[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Portugal\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":707},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,649,0,25,[9,53,78,111,141,172,194,225,249,270,308,350,374,403,431,458,485,506,529,552,576,597,626,645,680],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100626090","phase-1-a-study-of-air-001-in-adults-with-alpha-1-antitrypsin-deficiency-aatd-100626090",false,"NCT07431112","A Study of AIR-001 in Adults With Alpha-1 Antitrypsin Deficiency (AATD)","Phase 1, Open-Label, Single Ascending Dose and Multiple Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered AIR-001 in Adults With AATD Due to PiZZ Genotype","RepAIR1","Inclusion Criteria:\n\n1. Male or female participants \\>18 years and \\\u003C75 years of age at the time of signing informed consent\n2. Total serum AAT levels \\\u003C 11µM (57 mg\u002FdL)\n3. Pi\\*ZZ genotype confirmed by DNA sequencing within the SERPINA1 gene with no known co-occurring SERPINA1 null variants\n4. Spirometry: Forced expiratory volume in 1 second (FEV1) ≥ 40% of predicted\n5. Non-smoker, including vaping, for at least 6 months prior to screening\n6. Body mass index between 18-33.0 kg\u002Fm²\n7. Body weight ≥ 45 kg and ≤110 kg\n8. Willing and able to give written informed consent prior to the initiation of any study procedure by the participant\n9. Negative beta human chorionic gonadotropin (β-hCG) at enrolment for women of childbearing potential (WOCBP) only.\n10. Participants who are either a WOCBP or male participant who is heterosexually active with a WOCBP must consent to use a highly effective method of contraception from screening visit until at least 4 weeks after the last dose of investigational medicinal product (IMP).\n11. Willing and able to comply with the study design schedule, all study procedures, and other requirements\n\nExclusion Criteria:\n\n1. Female participants who are nursing or lactating\n2. Participant has received AAT augmentation therapy within 30 days prior to Screening Visit or plans to receive AAT augmentation therapy at any time during study participation.\n3. Known or suspected allergy or intolerance to AIR-001 or its components\n4. Acute respiratory tract infection or clinically-diagnosed chronic obstructive pulmonary disease (COPD) exacerbation that required antibiotic treatment and\u002For systemic corticosteroids within the 8 weeks prior to dosing.\n5. Positive screening test for COVID-19 and\u002For Influenza.\n6. Lung disease that requires use of continuous oral corticosteroids, continuous supplemental oxygen, day-time ventilatory support, or any participant who is on a lung transplant waiting list.\n7. Liver Fibrosis score \\> 10 kPa defined by screening liver elastography, historical liver biopsy showing ≥ F3 fibrosis (METAVIR or comparable scoring system), or established diagnosis of hepatic cirrhosis.\n8. Any of the following screening laboratory abnormalities:\n\n   1. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma-glutamyl transferase (GGT) \\> 3 x upper limit of normal (ULN)\n   2. Total bilirubin \\> ULN (note: for participants with documented Gilbert's syndrome and direct bilirubin ≤ ULN , exclusion criterion is total bilirubin is \\> 2.5 mg\u002FdL)\n   3. INR \\> ULN (for participants taking stable doses of anticoagulants, the exclusion criterion is INR \\> 3.0)\n   4. Platelet count ≤ 150 k\u002FμL\n   5. Estimated glomerular filtration rate (eGFR) ≤ 60 mL\u002Fmin\u002F1.73m² by Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation\n   6. Urine Albumin-to-Creatinine Ratio \\> 300 mg\u002Fg\n   7. Urine Protein-to-Creatinine Ratio \\> 500 mg\u002Fg\n9. Prolonged QT interval on electrocardiogram (ECG), defined as QTcF ≥ 450ms (men) or ≥ 470ms (women)\n10. ECG findings at screening that render measurements of QT interval imprecise.\n11. History of congestive heart failure, serious cardiac arrythmias requiring anti-arrhythmic medications or unexplained black-outs or fainting episodes with a suspected cardiac origin\n12. Positive screening test or known chronic infection with Hepatitis B, Hepatitis C, or HIV.\n13. Known history of coagulopathy or bleeding diathesis\n14. History or intolerance to subcutaneous (SC) injection including relevant dermatological conditions affecting standard injection sites\n15. History or presence of any medical condition, behavioral or psychiatric disorder, or planned surgical procedure or surgical history that may interfere with participation in the study or interpretation of study results, and\u002For put the participant at significant risk (in the opinion of the investigator) if he\u002Fshe participates in the study.\n16. History of any lung-volume reduction procedure in the 6 months prior to screening.\n17. Laboratory value(s) outside the laboratory reference range that is (are) considered to be clinically significant and may affect the safety, efficacy, PK, or PD assessments or interpretation by the Investigator, at screening\n18. History of alcohol or drug abuse within the past three months\n19. Current or previous participation in any other clinical study where the participant has received a dose of an IMP within 3 months or 5 half-lives of the IMP, whichever is longest, prior to Screening Visit\n20. Any previous gene replacement or DNA-editing therapy\n21. Any previous use of an RNA-based therapeutic (except for AIR-001 or RNA-based vaccines) within the 6 months prior to the Screening Visit or at any time if stopped due to drug-related adverse event.\n22. Use of any new prescription, vaccine, herbal remedy, over-the-counter medication, or supplement, or changes in chronic therapies within the 28 days prior to dosing unless approved by study Medical Monitor.","ALL","18 Years","74 Years",{"count":22,"type":23},54,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This is a Phase 1, open-label, single ascending dose (SAD) and multiple dose (MD) study of AIR-001 in participants with alpha-1 antitrypsin deficiency (AATD) due to PiZZ genotype.",[29],"Alpha 1 Antitrypsin Deficiency",[31,32,33,34,35,36,37,38,39,29],"Lung Diseases","Liver Diseases","Respiratory Tract Diseases","Genetic Disease","Inborn Congenital, Hereditary, Neonatal Diseases and Abnormalities","Subcutaneous Emphysema","Emphysema","Pathologic Processes","Pathological Conditions, Signs and Symptoms","RECRUITING","2026-08-24",{"date":43,"type":44},"2026-08-25","ACTUAL",{"date":46,"type":44},"2026-03-17",{"date":48,"type":23},"2029-01",{"name":50,"class":51},"AIRNA Corporation","INDUSTRY",8,{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":24,"phases":65,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100610019","phase-3-a-study-of-baricitinib-ly3009104-for-the-delay-of-stage-3-type-1-diabetes-in-at-risk-children-and-adults-100610019","NCT07222137","A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults","A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to \u003C36 Years","BARICADE-DELAY","Inclusion Criteria:\n\n* Have a history of at least one documented occasion of at least two diabetes-related autoantibodies, AND one occasion of at least two diabetes-related autoantibodies obtained at screening or prescreening\n* Have Stage 1b or Stage 2 type 1 diabetes\n* Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening\n\nExclusion Criteria:\n\n* Have any other type of diabetes\n* Have uncontrolled high blood pressure\n* Have had a heart attack, heart disease, stroke, or heart failure\n* Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy\n* Have a current or recent clinically serious infection","1 Year","35 Years",{"count":64,"type":23},150,[66],"PHASE3","The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.",[69],"Diabetes Mellitus, Type 1",{"date":43,"type":44},{"date":72,"type":44},"2026-01-12",{"date":74,"type":23},"2031-07",{"name":76,"class":51},"Eli Lilly and Company",113,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":24,"phases":89,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100502809","phase-3-phase-iiib-study-of-ribociclib--et-in-early-breast-cancer-100502809","NCT05827081","Phase IIIb Study of Ribociclib + ET in Early Breast Cancer","A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)","Adjuvant WIDER","Key Inclusion criteria:\n\n* Participant is an adult, male or female ≥ 18 years of age at the time of informed consent form signature (IC).\n* Participant has a histologically and\u002For cytologically confirmed diagnosis of estrogen-receptor positive and\u002For progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample tested by a local laboratory prior to enrollment.\n* Participant has HER2- BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing based on the most recently analyzed tissue sample.\n* Participants may have already received any standard neoadjuvant and\u002For adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrollment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy.\n* For participants with prior ET treatment \\> 12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrollment.\n* The number of participants with prior ET between 12 and 36 months will be capped at 30%. The cap will not apply to Black or African American participants.\n* Participant has no contraindication to receive adjuvant ET in the study.\n* Participant after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:\n\n  * Anatomic Stage Group III, or\n  * Anatomic Stage Group IIB, or\n  * A subset of Anatomic Stage Group IIA.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.\n* Participant has adequate bone marrow and organ function.\n* ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as:\n\n  * QTcF interval at Screening \\\u003C 450 msec (QT interval using Fridericia's correction).\n  * Mean resting heart rate 50-99 beats per minute (determined from the ECG).\n\nKey Exclusion criteria:\n\n* Participant with distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and\u002For evidence of recurrence after curative surgery.\n* Participant is concurrently using other antineoplastic therapy with the exception of adjuvant ET.\n* Participant has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate participant participation in the clinical study or compromise compliance with the protocol, or limit life expectancy to ≤5 years.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality.\n* Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.\n* Women of child-bearing potential (CBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 21 days after stopping the treatment.\n\nOther inclusion\u002Fexclusion criteria may apply","100 Years",{"count":88,"type":23},1400,[66],"The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).",[92],"Early Breast Cancer",[94,95,96,97,98,99,100,101,102],"Hormone receptor positive (HR+)","Human epidermal growth factor receptor-2 negative (HER2-)","Early breast cancer (EBC)","premenopausal","postmenopausal","male breast cancer","ribociclib","LEE011","Endocrine therapy (ET)",{"date":43,"type":44},{"date":105,"type":44},"2024-02-28",{"date":107,"type":23},"2030-09-20",{"name":109,"class":51},"Novartis Pharmaceuticals",228,{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":24,"phases":120,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"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":119,"type":23},626,[121,66],"PHASE2","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.",[124,125],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[127,128,129,125,130,131,132],"KRAS G12C","Non-small cell lung cancer","NSCLC","Adagrasib","Krazati","TPS",{"date":43,"type":44},{"date":135,"type":44},"2020-12-02",{"date":137,"type":23},"2029-10-31",{"name":139,"class":51},"Mirati Therapeutics Inc.",770,{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":24,"phases":151,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":171},"100610816","early-doppler-assisted-mobilization-in-adults-after-acute-ischemic-stroke-100610816","NCT07232498","Early Doppler-Assisted Mobilization in Adults After Acute Ischemic Stroke","Early Doppler-Assisted Mobilization in Adults After Acute Ischemic Stroke - a Randomized Clinical Trial","DOP-MOBILIZE","Inclusion Criteria:\n\n* Patients diagnosed with ischemic stroke aged 18 years or older;\n* Ability to undergo carotid and transcranial Doppler ultrasound, as well as to mobilize within 48 hours;\n* Informed consent obtained from the patient or legal representative.\n\nExclusion Criteria:\n\n* Pre-existing disability with a modified Rankin Scale (mRS) score ≥ 4;\n* Diagnosis of Transient Ischemic Attack (TIA);\n* Severe hemodynamic instability, defined as:\n* Systolic blood pressure \\\u003C 100 mmHg or \\> 220 mmHg;\n* Peripheral oxygen saturation \\\u003C 92%;\n* Heart rate \\\u003C 40 or \\> 112 beats per minute;\n* Body temperature \\> 38.5°C;\n* Neurological deterioration with altered level of consciousness (defined as Glasgow Coma Scale \\\u003C 10);\n* Patients who underwent neurosurgical intervention within the past 30 days;\n* Concomitant diagnosis of a rapidly progressive fatal disease (e.g., terminal-stage cancer);\n* Requirement for continuous monitoring or continuous intravenous drug infusion;\n* Acute deep vein thrombosis\u002Fpulmonary embolism.",{"count":150,"type":23},1300,[152],"NA","Post-stroke mobilization remains a subject of ongoing debate. While early mobilization-particularly the first out-of-bed mobilization-has been associated with reduced systemic complications and earlier rehabilitation, it also carries potential risks, such as neurological deterioration in the presence of hemodynamic instability.\n\nIn this study, the primary aim is to investigate whether early mobilization, guided by hemodynamic evaluation after acute ischemic stroke offers superior outcomes compared to standard clinical care.",[155],"Arterial Ischemic Stroke",[155,157,158,159,160,161],"Early mobilization","mRS","Transcranial doppler ultrasound","Neurology","Hemodynamics","2026-08-23",{"date":43,"type":44},{"date":165,"type":44},"2025-06-04",{"date":167,"type":23},"2027-12",{"name":169,"class":170},"Unidade Local de Saúde de Coimbra, EPE","OTHER",3,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":24,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},"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":181,"type":23},700,[66],"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.",[185],"Carcinoma, Non-Small-Cell Lung","2026-08-21",{"date":41,"type":44},{"date":189,"type":44},"2025-03-27",{"date":191,"type":23},"2032-02",{"name":76,"class":51},369,{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":24,"phases":204,"briefSummary":205,"conditions":206,"keywords":209,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"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":203,"type":23},450,[66],"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).",[207,208],"Non-small Cell Lung Cancer","Anaplastic Lymphoma Kinase-positive",[129,210,211,212,213,214,215,216],"Lung cancer","Lung neoplasms","Lung diseases","ALK positive NSCLC","TKI naive","ALK TKI naive","Treatment naive",{"date":43,"type":44},{"date":219,"type":44},"2025-07-17",{"date":221,"type":23},"2029-12",{"name":223,"class":51},"Nuvalent Inc.",158,{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":18,"minAge":233,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":24,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":248},"100567773","phase-3-a-platform-trial-for-pediatric-participants-with-obesity-or-overweight-ly900040-100567773","NCT06672549","A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)","A Master Protocol for a Randomized, Controlled, Clinical Platform Trial to Investigate the Efficacy and Safety of Interventions for Chronic Weight Management in Pediatric Participants With Obesity or Overweight","ADVANCE","Inclusion Criteria:\n\n* Have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening.\n* Obesity as defined by BMI equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart \\[CDC-NCHS, 2022\\]); OR\n* Applies to participant age between 12 and \\\u003C18 years old. Overweight as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart (CDC-NCHS, 2022), and at least 1 weight-related comorbidity,\n\n  * hypertension\n  * type 2 diabetes (T2D)\n  * prediabetes\n  * dyslipidemia\n  * obstructive sleep apnea\n  * metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD)\n\nExclusion Criteria:\n\n* Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to:\n\n  * gastric bypass\n  * sleeve gastrectomy\n  * restrictive bariatric surgery, such as Lap-Band® gastric banding, or\n  * any other procedure intended to result in weight reduction.\n* Have a diagnosis that is a secondary cause of obesity or have a history of abrupt onset of obesity suggesting a secondary cause, such as hypothalamic, monogenetic, syndromic, or endocrine causes.\n* Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records\n* Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state.\n* Have HbA1c \\>9.0% (75 mmol\u002Fmol) as measured by central laboratory at screening.\n* Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2.","6 Years","17 Years",{"count":236,"type":23},125,[66],"The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.",[240,241],"Obesity","Overweight",{"date":41,"type":44},{"date":244,"type":44},"2024-11-18",{"date":246,"type":23},"2027-03",{"name":76,"class":51},117,{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":18,"minAge":256,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":24,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":269},"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":258,"type":23},510,[66],"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.",[262],"Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)",{"date":41,"type":44},{"date":265,"type":44},"2024-04-29",{"date":267,"type":23},"2028-03",{"name":76,"class":51},202,{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":24,"phases":279,"briefSummary":280,"conditions":281,"keywords":283,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":307},"100527808","phase-3-magnetismm-32-a-study-to-learn-about-the-study-medicine-called-elranatamab-in-people-with-multiple-myeloma-mm-that-has-come-back-after-taking-other-treatments-including-prior-treatment-with-an-anti-cd38-antibody-and-lenalidomide-100527808","NCT06152575","MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)","A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED\u002FREFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY","Inclusion Criteria:\n\n* Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.\n* Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.\n* Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g\u002FdL; (b) Urinary M-protein excretion ≥200 mg\u002F24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg\u002FdL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\\\u003C0.26 or \\>1.65).\n* Have clinical laboratory values within the specified range.\n* ECOG (Eastern Cooperative Oncology Group) performance status ≤2.\n* Not pregnant or breastfeeding and willing to use contraception.\n\nExclusion Criteria:\n\n* Smoldering multiple myeloma.\n* Plasma cell leukemia.\n* Amyloidosis.\n* Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.\n* Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.\n* Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.\n* Any active, uncontrolled bacterial, fungal, or viral infection.\n* Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)\n* Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.\n* Unable to receive investigator's choice therapy.\n* Live attenuated vaccine within 4 weeks of the first dose of study intervention.\n* Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.",{"count":278,"type":23},492,[66],"The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer).\n\nThis study is seeking participants who:\n\n* Are 18 years of age or older and have MM.\n* Have received treatments before for MM.\n* Have MM that has returned or not responded to their most recent treatment.\n\nHalf of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM.\n\nElranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study.\n\nThe medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as:\n\n* a shot under the skin at the study clinic\n* through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects.\n\nParticipants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits).\n\nThe study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.",[282],"Multiple Myeloma",[284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299],"Elranatamab","B-Cell Maturation Antigen","BCMA","Bispecific antibody","BCMA-CD3 bispecific antibody","Myeloma","Multiple myeloma","Relapsed multiple myeloma","Refractory multiple myeloma","MagnetisMM","MagnetisMM-32","Pomalidomide","Elotuzumab","Bortezomib","Carfilzomib","PF-06863135",{"date":41,"type":44},{"date":302,"type":44},"2024-02-08",{"date":304,"type":23},"2027-12-30",{"name":306,"class":51},"Pfizer",270,{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":24,"phases":318,"briefSummary":319,"conditions":320,"keywords":322,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":349},"100525272","phase-3-a-study-of-first-line-olomorasib-ly3537982-and-pembrolizumab-with-or-without-chemotherapy-in-patients-with-advanced-kras-g12c-mutant-non-small-cell-lung-cancer-100525272","NCT06119581","A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer","SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression","SUNRAY-01","Inclusion Criteria:\n\n* Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.\n* Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label).\n* Must have disease with evidence of KRAS G12C mutation.\n* Must have known programmed death-ligand 1 (PD-L1) expression\n\n  * Part A: Greater than or equal to (≥)50 percent (%).\n  * Part B: 0% to 100%.\n  * Part C: \\\u003C50%.\n* Must have measurable disease per RECIST v1.1.\n* Must have an ECOG performance status of 0 or 1.\n* Estimated life expectancy ≥12 weeks.\n* Ability to swallow capsules.\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 a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1\u002F2\u002F3.\n* Have had any of the following prior to randomization:\n\n  \\-- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC.\n\n  \\--- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated:\n* Have known active central nervous system metastases and\u002For carcinomatous meningitis.\n\nExclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)\n\n* Have predominantly squamous cell histology for NSCLC\n* Only for participants with mild to moderate renal insufficiency: Unable to avoid aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) two days before (5 days for long acting NSAIDs), day of, and two days after administration of pemetrexed\n* Is unable or unwilling to take folic acid or vitamin B12 supplementation.",{"count":317,"type":23},1264,[66],"The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.",[185,321],"Neoplasm Metastasis",[124,323,324,325,326,327,328,329,330,331,31,332,38,321,333,334,335,336,337,338,339,33,340,341,342],"KRAS G12 Lung Cancer","Advanced Lung Cancer","Metastatic Lung Cancer","KRAS G12C inhibitor","KRAS G12C Positive","KRAS Mutation","KRAS G12 Mutation","Lung Cancer Mutation","Olomorasib","Neoplastic Processes","Non-Small Cell Lung Cancer","Non-Small Cell Lung Cancer (NSCLC)","Antineoplastic Agents","Respiratory Tract Neoplasms","Thoracic Neoplasms","Neoplasms by Site","Neoplasms","Carcinoma, Bronchogenic","Bronchial Neoplasms","Lung Neoplasms",{"date":41,"type":44},{"date":345,"type":44},"2023-12-21",{"date":347,"type":23},"2031-01",{"name":76,"class":51},418,{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":18,"minAge":358,"maxAge":234,"enrollmentInfo":359,"targetDuration":4,"studyType":24,"phases":361,"briefSummary":362,"conditions":363,"keywords":365,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":373},"100478423","phase-3-a-study-of-mirikizumab-ly3074828-in-pediatric-participants-with-crohns-disease-100478423","NCT05509777","A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease","A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease","AMAY","Inclusion Criteria:\n\n* Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.\n* Participants have moderately to severely active CD (as defined by a baseline PCDAI score ≥30).\n* Participants must have endoscopy with evidence of active CD defined as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0.\n* Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor.\n\nExclusion Criteria:\n\n* Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery.\n* Participants must not have an abscess.\n* Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.","2 Years",{"count":360,"type":23},90,[66],"Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease.\n\nStudy periods for the intervention-specific appendix (ISA) will be as follows:\n\n* A 12-week induction period\n* A maintenance period from Week 12 to Week 52, and\n* A safety follow-up period up to 16 weeks.\n\nThe study will last about 74 weeks and may include up to 19 visits.",[364],"Crohn's Disease",[366],"Inflammatory Bowel Disease",{"date":41,"type":44},{"date":369,"type":44},"2024-03-13",{"date":371,"type":23},"2028-04",{"name":76,"class":51},81,{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":18,"minAge":381,"maxAge":382,"enrollmentInfo":383,"targetDuration":4,"studyType":24,"phases":385,"briefSummary":386,"conditions":387,"keywords":389,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":396,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":360},"100453322","phase-3-venetoclax-in-children-with-relapsed-acute-myeloid-leukemia-aml-100453322","NCT05183035","Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)","A Randomized Phase 3 Trial of Fludarabine\u002FCytarabine\u002FGemtuzumab Ozogamicin With or Without Venetoclax in Children With Relapsed AML","Inclusion Criteria\n\n* Participants must have enrolled on APAL2020SC, NCT Number: NCT04726241 prior to enrollment on ITCC-101\u002FAPAL2020D. (This is only applicable for participants in USA\u002FCanada\u002FAustralia\u002FNew Zealand sites\u002FBlood Cancer United territory).\n* Participants must be \\>28 days of age and \\\u003C 22 years of age at enrollment.\n* Participants must have one of the following:\n\n  1. Children, adolescents, and young adults with AML without demonstrated FLT3\u002Finternal tandem duplication (ITD) mutation. Ideally, the status of the mutation needs to be proven in the current relapse. Nevertheless, patients with previous FLT3\u002FITD negative test from prior lines can be included based on local results in order to not delay the start of treatment.\n  2. And participants must have AML which is either:\n\n     * Untreated second relapse, in participants who are sufficiently fit to undergo another round of intensive chemotherapy, or\n     * Untreated first relapse, in participants who cannot tolerate additional anthracycline containing chemotherapy per investigator discretion.\n* Participants must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2 (≥ 50% Lansky or Karnofsky score).\n* Participants must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to start of protocol treatment:\n\n  1. Cytotoxic chemotherapy: Must not have received cytotoxic chemotherapy within 14 days prior to start of protocol treatment, except for corticosteroids, low dose cytarabine or hydroxyurea that can be given up to 24 hours prior to start of protocol treatment.\n  2. Intrathecal cytotoxic therapy: No wash-out time is required for participants having received any combination of intrathecal cytarabine, methotrexate, and\u002For hydrocortisone.\n  3. Antibodies: ≥ 21 days must have elapsed from infusion of last dose of an antibody-drug conjugate before start of protocol treatment. For unmodified antibodies or T cell engaging antibodies, 2 half-lives must have elapsed before start of protocol treatment. Any toxicity related to prior antibody therapy must be recovered to Grade ≤ 1.\n  4. Interleukins, Interferons and Cytokines (other than Hematopoietic Growth Factors): ≥ 21 days after the completion of interleukins, interferon or cytokines (other than Hematopoietic Growth Factors) before start of protocol treatment.\n  5. Hematopoietic growth factors: ≥ 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or ≥7 days for short-acting growth factor before start of protocol treatment.\n  6. Radiation therapy (RT) (before start of protocol treatment):\n\n     * ≥ 14 days have elapsed for local palliative RT (small port);\n     * ≥ 84 days must have elapsed if prior craniospinal RT or if ≥ 50% radiation of pelvis;\n     * ≥ 42 days must have elapsed if other substantial bone marrow (BM) radiation.\n  7. Stem Cell Infusions (before start of protocol treatment):\n\n     * ≥ 84 days since allogeneic (non-autologous) bone marrow or stem cell transplant (with or without total body irradiation \\[TBI\\]) or boost infusion (any stem cell product; not including donor lymphocyte infusion \\[DLI\\]);\n     * No evidence of active graft versus host disease (GVHD).\n  8. Participants who are receiving cyclosporine, tacrolimus or other agents to treat or prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial. Participants must be off medications to treat or prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant for at least 14 days prior to enrollment.\n  9. Cellular Therapy: ≥ 42 days after the completion of donor lymphocyte infusion (DLI) or any type of cellular therapy (e.g., modified T cells, natural killer \\[NK\\] cells, dendritic cells, etc.) before start of protocol treatment.\n  10. Participants with prior exposure to venetoclax are eligible in this trial.\n* Adequate organ function:\n\n  1. Adequate Renal Function defined as:\n\n     * Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 60ml\u002Fmin\u002F1.73 m\\^2, or\n     * Normal serum creatinine based on age\u002Fsex\n  2. Adequate Liver Function defined as:\n\n     * Direct bilirubin \\\u003C 1.5 x upper limit of normal (ULN), and\n     * Alkaline phosphatase ≤ 2.5 x ULN, and\n     * Serum glutamic pyruvic transaminase (SGPT) alanine aminotransferase (ALT) ≤ 2.5 x ULN. If higher transaminases outside these ranges (up to 5x ULN) are due to a radiographically identifiable leukemia infiltrate, the participant will remain eligible. Transaminase elevation up to 5x ULN is also allowed in case of steatosis on echography.\n  3. Cardiac performance: Minimum cardiac function defined as:\n\n     * No history of congestive heart failure in need of medical treatment\n     * No pre-treatment diminished left ventricular function on echocardiography (shortening fraction \\[SF\\] \\\u003C 25% or ejection fraction \\[EF\\] \\\u003C 40%)\n     * No signs of congestive heart failure at presentation of relapse.\n* Participant, parent or guardian must sign and date informed consent and pediatric assent (when required), prior to the initiation of screening or study specific procedures, according to local law and legislation.\n\nExclusion Criteria\n\n* Participants who in the opinion of the investigator may not be able to comply with the study requirements of the study, are not eligible.\n* Participants with Down syndrome.\n* Participants with Acute promyelocytic leukemia (APL) or Juvenile myelomonocytic leukemia (JMML).\n* Participants with isolated CNS3 disease or symptomatic CNS3 disease.\n* Participants with malabsorption syndrome or any other condition that precludes enteral administration of venetoclax.\n* Participants who are currently receiving an investigational drug other than those specified for this study.\n* Participants with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known congenital bone marrow failure syndrome.\n* Participants with known prior allergy to any of the medications used in protocol therapy.\n* Participants with documented active, uncontrolled infection at the time of study entry.\n* Known hepatitis C virus (HCV), hepatitis B virus (HBV) (known positive hepatitis B virus (HBV) surface antigen (HBsAg) results), or human immunodeficiency virus (HIV) infection.\n* Concomitant Medications\n\n  * Participants who have received strong and moderate CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort within 7 days of the start of study treatment.\n  * Participants who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit within 3 days of the start of study treatment.\n  * Participants who have hypersensitivity to the active substance or to any of the excipients listed in summary of product characteristics (SPC).\n* Pregnancy or Breast-Feeding:\n\n  * Participants who are pregnant or breast-feeding.\n  * Participants of reproductive potential may not participate unless they have agreed to use a highly effective contraceptive method per Clinical Trial Facilitation Group (CTFG) guidelines for the duration of study therapy and at least 30 days after last dose of venetoclax, or 7 months after gemtuzumab ozogamicin treatment, or for 6 months after the completion of all study therapy, whichever is longer.\n  * Male participants must use a condom during intercourse and agree not to father a child or donate sperm during therapy and for the duration of study therapy and at least 30 days after last dose of venetoclax or 4 months after last dose of gemtuzumab ozogamicin, 6 months from the last dose of cytarabine, or 90-days after last exposure to any other chemotherapy, whichever is longer.\n\nAdditional criteria to receive a gemtuzumab ozogamicin infusion:\n\nGemtuzumab ozogamicin should not be given:\n\n* to participants with history of veno-occlusive disease (VOD)\u002FSinusoidal obstruction syndrome (SOS) grade 3 or 4\n* to participants with CD33 negative leukemic blasts (determined at local lab)\n\nNote that these participants are eligible for the study but will not be treated with gemtuzumab ozogamicin.","29 Days","21 Years",{"count":384,"type":23},130,[66],"A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine\u002Fcytarabine\u002Fgemtuzumab ozogamicin \\[GO\\]) improves survival of children\u002Fadolescents\u002Fyoung adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.",[388],"Acute Myeloid Leukemia",[390,391,392,393,394,395],"Venetoclax","Gemtuzumab Ozogamicin","Fludarabine","Cytarabine","Relapsed refractory","Azacitidine",{"date":41,"type":44},{"date":398,"type":44},"2022-10-01",{"date":400,"type":23},"2031-04",{"name":402,"class":170},"PedAL BCU, LLC",{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":18,"minAge":358,"maxAge":411,"enrollmentInfo":412,"targetDuration":4,"studyType":24,"phases":413,"briefSummary":414,"conditions":415,"keywords":419,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":430},"100427330","phase-3-a-master-protocol-amaz-a-study-of-mirikizumab-ly3074828-in-pediatric-participants-with-ulcerative-colitis-or-crohns-disease-shine-on-100427330","NCT04844606","A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)","A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease","SHINE-ON","Inclusion Criteria:\n\n* Participants from originating studies (I6T-MC-AMBA \\[NCT05784246\\], I6T-MC-AMBU \\[NCT04004611\\], I6T-MC-AMAM \\[NCT03926130\\]) , I6T-MC-AMAY \\[NCT05509777\\]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab\n* Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.\n* Female participants must agree to contraception requirements.\n\nExclusion Criteria:\n\n* Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant.\n* Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.\n* Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.\n* Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation.\n* Participants must not have adenomatous polyps that have not been removed.\n* Participants must not be pregnant or breastfeeding.","19 Years",{"count":64,"type":23},[66],"The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.",[416,417,418,364],"Ulcerative Colitis","Ulcerative Colitis Chronic","Inflammatory Bowel Diseases",[420,421,422,423],"Pediatric Ulcerative Colitis","Pediatric Crohn's Disease","Pediatric UC","Pediatric CD",{"date":41,"type":44},{"date":426,"type":44},"2021-05-26",{"date":428,"type":23},"2030-12",{"name":76,"class":51},68,{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":24,"phases":440,"briefSummary":441,"conditions":442,"keywords":445,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":457},"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":439,"type":23},3500,[66],"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.",[443,444],"Solid Tumors","Hematologic Malignancies",[446,447,448,449],"PD1","PD-1","PDL1","PD-L1",{"date":43,"type":44},{"date":452,"type":44},"2018-08-21",{"date":454,"type":23},"2043-08-04",{"name":456,"class":51},"Merck Sharp & Dohme LLC",782,{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":467,"phases":4,"briefSummary":468,"conditions":469,"keywords":471,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":482,"locationsCount":484},"100653357","a-non-interventional-study-of-participants-with-bpdcn-treated-with-chemotherapy-100653357","NCT07785180","A Non-interventional Study of Participants With BPDCN Treated With Chemotherapy","Retrospective Study of Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Treated With Chemotherapy Agents","Inclusion Criteria:\n\n* Alive, deceased, or unreachable participants (as permitted by local regulation), aged ≥18 years at the start of first-line treatment for BPDCN, and treated with chemotherapy regimens (at a minimum) as first-line treatment for BPDCN from May 2016\n* Diagnosed with BPDCN, based on clinical, laboratory, and imaging (where performed per institutional practice) assessments, with a demonstration of a specific immunophenotype (either by immunohistochemistry or flow cytometry), particularly CD4, CD56, and CD123\n* Participants (or their legally authorized representatives) who have signed the informed consent and privacy form, where required as per local regulation\n\nExclusion Criteria:\n\n* Participant has received an investigational agent as first-line therapy for BPDCN\n* Participant has received first-line therapy for BPDCN in an interventional clinical trial",{"count":466,"type":23},140,"OBSERVATIONAL","The main goal of this study is to investigate the effectiveness and safety of chemotherapy agents in the treatment of participants with BPDCN and to provide comparator arm data to the prospective ELZONRIS registry study (STML-401-0521).",[470],"Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)",[472,473,474,475,476],"BPDCN","Retrospective","STML-401-0521","ELZONRIS","Chemotherapy","2026-08-20",{"date":43,"type":44},{"date":480,"type":44},"2025-10-17",{"date":167,"type":23},{"name":483,"class":51},"Stemline Therapeutics, Inc.",67,{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":467,"phases":4,"briefSummary":495,"conditions":496,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":505},"100653352","a-study-to-characterize-high-risk-non-muscle-invasive-bladder-cancer-participants-in-portugal-100653352","NCT07784387","A Study to Characterize High-Risk Non-Muscle-Invasive Bladder Cancer Participants in Portugal","High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) Retrospective Cohort Study","BRITE","Inclusion criteria:\n\n* Bladder cancer diagnosis between January 1, 2016 and December 31, 2020\n* Tumor stage N0\u002Fx and M0\u002Fx plus any of the following: Tis (primary CIS); TaG3\u002FHG (high-grade non-invasive papillary carcinoma); or T1 (tumor invading subepithelial connective tissue)\n* Minimal follow-up time of 5 years unless there is premature death event\n\nExclusion criteria:\n\n* Tumor stage at diagnosis classified as TaG1-2, T2-T4, N1-3, or M1\n* History of radical cystectomy performed either prior to the HR-NMIBC index diagnosis or for an indication unrelated to the index HR-NMIBC\n* Participation in any interventional clinical trial during the observation period",{"count":494,"type":23},250,"The purpose of this study is to understand how the participants with high-risk non-muscle invasive bladder cancer are diagnosed, treated, and cared for in regular clinical practice in Portugal. HR-NMIBC is an early-stage bladder cancer that is limited to the inner lining of bladder but has a considerable high chance of cancer coming back or worsening.",[497],"Urinary Bladder Neoplasms",{"date":43,"type":44},{"date":500,"type":23},"2026-08-31",{"date":502,"type":23},"2028-02-29",{"name":504,"class":51},"Janssen-Cilag Farmaceutica Ltda.",1,{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":514,"enrollmentInfo":515,"targetDuration":4,"studyType":24,"phases":517,"briefSummary":518,"conditions":519,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":527,"locationsCount":528},"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":516,"type":23},1431,[121],"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.",[520,521,522],"Ulcerative Colitis (UC)","Ulcerative Colitis, Active Moderate","Ulcerative Colitis, Active Severe",{"date":186,"type":44},{"date":525,"type":44},"2026-03-26",{"date":74,"type":23},{"name":76,"class":51},259,{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":18,"minAge":536,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":24,"phases":539,"briefSummary":540,"conditions":541,"keywords":543,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":544,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":551},"100610646","phase-2-study-of-abbv-142-to-assess-adverse-events-and-change-in-disease-activity-in-adult-participants-with-idiopathic-pulmonary-fibrosis-100610646","NCT07230288","Study of ABBV-142 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Idiopathic Pulmonary Fibrosis","A Phase 2a Multicenter Platform Study of Investigational Products for the Treatment of Adult Subjects With Idiopathic Pulmonary Fibrosis","Inclusion Criteria:\n\n\\- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) within 7 years prior to screening, confirmed by the investigator at screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained within 12 months of the screening visit and verification of usual interstitial pneumonia(UIP) or probable UIP.\n\nExclusion Criteria:\n\n* History of stroke within 6 months prior to screening\n* In the opinion of the investigator, other clinically significant pulmonary abnormalities\n* History of any malignancy up to 5 years prior screening visit, except for successfully treated nonmelanoma skin cancer or localized carcinoma in situ of the cervix.","40 Years",{"count":538,"type":23},165,[121],"Idiopathic Pulmonary Fibrosis (IPF) is a rare, long-lasting lung disease that causes scarring of lung tissue, shortness of breath, and loss of lung function. IPF leads to significant loss of quality of life and shortened lifespan. This study is a platform study evaluating different types of treatments in patients with IPF. A platform study is a type of study that uses a single master protocol to evaluate different study treatments allowing for new study treatments or substudies to be added or closed over time. The main goals of the study are to evaluate the safety, tolerability (the degree to which the adverse symptoms can be handled by the patients during the study) and efficacy (how well study treatment works) of the study treatments, including ABBV-142 in Substudy 1 (SS1).\n\nABBV-142 is an investigational drug being developed for the treatment of IPF. In SS1, participants will be randomly assigned to one of the 2 groups to receive either ABBV-142 or a matching placebo. This study is \"double-blind\", meaning that neither the participants nor the study doctors know who is given which study treatment. Approximately 165 adult participants with IPF will be enrolled in approximately 125 sites across the world.\n\nParticipants will receive ABBV-142 or matching placebo for 52 weeks during the double-blind treatment period. Eligible participants may receive ABBV-142 for 52 weeks in open-label treatment period. All participants will be followed for 120 days.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[542],"Idiopathic Pulmonary Fibrosis",[542],{"date":41,"type":44},{"date":546,"type":44},"2026-01-23",{"date":548,"type":23},"2029-09",{"name":550,"class":51},"AbbVie",49,{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":62,"enrollmentInfo":559,"targetDuration":4,"studyType":24,"phases":561,"briefSummary":562,"conditions":563,"keywords":564,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":569,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":575},"100610034","phase-3-a-study-of-baricitinib-ly3009104-to-preserve-beta-cell-function-in-children-and-adults-newly-diagnosed-with-type-1-diabetes-baricade-preserve-100610034","NCT07222332","A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)","A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to \u003C36 Years","Inclusion Criteria:\n\n* Have a new diagnosis of type 1 diabetes within 100 days prior to starting study intervention\n* Have at least one diabetes-related autoantibody found at screening\n* Show signs of remaining beta-cell function\n\n  * stimulated (peak or 90 min) C-peptide ≥0.2 nmol\u002FL (0.6 ng\u002FmL) at screening\n* Weigh at least 8 kilograms (kg) (18 pounds) at screening\n\nExclusion Criteria:\n\n* Have any other type of diabetes including gestational\n* Have uncontrolled high blood pressure\n* Have had a heart attack, heart disease, stroke, or heart failure\n* Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy\n* Have a current or recent clinically serious medical condition or infection",{"count":560,"type":23},300,[66],"The purpose of this study is to find out if baricitinib can preserve beta-cell function in participants newly diagnosed with type 1 diabetes. Participation in the study will last about 60 weeks.",[69],[565,566,567,568],"T1DM","Children","New-onset","Beta-cell Function",{"date":186,"type":44},{"date":571,"type":44},"2026-02-05",{"date":573,"type":23},"2028-07",{"name":76,"class":51},138,{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":24,"phases":586,"briefSummary":587,"conditions":588,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":590,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":596},"100609703","a-clinical-study-of-sotatercept-mk-7962-in-people-with-pulmonary-arterial-hypertension-mk-7962-038-100609703","NCT07218029","A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)","An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)","SOTERIA","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early\n* Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements\n* Must have the ability to understand and provide documented informed consent\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Did not participate in a sotatercept PAH parent study\n* Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.\n* Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept\n* Is a female who is pregnant or breastfeeding\n* Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study\n* Is currently enrolled in another investigational product study other than a sotatercept study\n* Is incapacitated",{"count":585,"type":23},815,[66],"Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse.\n\nSotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH.\n\nThis is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.",[589],"Pulmonary Arterial Hypertension",{"date":186,"type":44},{"date":592,"type":44},"2021-05-12",{"date":594,"type":23},"2028-12-07",{"name":456,"class":51},134,{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":4,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":604,"minAge":19,"maxAge":4,"enrollmentInfo":605,"targetDuration":4,"studyType":24,"phases":607,"briefSummary":608,"conditions":609,"keywords":611,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":619,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":64},"100609368","phase-3-a-study-of-xaluritamig-plus-abiraterone-versus-investigators-choice-in-participants-with-chemotherapy-nave-metastatic-castration-resistant-prostate-cancer-100609368","NCT07213674","A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer","A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n* Participant has provided informed consent before initiation of any study-specific activities\u002Fprocedures.\n* Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.\n* Participant must have histological, pathological, and\u002For cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.\n* Metastatic castration-resistant prostate cancer (mCRPC) with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within 28 days before enrollment.\n* Evidence of progressive disease (PD), defined as 1 or more PCWG3-modified RECIST 1.1 criteria:\n\n  * Serum PSA progression is defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimum start value is 2.0 ng\u002FmL.\n  * Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.\n  * Progression of bone disease defined by the appearance of at least 2 new bone lesions(s) by bone scan (as per the 2+2 PCWG3-modified RECIST 1.1 criteria).\n* Participants must have had prior orchiectomy and\u002For ongoing androgen-deprivation therapy (ADT) and a castrate level of serum testosterone (\\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL).\n* Prior disease progression on 1, and only 1, androgen receptor pathway inhibitor (ARPI) (either enzalutamide, apalutamide, or darolutamide) is required.\n* Participants intended to receive cabazitaxel must have previously received ≤ 6 cycles of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\nDisease Related:\n\n* Participants with a history of central nervous system (CNS) metastases.\n* Unresolved toxicities from prior antitumor therapy not having resolved to CTCAE version 5.0 grade 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor.\n\nPrior\u002FConcomitant Therapy:\n\n* Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.\n* Prior disease progression on or intolerance to abiraterone.\n* Prior treatment with any chemotherapy regimen in the mCRPC setting and\u002For \\> 6 cycles of docetaxel treatment in the mHSPC setting.\n* Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks before first dose of study treatment with the following exceptions:\n\n  * Androgen receptor pathway inhibitors (ARPIs; enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment.\n  * Androgen suppression therapy (eg, luteinizing hormone-releasing hormone\u002Fgonadotrophin releasing hormone \\[LHRH\u002FGnRH\\] analogue \\[agonist\u002Fantagonist\\]) is permitted.\n* Prior radioligand therapy (RLT) within 8 weeks of first dose of study treatment.\n* Prior radionuclide therapy (radium-223) within 2 months of first dose of study treatment.\n* Prior palliative radiotherapy within 2 weeks before first dose of study treatment. Participants must have recovered from all radiation-related toxicities.\n* Concurrent cytotoxic chemotherapy, ARPI, immunotherapy, RLT, poly adenosine diphosphate ribose polymerase (PARP) inhibitor, biological therapy, investigational therapy.\n* Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment.\n* Prior CD3-directed therapy.","MALE",{"count":606,"type":23},750,[66],"The primary objective of this study is to compare overall survival (OS) in participants receiving xaluritamig plus abiraterone against investigator's choice (docetaxel, cabazitaxel, or abiraterone).",[610],"Metastatic Castration-resistant Prostate Cancer",[612,613,614,615,616,617,618],"Prostate Cancer","Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer","Xaluritamig","Abiraterone","Abiraterone Acetate","Docetaxel","Cabazitaxel",{"date":186,"type":44},{"date":621,"type":44},"2025-11-28",{"date":623,"type":23},"2032-08-30",{"name":625,"class":51},"Amgen",{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":4,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":633,"targetDuration":4,"studyType":24,"phases":635,"briefSummary":636,"conditions":637,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":638,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":269},"100607987","phase-3-beamion-lung-3-adjuvant-zongertinib-vs-standard-treatment-in-people-with-completely-resected-stage-ii-iiib-nsclc-harboring-activating-her2-tkd-mutations-100607987","NCT07195695","Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations","Beamion LUNG-3: A Randomized, Controlled, Multi-center Trial Evaluating Zongertinib as an Adjuvant Monotherapy Compared With Standard of Care in Patients With Early-stage, Resectable Non-small Cell Lung Cancer (Stage II-IIIB) Harboring Tyrosine Kinase Domain Activating HER2 Mutations","Inclusion criteria:\n\n1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n2. Patients must be ≥18 years old or over the legal age of consent in their country\n3. Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use dual highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information and in the study protocol\n4. HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2) mutations\n5. Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC\n6. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status\n7. Staging: Pretherapeutic classification not exceeding Stage IIIB\n8. Performance status and organ function:\n\n   * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n   * Adequate organ function based on laboratory values Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Diagnosis of NSCLC with mixed histology\u002Fpositive neuroendocrine markers (synaptophysin\u002FCD56)\n2. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization\n3. Treatment with radiation therapy for primary NSCLC\n4. Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK))\n5. Any investigational drug within 5 half-lives of the compound or any of its related material, if known\n6. History or presence of\n\n   * Active or known pre-existing or history of non-infectious interstitial lung disease\u002Fpneumonitis\n   * Active infectious disease requiring systemic therapy\n   * Uncontrolled gastrointestinal disorders affecting drug intake\u002Fabsorption\n   * Previous or concomitant malignancies within the last 3 years, except certain effectively treated cancers\n   * Significant and\u002For uncontrolled cardiovascular abnormalities, QT interval corrected for heart rate by Fridericia formula (QTcF) \\>470 msec, or ejection fraction \\\u003C50% Further exclusion criteria apply.",{"count":634,"type":23},400,[66],"Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating HER2 tyrosine kinase domain (TKD) mutations. Eligible participants must have undergone curative-intent surgery and received guideline-appropriate perioperative systemic therapy, either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy.\n\nParticipants are randomized 1:1 to receive zongertinib or standard of care, which may consist of approved adjuvant immunotherapy or active surveillance, based on local practice guidelines. The main purpose of the study is to determine whether zongertinib can prolong disease-free survival compared to standard treatment. Safety and patient-reported outcomes are also assessed.",[207],{"date":186,"type":44},{"date":640,"type":44},"2026-01-16",{"date":642,"type":23},"2036-09-02",{"name":644,"class":51},"Boehringer Ingelheim",{"id":646,"slug":647,"hasResults":12,"nctId":648,"briefTitle":649,"officialTitle":650,"acronym":4,"eligibilityCriteria":651,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":652,"targetDuration":4,"studyType":24,"phases":654,"briefSummary":655,"conditions":656,"keywords":658,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":673,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":678,"locationsCount":679},"100605631","phase-3-a-master-protocol-of-multiple-agents-in-adults-with-metabolic-dysfunction-associated-steatotic-liver-disease-synergy-outcomes-100605631","NCT07165028","A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)","A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes","Inclusion Criteria:\n\n* Have liver fat content ≥8%\n* Have ELF score of ≥9 and ≤10.8 at screening\n* Have VCTE LSM ≥10 kilopascal (kPa) and \\\u003C20 kPa at screening\n\nExclusion Criteria:\n\n* Have any other type of liver disease other than MASLD\n* Have a body mass index (BMI) \\\u003C25 kilogram per square meter (kg\u002Fm2)\n* Prior decompensated liver disease (history of esophageal\u002Fgastric varices, ascites, hepatic encephalopathy)\n* Have lost more than 11 pounds within the 3 months prior to screening\n* Have a hemoglobin A1c (HbA1c) greater than 10%\n* Have type 1 diabetes",{"count":653,"type":23},4500,[66],"The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll about 4,500 adults and will run for approximately 224 weeks. Participants may have up to approximately 25 to 30 clinic visits throughout the study to monitor their health, complete study procedures, and assess liver function and disease progression.\n\nOnce the study is complete, eligible participants may participate in an optional 2-year extension study, in which all participants will receive either retatrutide or tirzepatide, even if they received placebo in the main study.",[657],"Metabolic Dysfunction-Associated Steatotic Liver Disease",[659,660,661,662,663,664,665,666,667,668,669,670,671,672],"Nonalcoholic Steatohepatitis","NASH","Fatty Liver","Fatty Liver Disease","SLD","Metabolic Dysfunction-Associated Fatty Liver Disease","MAFLD","Non-alcoholic Fatty Liver Disease","NAFLD","Hepatic Steatosis","Liver Related Outcomes","GLP1","Incretin","Non-Invasive Test",{"date":186,"type":44},{"date":675,"type":44},"2025-10-15",{"date":677,"type":23},"2032-08",{"name":76,"class":51},565,{"id":681,"slug":682,"hasResults":12,"nctId":683,"briefTitle":684,"officialTitle":685,"acronym":4,"eligibilityCriteria":686,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":687,"targetDuration":4,"studyType":24,"phases":689,"briefSummary":690,"conditions":691,"keywords":693,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":699,"startDateStruct":700,"completionDateStruct":702,"leadSponsor":704,"locationsCount":706},"100595454","phase-2-imeroprubart-in-adult-participants-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp-100595454","NCT07032662","Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","Inclusion Criteria:\n\n* Have met clinical diagnostic criteria for typical CIDP or one of the following CIDP variants: multifocal CIDP or motor CIDP per the 2021 European Academy of Neurology\u002FPeripheral Nerve Society (EAN\u002FPNS) Guideline on Diagnosis and Treatment of CIDP.\n* Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN\u002FPNS guideline on diagnosis and treatment of CIDP.\n* Are currently on, and have been receiving chronic, stable doses of systemic corticosteroids (i.e., daily or every other day oral or pulse regimen), or immunoglobulin therapy (IVIg or SCIg) ± low dose oral corticosteroids for at least 3 months for the treatment of CIDP at the time of the Screening Visit.\n\nAdditional inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Have current or prior history of IgM paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies.\n* Have distal, sensory, or focal CIDP, or have a diagnosis of autoimmune nodopathy per the EAN\u002FPNS guideline on diagnosis and treatment of CIDP.\n* Have polyneuropathy of causes other than CIDP including but not limited to:\n\n  * Multifocal motor neuropathy\n  * Hereditary demyelinating neuropathy\n  * Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS)\n  * Lumbosacral radiculoplexus neuropathy\n  * Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies\n  * Drug- or toxin-induced\n* Have diabetes mellitus (DM) and meets any of the following criteria:\n\n  * Does not have both typical CIDP and strong evidence of demyelination on nerve conduction study.\n  * In the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP.\n  * In the opinion of the Investigator, there is evidence of poorly controlled DM at screening.\n* Have a history of myelopathy or evidence of central demyelination. Additional exclusion criteria are defined in the protocol.",{"count":688,"type":23},162,[121],"This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.",[692],"Chronic Inflammatory Demyelinating Polyneuropathy",[692,694,695,696,697,698],"IMVT-1402","Monoclonal antibody","Human immunoglobulin G1 (IgG1)","CIDP","Imeroprubart",{"date":186,"type":44},{"date":701,"type":44},"2025-03-18",{"date":703,"type":23},"2030-05",{"name":705,"class":51},"Immunovant Sciences GmbH",141,""]