria in a qualifying study that have not resolved.\n* Investigator site staff or sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.",{"count":599,"type":20},211,[52],"The purpose of this study is to understand how the study medicine, dazukibart, works in people with active idiopathic inflammatory myopathies (dermatomyositis \\[DM\\] or polymyositis \\[PM\\]).\n\nIdiopathic inflammatory myopathies are a group of disorders that show inflammation of the muscles used for movement. There are several types of idiopathic inflammatory myopathies, including DM and PM.\n\nDM and PM involve weakness of the muscles closest to the center of the body, such as the muscles of the hips, thighs, upper arms, and neck. People with these forms of idiopathic inflammatory myopathies may find it difficult to climb stairs, get up from a seated position, or lift items above their head. People with DM can also have a skin rash.\n\nThese disorders negatively impact the quality of life and functioning of patients. In addition to the above, these disorders can affect how the lungs and heart work.\n\nThis study is seeking participants who took part in a DM and PM study with dazukibart before. Some participants will receive study medicine, and some participants will not receive study medicine and only complete safety follow-up.\n\nThe study medicine will be given as an intravenous (IV) infusion (directly into the veins). This takes about 1 hour, every 4 weeks, from Day 1 to Week 48 (about 12 months) of the study. This will be followed by a safety follow-up period that lasts about 4 months after the last infusion. Participants who receive study medicine will have about 18 study visits at the site over about 16 months.\n\nThere will also be participants enrolled in this study who will not receive study medicine. Such participants will only take part in safety follow-up visits as they do not want to or are not eligible to receive dazukibart. These participants will not receive study medicine and will have up to 4 study visits at the site every 4 weeks to complete safety follow-up.",[603,604],"Dermatomyositis","Polymyositis",{"date":29,"type":30},{"date":607,"type":30},"2025-01-22",{"date":609,"type":20},"2031-07-29",{"name":611,"class":37},"Pfizer",26,{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":4,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":16,"minAge":620,"maxAge":4,"enrollmentInfo":621,"targetDuration":4,"studyType":49,"phases":623,"briefSummary":624,"conditions":625,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":627,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":631,"locationsCount":632},"100542140","phase-3-a-study-of-lebrikizumab-ly3650150-in-participants-with-chronic-rhinosinusitis-and-nasal-polyps-treated-with-intranasal-corticosteroids-contrast-np-100542140","NCT06338995","A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)","A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab\u002FLY3650150 in Participants With Chronic Rhinosinusitis With Nasal Polyps on Background Intranasal Corticosteroids","Inclusion Criteria:\n\n* Physician-diagnosed chronic rhinosinusitis (CRS) with bilateral nasal polyps (NP).\n* Prior treatment with systemic corticosteroids (SCS) within the last 2 years (or a medical contraindication or intolerance to SCS), prior surgery for NP, or both.\n* Endoscopic bilateral NPS score of at least 5 out of 8, with a minimum score of 2 in each nasal cavity performed at screening and baseline.\n* Ongoing symptoms for at least 8 weeks prior to study entry (screening), including:\n\n  1. Nasal congestion with moderate or severe symptom severity (score 2 or 3) at screening and a weekly average severity score of at least 1 (range 0 to 3) at randomization, and\n  2. At least one other symptom, such as partial loss of smell (hyposmia), total loss of smell (anosmia), or anterior or posterior rhinorrhea.\n* Have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.\n* Adolescent participants ≥12 to \\\u003C18 years of age and weighing ≥40 kg at time of Visit 1.\n\nExclusion Criteria:\n\n* Have received a dose of lebrikizumab.\n* Have received treatment with any rescue medication and\u002For have the need for surgery for NP during screening and\u002For run-in period.\n* Allergen immunotherapy (subcutaneous immunotherapy \\[SCIT\\]\u002Fsublingual immunotherapy \\[SLIT\\]) initiated within 6 months prior to screening, that is not on a stable dose (3 months prior to screening).\n* Has received a biologic treatment approved for use in CRSwNP, asthma, or AD, even if administered to treat a different condition, within 4 months or 5 half-lives, whichever is longer, prior to screening.\n* Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit:\n\n  1. B cell-depleting biologics, including rituximab, within 6 months.\n  2. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.\n  3. Systemic immunosuppressants within 4 weeks prior to baseline.\n* Have had any sinus intranasal surgery (including nasal polypectomy) within 6 months prior to screening\n* Have had prior sino-nasal surgery or sinus surgery changing lateral wall structure of the nose making it difficult to assess endoscopic NPS\n* Have a presence of any of the following conditions that may impact the assessment of endpoints at screening or baseline:\n\n  1. Nasal septal deviation occluding at least one nostril.\n  2. Antrochoanal polyps.\n  3. Acute sinusitis, acute nasal infection, or acute upper respiratory infection.\n  4. Ongoing rhinitis medicamentosa.\n  5. Presence of another diagnosis associated with NP (ie, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young's syndrome, primary ciliary dyskinesia, cystic fibrosis). Note: for adolescents, documentation for ruling out cystic fibrosis and primary ciliary dyskinesia is required.\n  6. A nasal cavity tumor (malignant or benign).\n  7. Evidence of fungal rhinosinusitis.\n* Have anosmia from COVID or any reason other than CRSwNP.\n* Participants with forced expiratory volume in 1 second (FEV1) 50% or less (of predicted normal) at screening.\n* Female participant who is pregnant, breastfeeding, or is planning to become pregnant, or to breastfeed during the study.","12 Years",{"count":622,"type":20},510,[52],"The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.",[626],"Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)",{"date":27,"type":30},{"date":629,"type":30},"2024-04-29",{"date":329,"type":20},{"name":309,"class":37},202,{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":638,"acronym":639,"eligibilityCriteria":640,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":105,"enrollmentInfo":641,"targetDuration":4,"studyType":49,"phases":643,"briefSummary":644,"conditions":645,"keywords":647,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":652,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":657,"locationsCount":659},"100526296","phase-2-a-study-to-determine-if-bhv-7000-is-effective-and-safe-in-adults-with-refractory-focal-onset-epilepsy-100526296","NCT06132893","A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy","A Phase 2\u002F3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy","RISE 2","Key Inclusion Criteria:\n\n1. Male and Female participants 18 to 75 years of age at time of consent.\n2. Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.\n\n   a. Focal seizures i. Focal aware seizures with clinically observable signs and\u002For symptoms ii. Focal impaired awareness seizures iii. Focal to bilateral tonic-clonic seizures\n3. Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (ASM) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.\n4. Ability to keep accurate seizure diaries\n5. Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total\n\nKey Exclusion Criteria:\n\n1. History of status epilepticus (convulsive status epilepticus for \\> 5 minutes or focal status epilepticus with impaired consciousness for \\> 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure.\n2. History of repetitive\u002Fcluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.\n3. Resection neurosurgery for seizures \\\u003C4 months prior to the screening visit.\n4. Radiosurgery performed \\\u003C2 years prior to the screening visit.\n5. Subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal EEG correlation with clinical symptoms.\n6. Any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and\u002For confound the interpretation of safety or efficacy data from the study, as judged by the Investigator",{"count":642,"type":20},390,[51,52],"The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.",[646],"Focal Epilepsy",[646,648,649,650,651],"Epilepsy","Seizure","Refractory Epilepsy","Partial Epilepsy",{"date":27,"type":30},{"date":654,"type":30},"2024-03-14",{"date":656,"type":20},"2026-12",{"name":658,"class":37},"Biohaven Therapeutics Ltd.",124,""]