[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hoffmann-La Roche\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":596},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,83,0,25,[9,44,65,85,108,136,157,178,202,223,245,267,286,305,326,370,392,415,437,457,478,499,520,549,573],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100640944","phase-2-a-study-to-evaluate-mosunetuzumab-in-participants-with-systemic-lupus-erythematosus-with-or-without-active-lupus-nephritis-100640944",false,"NCT07598396","A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis","A Phase II Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Mosunetuzumab in Patients With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis","SOLUNA","Inclusion Criteria:\n\n* Diagnosis of SLE for ≥ 6 months as assessed using the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) Classification Criteria at screening\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required\n* Treatment with investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment and during the study\n* Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening, or any planned surgery or procedure requiring hospitalization during the 12 weeks following study drug administration\n* Alcohol or substance abuse within the 12 months prior to screening\n* Active infection of any kind, excluding fungal infection of the nail beds\n* Any major episode of infection as defined by the protocol\n* History of serious recurrent or chronic infection\n* History of progressive multifocal leukoencephalopathy (PML)\n* Tuberculosis (TB) infection\n* History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years\n* Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within the 12 months prior to screening or during screening\n* Catastrophic or severe antiphospholipid syndrome within the 12 months prior to screening or during screening. Antiphospholipid syndrome adequately controlled by anticoagulant therapy for at least 2 months prior to screening is acceptable\n* High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions\n* Active severe or unstable lupus-associated neuropsychiatric disease or where, in the opinion of the investigator, it is likely to require treatment with protocol-disallowed therapies. Examples of neuropsychiatric SLE manifestations include, but are not limited to the following: meningitis, retinitis, cerebral vasculitis, myelopathy, demyelination syndromes, acute confusional state, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus or seizures, cerebellar ataxia, and mononeuritis multiplex\n* History of any non-SLE disease treated with oral, intravenous, or intramuscular corticosteroids for more than 14 days in total during the one year prior to Day 1\n* History of treatment with any T cell-engaging bispecific antibodies or CAR-T therapy within the past 2 years\n* Receipt of any live or attenuated vaccine in the 28 days prior to or during screening","ALL","18 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study will assess how mosunetuzumab works in people who have systemic lupus erythematosus (SLE) who may or may not also have active lupus nephritis (LN).",[28,29,30],"Lupus","Systemic Lupus Erythematosus","Lupus Nephritis","RECRUITING","2026-08-20",{"date":34,"type":35},"2026-08-21","ACTUAL",{"date":37,"type":35},"2026-05-25",{"date":39,"type":22},"2028-08-31",{"name":41,"class":42},"Hoffmann-La Roche","INDUSTRY",21,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100640867","phase-2-an-extension-study-to-assess-long-term-safety-and-efficacy-of-afimkibart-in-participants-with-rheumatoid-arthritis-100640867","NCT07620392","An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis","An Extension Study to Evaluate the Long-term Safety and Efficacy of Afimkibart (RO7790121) in Patients With Rheumatoid Arthritis Who Participated in Previous Afimkibart Clinical Trials","dRAvite-LTE","Inclusion Criteria:\n\n* Completed the treatment period of the parent study\n* Agreement to adhere to the contraception requirements\n* Continued to be evaluated at the follow-up visit of the parent study and achieved improvement in the SJC66\u002FTJC68 relative to baseline\n\nExclusion Criteria:\n\n* Withdrawal of consent and\u002For premature discontinuation from parent study\n* Any permanent discontinuation of study drug in parent study\n* Use of a prohibited therapy during the parent study\n* Evidence of any new or uncontrolled concomitant disease that, in the investigator's judgment, would preclude participant participation in the trial",{"count":53,"type":22},120,[25],"The study will evaluate the long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response or intolerance to tumor necrosis factor (TNF) and\u002For Janus kinase (JAK) inhibitors, and who were previously treated with Afimkibart.",[57],"Rheumatoid Arthritis",{"date":34,"type":35},{"date":60,"type":35},"2026-06-03",{"date":62,"type":22},"2033-07-08",{"name":41,"class":42},9,{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100627938","a-study-to-develop-a-blood-based-test-for-aiding-the-diagnosisprognosis-of-traumatic-brain-injury-in-adults-and-for-monitoring-the-development-of-secondary-events-in-patients-diagnosed-with-traumatic-brain-injury-100627938","NCT07455136","A Study to Develop a Blood-based Test for Aiding the Diagnosis\u002FPrognosis of Traumatic Brain Injury in Adults and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury","A Multicenter Prospective Study to Develop a Blood-based Biomarker Test for Aiding the Diagnosis\u002FPrognosis of Traumatic Brain Injury in Adult Subjects (CLIN12.1) and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury (CLIN12.2)","Inclusion Criteria:\n\n* Presenting to the Emergency Department with a biomechanically plausible mechanism of non-penetrating traumatic brain injury (TBI; direct impact: blow to the head, head against object, object against head; acceleration\u002Fdeceleration)\n* Acute brain CT completed for standard of care\n\nFurther Inclusion Criteria (specific for CLIN12.2):\n\n* Admitted to the hospital with radiographic evidence of acute TBI\n* Admitted to the intensive care unit at risk for decline related to TBI\n\nExclusion Criteria:\n\n* Prior neurosurgical intervention within the last 6 months\n* Major debilitating neurological disease (such as, but not limited to: stroke, CVA, mild cognitive impairment, Alzheimer's disease, Amyotrophic lateral sclerosis, Parkinson's disease, Huntington's disease, Frontotemporal dementia, tumor, epilepsy, unmanaged seizure disorder), impairing baseline awareness, cognition, or validity of outcomes assessments\n* Major debilitating baseline mental health disorders (such as but not limited to schizophrenia or bipolar disorder) that would interfere with follow-up and the validity of outcome assessments\n* Significant pre-existing conditions that would interfere with follow-up and outcome assessment (such as, but not limited to: chronic kidney disease, chronic cardiovascular comorbidities, alcohol or substance use disorder)\n* History of melanoma\n* Primary diagnosis of ischemic or hemorrhagic stroke\n* Any spinal Cord Injury (American Spinal Injury Association \\[ASIA\\] score of A-D)\n* Received chemotherapy or radiation currently or within the last year\n* Patients on psychiatric hold (e.g., 5150, 5250)\n* Current incarceration or in custody\n* Known inability to undergo an MRI\n* Currently receiving any interventional treatments as a part of an investigational study\u002Ftrial (drug, device, behavioral, treatment) at the time of enrollment and\u002For during the course of this study\n* Low likelihood of follow-up (e.g. participant or family indicating low interest, residence in another state or country, homelessness or lack of reliable contacts)\n* Any condition that, in the opinion of the investigator, could interfere in the proper execution of the study procedures and\u002For in their future permanence in the study",{"count":73,"type":22},2000,"OBSERVATIONAL","The study is intended to cover two purposes: first, to develop a blood-based biomarker test for aiding the diagnosis of traumatic brain injury (TBI) in adult participants and for prognosis of outcome of TBI (CLIN12.1); and second, for monitoring the development of secondary events in adult participants diagnosed with TBI (CLIN12.2).",[77],"Traumatic Brain Injury",{"date":34,"type":35},{"date":80,"type":35},"2026-02-09",{"date":82,"type":22},"2028-11-23",{"name":41,"class":42},14,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":18,"minAge":19,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100613830","phase-1-a-study-to-determine-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-ro7806881-in-healthy-participants-100613830","NCT07271693","A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants","A Phase I, Randomized, Investigator\u002FParticipant-blind, Parallel-group, Placebo-controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants","Inclusion Criteria:\n\n* Participants must be males or females who are overtly healthy as determined by medical evaluation\n* Participants must have body weight (BW) ≥ 40 kilograms (kg) (not applicable to Cohort A9) and body mass index (BMI) within the range 18-32 kilograms per square meter (kg\u002Fm\\^2) (inclusive)\n\nInclusion Criteria Specific to Cohort A9 (East Asian Cohort):\n\n* Must be of ethnic Chinese, Korean, or Japanese origin\n* Must have a BW \\>35 kg and BMI within the range 18-32 kg\u002Fm2 (inclusive)\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding, or intention to become pregnant during the study or within 6 months after the final dose of study treatment\n* History of any clinically significant autoimmune, gastrointestinal, renal, hepatic, pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, or allergic disease; metabolic disorder; cancer or cirrhosis\n* Latent tuberculosis (TB) or potentially active TB\n* Any major illness within 1 month before the screening examination or any febrile illness within 1 week prior to the screening visit and up to first dose administration\n* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study\n* History of hypersensitivity to biologic agents or any of the excipients in the formulation, or other allergy that contraindicates participation in the study\n* Live vaccines within 1 month of the first screening visit or during the screening period\n* Non-live vaccines within 2 weeks prior to dosing\n* Previous exposure to RO7806881\n* Positive hepatitis C virus (HCV) antibody test result\n* Positive test results for hepatitis B infection\n* Positive human immunodeficiency virus (HIV) antibody test result\n* Positive test result consistent with cytomegalovirus (CMV) or Epstein-Barr virus (EBV)",true,"50 Years",{"count":95,"type":22},128,[97],"PHASE1","The main purpose of this study is to evaluate the safety and tolerability of single and multiple ascending doses of RO7806881 in healthy participants.",[100],"Healthy Volunteers",{"date":34,"type":35},{"date":103,"type":35},"2025-12-22",{"date":105,"type":22},"2027-03-01",{"name":41,"class":42},1,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":18,"minAge":93,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":129,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},"100606576","phase-3-screening-study-to-determine-individuals-with-potential-trial-eligibility-for-alzheimers-disease-studies-100606576","NCT07177352","Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies","Master Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer's Disease Studies as Assessed by Biomarker Status and Cognition","TRAVELLER","Inclusion Criteria:\n\n* Ability and willingness to participate in an interventional clinical study, including meeting key eligibility criteria of linked interventional Roche AD studies (e.g., specific age ranges)\n* Ability and willingness to receive information about potential eligibility in an associated interventional Roche AD study\n\nExclusion Criteria:\n\n* Dependency in basic activities of daily living (bADLs) due to cognitive impairment\n* Visual or auditory impairment that would prevent them from performing the cognitive assessments (eyeglasses and hearing aids are permitted)\n* Any self-reported evidence or known diagnosis of a neurological or neurodegenerative condition that may lead to cognitive impairment other than AD\n* History of severe, clinically significant central nervous system trauma\n* Any serious medical condition that precludes a participant's safe participation and completion of a clinical study\n* For participants with a clinical diagnosis of MCI or mild AD: Previous AD diagnosis based on biomarker confirmation with an approved or validated rule in method (e.g., amyloid PET or cerebrospinal fluid, blood biomarker) is exclusionary","90 Years",{"count":118,"type":22},80000,[120],"PHASE3","This study is a pre-screening process used to assess participants' potential eligibility for Roche interventional Alzheimer's disease studies.",[123],"Alzheimers Disease",[125,126,127,128],"Early Alzheimers Disease","Mild Cognitive Impairment","Mild Dementia","Preclinical AD",{"date":34,"type":35},{"date":131,"type":35},"2025-07-02",{"date":133,"type":22},"2035-07-31",{"name":41,"class":42},212,{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":18,"minAge":93,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},"100581225","phase-3-a-study-of-36-week-refill-exchanges-of-port-delivery-system-pds-with-ranibizumab-in-namd-100581225","NCT06847542","A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD","A Phase IIIb, Multicenter, Single-arm Study Assessing the Effectiveness, Safety and Patient Reported Outcomes of a 36-week Refill Exchange Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration","Sightspire","Inclusion Criteria:\n\n* Initial diagnosis of nAMD within 24 months prior to screening\n* Previous treatment with at least 3 anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard of care within 6 months prior to screening\n* Demonstrated response to prior anti-VEGF IVT treatment since diagnosis\n* Availability of historical VA data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD\n* Availability of historical OCT image data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD\n* BCVA of 34 letters or better using ETDRS chart at a starting distance of 4 meters at screening and enrollment visits\n\nExclusion Criteria:\n\nA. Prior Ocular Treatment\n\nStudy Eye:\n\n* History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)\n* Previous treatment with corticosteroid intravitreal injection\n* Previous intraocular device implantation\n* History of vitreous hemorrhage\n* History of rhegmatogenous retinal detachment\n* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery\n* History of corneal transplant\n\nEither Eye:\n\n* History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the ranibizumab injections, study-related procedure preparations (including fluorescein), dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study\n* Prior participation in a clinical trial involving any experimental therapies for nAMD\n* Prior treatment with brolucizumab or gene therapy for nAMD\n\nB. Macular Neovascularization\u002FChoroidal Neovascularization (MNV\u002FCNV) Lesion Characteristics:\n\nStudy Eye:\n\n* Subretinal hemorrhage that involves the center of the fovea\n* Subfoveal fibrosis or subfoveal atrophy\n\nEither Eye:\n\n* CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorioretinopathy, or pathologic myopia\n* CNV masquerading lesions\n\nC. Concurrent Ocular Conditions:\n\nStudy Eye:\n\n* Subfoveal and\u002For juxtafoveal retinal pigment epithelial tear\n* Any concurrent intraocular condition that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results\n* Active intraocular inflammation\n* Retinal tears or peripheral retinal breaks on depressed fundus exam that are untreated or treated within 3 months prior to the enrollment visit\n* Aphakia or absence of the posterior capsule\n* Uncontrolled ocular hypertension or glaucoma\n* History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis\n* Trichiasis\n* Corneal neuropathy\n* Lagophthalmos or incomplete blink\n* Active or history of facial nerve palsy\u002Fparesis\n\nFellow (Non-study) Eye:\n\n\\- Non-functioning non-study eye defined as either: BCVA of hand motion or worse OR no physical presence of non-study eye (i.e., monocular)\n\nEither Eye:\n\n* Any active or history of uveitis\n* Active or history of keratitis, scleritis, endophthalmitis, or chronic blepharitis\n* Suspected or active ocular or periocular infectious conjunctivitis or endophthalmitis\n* Active or history of floppy eyelid syndrome\n* Active thyroid eye disease\n\nD. Concurrent Systemic Conditions:\n\n* Uncontrolled blood pressure\n* Active or history of autoimmune diseases\n* History of stroke within the last 3 months prior to informed consent\n* Atrial fibrillation diagnosed or worsened within the last 3 months prior to informed consent\n* History of myocardial infarction (MI) within the last 3 months prior to informed consent\n* Confirmed active systemic infection\n* History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study\n* Use of any systemic anti-VEGF agents\n* Chronic use of oral corticosteroids\n* Active cancer within 12 months of enrollment except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer",{"count":145,"type":22},250,[120],"The purpose of this study is to evaluate the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams\u002Fmilliliters (mg\u002FmL) refilled every 36 weeks (Q36W) in participants with nAMD.",[149],"Neovascular Age-related Macular Degeneration",{"date":34,"type":35},{"date":152,"type":35},"2025-11-27",{"date":154,"type":22},"2028-11-15",{"name":41,"class":42},60,{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":164,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":166,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},"100644214","phase-1-an-early-stage-study-in-multiple-clinics-of-how-afimkibart-may-affect-the-bodys-processing-of-medicines-that-rely-on-cytochrome-p450-enzymes-in-participants-with-ulcerative-colitis-100644214","NCT07665723","An Early-Stage Study in Multiple Clinics of How Afimkibart May Affect the Body's Processing of Medicines That Rely on Cytochrome P450 Enzymes in Participants With Ulcerative Colitis","A Phase I, Multicenter, Open-Label, Single-Agent Study to Assess the Pharmacokinetics of Cytochrome P450 Substrates After Treatment With Afimkibart in Participants With Moderately to Severely Active Ulcerative Colitis","Inclusion Criteria:\n\n* Body weight \\>= 40kg\n* Agreement to adhere to the contraceptive requirements\n\nUC Specific Inclusion Criteria:\n\n* Confirmed diagnosis of UC with supportive clinical, endoscopic, and histopathological evidence\n* Active UC confirmed by endoscopy (flexible sigmoidoscopy or colonoscopy) extending \\>=15 cm from the anal verge\n* Moderately to severely active UC, defined as an modified Mayo score of 5 to 9 points, including a Mayo endoscopic subscore of 2 or 3, confirmed through centrally read endoscopy\n\nExclusion Criteria:\n\nInflammatory Bowel Disease (IBD) Exclusion Criteria:\n\n* Current diagnosis of Crohn's disease (CD),abdominal\u002Fintrabdominal\u002Fperianal fistula and\u002For abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease\n* Presence of an ostomy or ileoanal pouch\n* Current diagnosis or suspicion of primary sclerosing cholangitis\n\nMedical History Exclusion Criteria:\n\n* Lack of peripheral venous access\n* Any major surgery within 6 weeks prior to screening or a major surgery planned during the study\n* History of alcohol, drug, or chemical abuse \\\u003C 1 year prior to screening","60 Years",{"count":7,"type":22},[97],"The purpose of this study is to evaluate the disease-drug-drug interaction (DDDI) potential of afimkibart (also known as RO7790121). This will be assessed by the characterization of the pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme substrates alone and after administration of afimkibart in participants with moderately to severely active ulcerative colitis (UC).",[169],"Active Ulcerative Colitis","2026-08-19",{"date":32,"type":35},{"date":173,"type":35},"2026-06-29",{"date":175,"type":22},"2030-12-31",{"name":41,"class":42},17,{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":18,"minAge":186,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":23,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},"100579098","phase-3-a-study-to-assess-the-efficacy-and-safety-of-induction-and-maintenance-therapy-with-afimkibart-ro7790121-in-participants-with-moderately-to-severely-active-crohns-disease-100579098","NCT06819878","A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease","A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease","SIBERITE-1","Inclusion Criteria:\n\n* Confirmed diagnosis of CD\n* Moderately to severely active CD\n* Bodyweight \\>= 40 kilogram (kg)\n* Demonstrated inadequate response, loss of response and\u002For intolerance to at least one protocol-specified conventional or advanced CD therapy\n* Males and females of childbearing potential must meet protocol criteria for contraception requirements\n\nExclusion Criteria:\n\n* Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis\n* Participant with a history of \\>= 3 bowel resections (\\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)\n* Diagnosis of short gut or short bowel syndrome\n* Presence of an ileostomy, colostomy or ileoanal pouch\n* Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon\n* Presence of abdominal or perianal abscess\n* Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \\>3 openings\n* Current diagnosis or suspicion of primary sclerosing cholangitis\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study\n* Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia\n* History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancer\n* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) during screening\n* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB\n* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy","16 Years","80 Years",{"count":189,"type":22},600,[120],"This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).",[193],"Moderately to Severely Active Crohns Disease","2026-08-18",{"date":32,"type":35},{"date":197,"type":35},"2025-03-17",{"date":199,"type":22},"2033-12-31",{"name":41,"class":42},373,{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":107},"100641325","phase-1-a-study-to-investigate-the-safety-tolerability-and-pharmacokinetics-of-ro7663498-following-intravitreal-administration-in-participants-with-diabetic-retinopathy-100641325","NCT07588100","A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic Retinopathy","A Multicenter, Non-Randomized, Open-Label, Multiple-Ascending-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic Retinopathy","CENOTE","Inclusion Criteria:\n\nGeneral Inclusion Criteria\n\n* Diagnosis of Diabetes Mellitus (DM) (Type 1 or Type 2), as defined by the World Health Organization and\u002For American Diabetes Association\n\nOcular Inclusion Criteria for the Study Eye\n\n* BCVA score at screening of \\>= 19 letters in study eye using Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity testing charts\n* Non-proliferative diabetic retinopathy (NPDR) as assessed by the investigator and confirmed by the Central reading center (CRC)\n* Collection of \\>= 90 micro liter (μL) AH deemed feasible and safe by the investigator.\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria:\n\n* Any known hypersensitivity to any of the following compounds: fluorescein; any dilating, anesthetic, or povidone iodine eye drops; or any excipients contained in the treatments used in this study.\n* History of hypersensitivity to biologic agents, the investigational drug, or any of the excipients contained in the formulation administered IVT or systemically.\n\nOcular Exclusion Criteria for the Study Eye\n\n* Center-involved Diabetic Macular Edema (DME)\n* Any history or concurrent ocular conditions\u002Fprocedures and\u002For visual system conditions of the below.\n* Vitreoretinal surgery\u002Fpars plana vitrectomy.\n* Any history of glaucoma surgery or planned glaucoma surgery during the study.\n* Uncontrolled glaucoma\n* Anterior segment neovascularization.\n* Vitreous or preretinal hemorrhage.\n* Any ocular disease other than DR and DME that may Confound assessment of the retina in the opinion of the investigator or Confound development of worsening DR, DME, or retinal nonperfusion.\n* Any presence of active intraocular inflammation on Day 1 (i.e., Standardization of Uveitis Nomenclature \\[SUN\\] criteria \\> 0 or National Eye Institute \\[NEI\\] vitreous haze grading \\> 0) or any history of IOI.\n* Aphakia or previous violation of the posterior capsule in the study eye\n\nOcular Exclusion Criteria for the Non-study Eye\n\n* BCVA \\\u003C 38 letters",{"count":21,"type":22},[97],"This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants with diabetic retinopathy (DR).",[214],"Diabetic Retinopathy","2026-08-14",{"date":217,"type":35},"2026-08-17",{"date":219,"type":35},"2026-06-18",{"date":221,"type":22},"2027-12-30",{"name":41,"class":42},{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":23,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":244},"100635688","phase-3-cevostamab-in-combination-with-pomalidomide-and-dexamethasone-versus-standard-of-care-in-participants-with-previously-treated-multiple-myeloma-100635688","NCT07555938","Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma","A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Patients With Multiple Myeloma Who Have Received One to Three Prior Lines of Therapy","CEVOLUTION","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening and immediately prior to start of administration of study treatment.\n* Individuals with ECOG Performance Status of 2 solely due to local symptoms of myeloma (e.g., pain) are eligible\n* MM diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria\n* Received one to three lines of prior therapy that included at least two consecutive cycles of either of the following: A regimen containing an anti-CD38 therapy, a regimen containing lenalidomide\n* Participants must have measurable disease during screening\n\nExclusion Criteria:\n\n* Known history of amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy or documented within serum amyloid P component scan)\n* Plasma cell leukemia or circulating plasma cell count exceeding 500 cells\u002Fliter (L) or 5% of the peripheral blood white cells\n* GI disease that might significantly alter absorption of oral drugs\n* Participants must not have any ongoing CNS disease or non-secretory myeloma",{"count":232,"type":22},380,[120],"The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) versus standard of care (SOC) in participants with multiple myeloma (MM) who have received one to three prior lines of therapy and have been exposed to an anti-CD38 monoclonal antibody (mAb) and lenalidomide.",[236],"Multiple Myeloma","2026-08-13",{"date":215,"type":35},{"date":240,"type":35},"2026-06-23",{"date":242,"type":22},"2033-01-31",{"name":41,"class":42},40,{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":23,"phases":255,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":266},"100619933","phase-3-a-clinical-study-to-evaluate-the-effects-of-enicepatide-ro7795068-in-participants-with-obesity-or-overweight-and-type-2-diabetes-100619933","NCT07351058","A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes","A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight and Type 2 Diabetes","Enith2","Inclusion Criteria:\n\n* Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)\n* Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet\u002Fexercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.\n* Body mass index (BMI) ≥27.0 kg\u002Fm\\^2\n* History of ≥1 self-reported unsuccessful diet\u002Fexercise effort to lose body weight\n\nExclusion Criteria:\n\n* History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state\u002Fcoma within 12 months prior to screening\n* Have had 1 or more episodes of severe hypoglycemia and\u002For has hypoglycemia unawareness within the 6 months prior to screening\n* At least 2 confirmed fasting blood glucose values \\>270 mg\u002FdL (15.0 mmol\u002FL) (on 2 non-consecutive days) during screening\n* Self-reported change in body weight \\>5 kg within 3 months prior to screening\n* Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)\n* Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.\n* Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)\n* Poorly controlled hypertension at screening\n* Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)\u002Ftransient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure\n* Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1\u002FGIP receptor dual agonist, GLP-1\u002FGIP\u002FGluc receptor triple agonist) within 6 months prior to randomization",{"count":254,"type":22},1600,[120],"The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)\u002Fglucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).",[258,259],"Obesity or Overweight","Type 2 Diabetes Mellitus",{"date":215,"type":35},{"date":262,"type":35},"2026-03-23",{"date":264,"type":22},"2028-08-07",{"name":41,"class":42},193,{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":23,"phases":276,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":285},"100619932","phase-3-a-clinical-study-to-evaluate-the-effects-of-enicepatide-ro7795068-in-participants-with-obesity-or-overweight-without-type-2-diabetes-100619932","NCT07351045","A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes","A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight Without Type 2 Diabetes","Enith1","Inclusion Criteria:\n\n* Participants must have at screening:\n\n  1. Body mass index (BMI) greater than or equal to (≥)30.0 kg\u002Fm\\^2; or\n  2. BMI ≥27.0 kg\u002Fm\\^2 and \\\u003C30.0 kg\u002Fm\\^2 with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease\n* History of ≥1 self-reported unsuccessful diet\u002Fexercise effort to lose body weight\n* Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)\n\nExclusion Criteria:\n\n* History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state\u002Fcoma. Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since.\n* Self-reported change in body weight \\>5 kg within 3 months prior to screening\n* Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)\n* Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.\n* Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)\n* History of acute or chronic pancreatitis or clinically significant gallbladder disease. History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had a cholecystectomy to resolve the problem at least 3 months prior to screening.\n* Poorly controlled hypertension at screening\n* Any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)\u002Ftransient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure.\n* Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder). Participants with MDD or generalized anxiety disorder whose disease state is considered stable within 1 year prior to screening and expected to remain stable throughout the course of the study, in the opinion of the investigator, are allowed provided that they are not receiving prohibited medication.\n* Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1\u002FGIP receptor dual agonist, GLP-1\u002FGIP\u002FGluc receptor triple agonist) within 6 months prior to randomization",{"count":73,"type":22},[120],"The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon like peptide-1 (GLP-1)\u002Fglucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.",[258],{"date":215,"type":35},{"date":281,"type":35},"2026-03-16",{"date":283,"type":22},"2028-08-28",{"name":41,"class":42},195,{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":304},"100614786","a-study-to-evaluate-patient-reported-satisfaction-effectiveness-and-safety-of-atezolizumab-in-participants-treated-in-routine-clinical-practice-100614786","NCT07284121","A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice","A Non-Interventional, Multicenter, Multicohort Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Subcutaneous Atezolizumab in Participants Treated in Routine Clinical Practice","Inclusion Criteria:\n\n* Participants must have one of the following confirmed diagnoses for which atezolizumab is approved in the local SmPC:\n\n  * Early stage NSCLC following complete resection and platinum-based chemotherapy with a high risk of recurrence and PD-L1 expression on ≥ 50% of TC and with no EGFR-mutant or ALK-positive NSCLC\n  * Metastatic stage NSCLC with PD-L1 expression on ≥ 50% TC or ≥ 10% tumor infiltrating immune cells (IC) and with no EGFR-mutant or ALK-positive NSCLC not previously treated\n  * Extensive-stage small cell lung cancer (ES-SCLC) not previously treated\n  * Advanced or unresectable HCC not previously treated with systemic therapy\n* Should not have received \\> 4 prior cycles of IV Atezolizumab\n\nExclusion Criteria:\n\n* Not receiving treatment with Atezolizumab according to standard of care and in line with the current SmPC or local labelling\n* Receiving concomitant systemic anticancer therapy at the time of initiation of Atezolizumab or an Atezolizumab-containing regimen for treatment of the same disease, as per label\n* Receiving treatment with Atezolizumab as part of a clinical trial, pre-approval access program, compassionate use program, expanded use program, post-trial access program, or continued access program\n* Unwilling to complete questionnaires related to treatment satisfaction and treatment-related quality of life",{"count":294,"type":22},700,"This is a non-interventional, multi-country, multi-centre, multicohort, primary data collection study, designed to assess patients' reported satisfaction with Atezolizumab Subcutenous (SC) treatment and Health-related Quality of Life (HRQoL), as well as the effectiveness and safety of Atezolizumab SC in participants treated for selected approved indications in routine clinical practice.",[297],"Lung Cancer, Hepatocellular Carcinoma",{"date":217,"type":35},{"date":300,"type":35},"2025-07-15",{"date":302,"type":22},"2028-12-31",{"name":41,"class":42},91,{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":164,"enrollmentInfo":313,"targetDuration":4,"studyType":23,"phases":315,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":325},"100614667","phase-2-a-study-to-evaluate-the-safety-pharmacokinetics-pharmacodynamics-and-efficacy-of-ro7268489-as-add-on-therapy-to-ocrelizumab-in-participants-with-progressive-forms-of-multiple-sclerosis-ms-100614667","NCT07282574","A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489 as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis (MS)","A Multi-center, Double-blind, Placebo-controlled, Phase II Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489, a Monoacylglycerol Lipase Inhibitor, as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis","Mintaka","Inclusion Criteria:\n\n* PMS, in accordance with the revised 2017 McDonald criteria\n* Expanded disability status scale (EDSS) at screening between 3.0 and 6.0 inclusive\n\nExclusion Criteria:\n\n* MS relapse during the 6 months preceding the randomization date\n* Lack of peripheral venous access\n* History of alcohol or other drug abuse, in the opinion of the investigator, within 5 years prior to screening\n* Inability to complete an magnetic resonance imaging (MRI)\n* Contraindications to ocrelizumab mandatory pre-medications\n* Treatment with intravenous immunoglobulin (IV Ig) or plasmapheresis within 12 weeks prior to screening",{"count":314,"type":22},360,[25],"The main purpose of this study is to assess the efficacy of RO7268489 in adults with progressive multiple sclerosis (PMS) receiving ocrelizumab. After the end of the double-blind period, an open-label (OL) extension may allow eligible participants to receive open-label RO7268489.",[318],"Progressive Multiple Sclerosis",{"date":217,"type":35},{"date":321,"type":35},"2026-03-10",{"date":323,"type":22},"2030-05-30",{"name":41,"class":42},108,{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":23,"phases":335,"briefSummary":336,"conditions":337,"keywords":339,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":369},"100578033","phase-2-a-study-to-evaluate-the-optimization-of-the-cytokine-release-syndrome-profile-for-glofitamab-in-combination-with-gemcitabine-plus-oxaliplatin-in-participants-with-relapsedrefractory-aggressive-b-cell-non-hodgkins-lymphoma-100578033","NCT06806033","A Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed\u002FRefractory Aggressive B-Cell Non-Hodgkin's Lymphoma","A Phase II, Open-Label, Multicenter Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Patients With Relapsed\u002FRefractory Aggressive B-Cell Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed large B-cell lymphoma (de novo or transformed from FL) with one of the following diagnoses according to World Health Organization, fifth edition: DLBCL Not Otherwise Specified (NOS); High-Grade B-Cell Lymphoma (HGBL), NOS; DLBCL\u002FHGBL with MYC and BCL2 rearrangements\n* R\u002FR disease, defined as: relapsed = disease that has recurred following a response that lasted \\>\u002F= 6 months after completion of the last line of therapy; refractory = disease that did not respond to or that progressed \\\u003C 6 months after completion of the last line of therapy\n* At least one line of prior systemic therapy\n* Participants who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)\n* At least one bi-dimensionally measurable (\\> 1.5 cm) nodal lesion, or one bi-dimensionally measurable (\\> 1 cm) extranodal lesion, as measured on CT scan\n* Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2\n* According to the investigator's judgment, participants should be able to receive the step-up dose regimen in an outpatient setting\n* Adequate hematologic and renal function\n\nExclusion Criteria:\n\n* Prior enrollment in Studies GO41943 (NCT04313608), GO41944 (STARGLO; NCT04408638), or Study GO44900 (NCT06624085)\n* Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation\n* Any history of Waldenstrom's macroglobulinemia\n* Primary mediastinal B-cell lymphoma\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products\n* Contraindication to obinutuzumab, gemcitabine or oxaliplatin, or tocilizumab\n* Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3\n* Prior treatment with gemcitabine or oxaliplatin\n* Peripheral neuropathy or paresthesia assessed to be Grade \\>\u002F= 2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 at enrollment\n* Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment\n* Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment\n* Primary or secondary CNS lymphoma at the time of recruitment\n* Prior CNS involvement that has been definitively treated and confirmed via magnetic resonance imaging (MRI) or cerebrospinal fluid analysis to be in complete remission is permissible\n* Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n* History of other primary malignancy, with exceptions defined by the protocol\n* Significant or extensive cardiovascular disease\n* Significant pulmonary disease (including moderate or severe obstructive pulmonary disease)\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator) within 4 weeks prior to the first study treatment\n* Positive for: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); tuberculosis; hepatitis B virus (HBV); hepatitis C virus (HCV); chronic active Epstein-Barr viral infection\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) or progressive multifocal leukoencephalopathy\n* Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better (with the exception of alopecia and anorexia)\n* Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study\n* Prior solid organ transplantation or prior allogenic stem cell transplant\n* Active autoimmune disease requiring treatment\n* Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents), within 4 weeks prior to first dose of study treatment\n* Ongoing systemic corticosteroid use which, in the opinion of the investigator, puts the participant at increased risk of steroid-related iatrogenic adrenal insufficiency\n* Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis\n* Clinically significant history of cirrhotic liver disease\n* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high-risk from treatment complications\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 18 months after the final dose of study treatment",{"count":334,"type":22},100,[25],"This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) in participants with relapsed or refractory aggressive B-cell Non-Hodgkin's lymphoma. The study utilizes an optimized steroid premedication regimen and monitoring schedule specifically designed to enable the administration of the treatment regimen in an outpatient setting.",[338],"B-Cell Non-Hodgkins Lymphoma",[340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362],"Phase 2","Outpatient study","Open-label","Glofitamab","Gemcitabine","Oxaliplatin","Obinutuzumab","GemOx","Glofit-GemOx","Bispecific antibody","Aggressive B-cell Non-Hodgkin's lymphoma","Diffuse Large B-Cell Lymphoma (DLBCL)","DLBCL NOS (Not Otherwise Specified)","High-Grade B-Cell Lymphoma (HGBL)","HGBL NOS","Transformed follicular lymphoma","DLBCL\u002FHGBL with MYC and BCL2 rearrangements","Double-hit lymphoma","Relapsed or Refractory (R\u002FR)","Non-Hodgkin Lymphoma (NHL)","Cytokine Release Syndrome (CRS)","CRS optimization","Step-up dosing",{"date":215,"type":35},{"date":365,"type":35},"2025-03-05",{"date":367,"type":22},"2029-03-30",{"name":41,"class":42},53,{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":23,"phases":379,"briefSummary":380,"conditions":381,"keywords":383,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":385,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":391},"100433830","phase-1-a-study-evaluating-the-safety-and-efficacy-of-targeted-therapies-in-subpopulations-of-patients-with-metastatic-colorectal-cancer-intrinsic-100433830","NCT04929223","A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)","A Phase I\u002FIb Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)","Inclusion Criteria\n\n* Signed cohort-specific Informed Consent Form\n* Age \\>= 18 years at time of signing Informed Consent Form\n* Biomarker eligibility as determined by:\n\n  * A validated test approved by local health authorities for detection of the specified biomarkers\u002Fmutations.\n  * A validated test performed at a College of American Pathologists\u002Fclinical laboratory improvement amendments (CAP\u002FCLIA) -certified or equivalently accredited diagnostic laboratory using a validated test for detection of the specified biomarkers.\n  * Prior test results completed before signing cohort-specific Informed Consent Form or local test results generated prior to or during screening, and availability of a full report of the testing results OR\n  * Blood-based FoundationOne Liquid CDx biomarker eligibility test result generated prior to or during screening or, in case of re-enrollment after treatment discontinuation, prior to starting a new anti-cancer therapy.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of \\\u003C= 1\n* Life expectancy \\>= 3 months, as determined by the investigator\n* Histologically confirmed adenocarcinoma originating from the colon or rectum\n* Metastatic disease\n* Prior therapies for metastatic disease\n* Ability to comply with the study protocol, in the investigators judgment\n* Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)\n* Baseline tumor tissue samples will be collected from all participants for exploratory biomarker research\n* Adequate hematologic and organ function within 14 days prior to initiation of study treatment\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures\n* For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm\n\nExclusion Criteria\n\n* Current participation or enrollment in another interventional clinical trial. Participants who are participating in the follow-up period of an interventional clinical trial are eligible for the study.\n* Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study treatment\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Pregnant or breastfeeding, or intending to become pregnant during the study\n* History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or confounds the ability to interpret data from the study\n* Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety\n* Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n* Uncontrolled tumor-related pain\n* Uncontrolled or symptomatic hypercalcemia\n* Clinically significant and active liver disease\n* Negative HIV test at screening, with the following exception: Participants with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count greater than or equal to 200\u002FuL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.\n* Symptomatic, untreated, or actively progressing CNS metastases\n* History of leptomeningeal disease or carcinomatous meningitis\n* History of malignancy other than CRC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death\n* Any other disease, unresolved toxicity from prior therapy, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications\n* Requirement for treatment with any medicinal product that contraindicates the use of any of the study treatments, may interfere with the planned treatment, affects participant compliance, or puts the patient at higher risk for treatment-related complications",{"count":378,"type":22},542,[97],"This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.",[382],"Metastatic Colorectal Cancer",[384],"KRAS G12C",{"date":217,"type":35},{"date":387,"type":35},"2021-10-22",{"date":389,"type":22},"2030-08-31",{"name":41,"class":42},84,{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":23,"phases":401,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":414},"100644599","phase-3-a-study-to-evaluate-the-effects-of-enicepatide-in-participants-with-obesity-or-overweight-with-or-without-type-2-diabetes-100644599","NCT07670416","A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 in Adult Chinese Patients With Obesity or Overweight, With or Without Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* Body mass index (BMI) ≥24.0 kilograms per meter squared (kg\u002Fm\\^2) for participants with type 2 diabetes mellitus (T2DM)\n* BMI ≥28.0 kg\u002Fm\\^2 or BMI ≥24.0 and \\\u003C28.0 kg\u002Fm\\^2 and diagnosed with at least one weight-related comorbidity (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, or weight-related cardiovascular disease) for participants without T2DM\n* Agreement to adhere to the contraception requirements\n\nExclusion Criteria:\n\n* History of Type 1 diabetes mellitus (T1DM)\n* Obesity induced by other endocrinologic disorders\n* Any planned major medical procedure or surgery during the study\n* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder\n* Any lifetime history of suicide attempt\n* History of any hematologic conditions that may interfere with HbA1c measurement\n* History of acute or chronic pancreatitis or clinically significant gallbladder disease\n* Treatment with any approved or investigational GLP-1-RA-based therapy within 6 months prior to randomization\n* Treatment with other investigational therapy within 3 months prior to randomization or less than 5 elimination half-lives prior to randomization, whichever is longer\n* Known allergy to any component of the study drug formulation or any other condition that is a contraindication to GLP-1 RAs or GLP-1\u002FGIP RAs",{"count":400,"type":22},300,[120],"The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)\u002Fglucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.",[404,405,406],"Obesity","Overweight","Type 2 Diabetes Mellitus (T2DM)","2026-08-12",{"date":237,"type":35},{"date":410,"type":35},"2026-07-03",{"date":412,"type":22},"2028-03-15",{"name":41,"class":42},18,{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":18,"minAge":423,"maxAge":424,"enrollmentInfo":425,"targetDuration":4,"studyType":23,"phases":426,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":430,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":436},"100605109","phase-3-a-study-to-evaluate-the-pharmacokinetics-safety-and-efficacy-of-afimkibart-ro7790121-in-children-with-moderately-to-severely-active-ulcerative-colitis-100605109","NCT07158242","A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis","A Phase III Randomized Double-Blind Multi-Center Treat-Through Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Children Aged 2 - 17 Years With Moderately to Severely Active Ulcerative Colitis","AMETRINE-PEDS","Inclusion Criteria:\n\n* Bodyweight \\>= 10 kilogram (kg)\n* Confirmed diagnosis of UC\n* Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: systemic corticosteroids, immunomodulators, and\u002For biologic therapies as outlined in the protocol\n\nExclusion Criteria:\n\n* Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD)\n* Current diagnosis of Crohn's disease (CD), abdominal\u002Fintrabdominal\u002Fperianal fistula and\u002For abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease\n* Presence of an ostomy or ileoanal pouch\n* Current diagnosis or suspicion of primary sclerosing cholangitis\n* Any major surgery within 6 weeks prior to screening or a major planned surgery during the study\n* Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and\u002For chest imaging (X-ray or CT)","2 Years","17 Years",{"count":334,"type":22},[120],"This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).",[429],"Moderately to Severely Active Ulcerative Colitis",{"date":215,"type":35},{"date":432,"type":35},"2026-04-15",{"date":434,"type":22},"2031-03-31",{"name":41,"class":42},22,{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":456},"100576043","a-study-to-investigate-effects-of-ocrelizumab-treatment-on-neurofilament-light-chain-nfl-levels-and-participant-satisfaction-in-participants-with-multiple-sclerosis-ms-100576043","NCT06780150","A Study to Investigate Effects of Ocrelizumab Treatment on Neurofilament Light Chain (NfL) Levels and Participant Satisfaction in Participants With Multiple Sclerosis (MS)","SurfSubQ - A Prospective Longitudinal Multicenter Observational Study to Investigate Neurofilament Light Chain Levels and Patient Satisfaction After Subcutaneous Ocrelizumab Administration in Persons With Multiple Sclerosis","SurfSubQ","Inclusion Criteria:\n\n* Diagnosis of MS\n* RMS and PPMS participants diagnosed according to the McDonald criteria of 2017 or revised McDonald criteria 2024\n* First treatment during the course of MS therapy with ocrelizumab SC according to the local prescribing information, regardless of the reason for starting treatment with ocrelizumab\n\nExclusion Criteria:\n\n* Participation in interventional studies investigating DMTs for MS\n* Prior or simultaneous participation in CONFIDENCE or MoOzaRt (ISRCTN55332718) non interventional study (NIS) at the same study site\n* Prior treatment with rituximab (MabThera®) or ublituximab (Briumvi®)\n* Severe psychiatric disability\n* Pregnant women",{"count":446,"type":22},842,"The main purpose of the study is to evaluate participant satisfaction after administration of ocrelizumab subcutaneously (SC) after 12 months using the therapy administration satisfaction questionnaire subcutaneous (TASQ-SC).",[449],"Multiple Sclerosis",{"date":237,"type":35},{"date":452,"type":35},"2024-09-26",{"date":454,"type":22},"2028-03-31",{"name":41,"class":42},92,{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":23,"phases":467,"briefSummary":468,"conditions":469,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":477},"100402792","phase-1-a-study-evaluating-the-efficacy-and-safety-of-multiple-immunotherapy-based-treatment-combinations-in-patients-with-advanced-liver-cancers-morpheus-liver-100402792","NCT04524871","A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)","A Phase Ib\u002FII, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)","MORPHEUS-LIVER","Inclusion Criteria:\n\nStage 1\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization\n* Locally advanced or metastatic and\u002For unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology\u002Fcytology or clinically by American Association for the Study of\n* Liver Diseases criteria in cirrhotic patients\n* Child-Pugh class A within 7 days prior to randomization\n* Disease that is not amenable to curative surgical and\u002For locoregional therapies\n* No prior systemic treatment for HCC\n* Life expectancy \\>= 3 months\n* Availability of a representative tumor specimen that is suitable for determination of PD-L1 and\u002For additional biomarker status via central testing\n\nStage 1 and Stage 2\n\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1\n* Adequate hematologic and end-organ function within 7 days prior to initiation of study treatment\n* Documented virology status of hepatitis, as confirmed by screening tests for hepatitis B virus - (HBV) and hepatitis C virus (HCV)\n* Negative HIV test at screening\n* For women of childbearing potential: agreement to remain abstinent or use contraception and for men: agreement to remain abstinent or use contraception, and agreement to refrain from donating sperm\n\nStage 2\n\n* ECOG Performance Status of 0, 1, or 2\n* Ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity not related to atezolizumab or RO7247669 or loss of clinical benefit as determined by the investigator while receiving Stage 1 treatment\n* Availability of a tumor specimen from a biopsy performed upon discontinuation of Stage 1 (if deemed clinically feasible)\n\nNKT2152-Containing Arm:\n\n* Total bilirubin ≤ 1.5 X ULN in the absence of Gilbert's disease (≤ 3.0 X ULN if Gilbert's disease)\n* AST\u002FALT ≤ 2.5 X ULN (≤ 5 X ULN if liver metastases present)\n\nExclusion Criteria:\n\nStage 1\n\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies or inhibitors targeting HIF2a\n* Treatment with investigational therapy within 28 days prior to initiation of study\n* Treatment with locoregional therapy to liver within 28 days prior to initiation of study, or non-recovery from side effects of any such procedure\n* Untreated or incompletely treated esophageal and\u002For gastric varices with bleeding or at high risk for bleeding\n* Prior bleeding event due to esophageal and\u002For gastric varices within 6 months prior to initiation of study\n* AEs from prior anti-cancer therapy that have not resolved to Grade \\\u003C= 1 or better, with the exception of alopecia of any grade\n* Inadequately controlled hypertension\n* History of hypertensive crisis or hypertensive encephalopathy\n* Significant vascular disease\n* History of hemoptysis within 1 month prior to initiation of study\n* Evidence of bleeding diathesis or significant coagulopathy\n* Current or recent use of aspirin (\\>325 mg\u002Fday) or treatment with clopidogrel, dipyramidole, ticlopidine, or cilostazol\n* Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose\n* Core biopsy or other minor surgical procedure within 3 days prior to initiation of study\n* History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess, intestinal obstruction and\u002For clinical signs\u002Fsymptoms of GI obstruction\n* Evidence of abdominal free air not explained by paracentesis or recent surgery\n* Serious, non-healing\u002Fdehiscing wound, active ulcer, or untreated bone fracture\n* Grade \\>=2 proteinuria\n* Metastatic disease involving major airways\u002Fblood vessels, or centrally located mediastinal tumor masses of large volume\n* History of clinically significant intra-abdominal inflammatory process\n* Radiotherapy within 28 days or abdominal\u002Fpelvic radiotherapy within 60 days prior to initiation of study with the exception of palliative radiotherapy to bone lesions within 7 days prior to initiation of study\n* Major surgery, open biopsy, or significant traumatic injury within 28 days prior to initiation of study; or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to initiation of study; or anticipation of need for major surgery during study or non-recovery from side effects of any such procedure\n* Chronic daily treatment with NSAID\n* Eligible only for control arm\n\nStage 1 and 2\n\n* Fibrolamellar or sarcomatoid HCC, or mixed cholangiocarcinoma and HCC\n* History of hepatic encephalopathy\n* Moderate or severe ascites\n* HBV and HCV coinfection\n* Symptomatic, untreated, or actively progressing CNS metastases\n* History of leptomeningeal disease\n* Uncontrolled tumor-related pain\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\n* Uncontrolled or symptomatic hypercalcemia\n* Active or history of autoimmune disease or immune deficiency\n* History of IPF, organizing pneumonia, drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan\n* Active TB\n* Significant CV disease within 3 months prior to initiation of study, unstable arrhythmia, or unstable angina\n* Major surgery, other than for diagnosis, within 4 weeks prior to initiation of study, or anticipated major surgery during study\n* History of malignancy other than HCC within 5 years prior to screening\n* Severe infection within 4 weeks prior to initiation of study\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study\n* Prior allogeneic stem cell or solid organ transplantation\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known allergy or hypersensitivity to any of the study drugs or any of their excipients\n* Treatment with systemic immunostimulatory, immunosuppressive agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study\n* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study\n* Grade \\>= 3 hemorrhage or bleeding event within 8 weeks prior to initiation of study treatment\n* Patients entering Stage 2: immunotherapy-related adverse events that have not resolved to Grade 1 or better or to baseline at time of consent",{"count":466,"type":22},518,[97,25],"This is a Phase Ib\u002FII, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer.\n\nCohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.",[470],"Advanced Liver Cancers",{"date":215,"type":35},{"date":473,"type":35},"2020-11-01",{"date":475,"type":22},"2027-09-30",{"name":41,"class":42},33,{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":485,"enrollmentInfo":486,"targetDuration":4,"studyType":23,"phases":488,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":498},"100493377","phase-1-a-study-to-investigate-the-safety-tolerability-and-processing-by-the-body-of-intravenous-and-subcutaneous-ro7121932-administration-in-participants-with-multiple-sclerosis-100493377","NCT05704361","A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis","A Multiple-center, Non-randomized, Open-label, Adaptive, Single-ascending Dose (Part 1 and Part 2) and Multiple-ascending Dose (Part 3), and Long-term Safety (Part 4), Parallel, Phase IB Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of RO7121932 Following Intravenous (Parts 1 and 4) and Subcutaneous (Parts 2, 3 and 4) Administration in Participants With Multiple Sclerosis","Inclusion Criteria:\n\n* Expanded Disability Status Scale (EDSS) score ≤7.0 at Screening\n* Participants with relapsing multiple sclerosis (RMS) or progressive multiple sclerosis (PMS) who fulfil international panel criteria for diagnosis (McDonald 2017 criteria)\n* Participants not treated with any approved MS treatment at Screening and not planning to start on any MS therapy during the study (including follow-up)\n* Biological male and female participants\n* Female participants must practice abstinence or otherwise use contraception\n\nExclusion Criteria:\n\n* Evidence of clinical disease activity as defined by any clinical relapse within 3 months prior to screening, or by \\>1 clinical relapse within 12 months prior to screening\n* Evidence of brain magnetic resonance imaging (MRI) activity as defined by the presence of ≥ 1 Gadolinium (Gd)-enhancing T1 lesion in the screening MRI scan or by ≥ 4 new or enlarging T2 lesions in the screening scan as compared to a reference scan\n* Participants who have active progressive multifocal leukoencephalopathy (PML), have had confirmed PML, or have a high degree of suspicion for PML\n* Known presence of other neurological disorders that may mimic MS including but not limited to: neuromyelitis optica spectrum disease, Lyme disease, untreated Vitamin B12 deficiency, neurosarcoidosis, cerebrovascular disorders, and untreated hypothyroidism\n* Known active or uncontrolled bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds, including participants exhibiting symptoms consistent with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 6 weeks prior to Day 1\n* Participants with a current diagnosis of epilepsy\n* Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, gastrointestinal or other major diseases\n* History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening. Basal or squamous cell carcinoma of the skin that has been excised and is considered cured and in situ carcinoma of the cervix treated with apparent success by curative therapy \\>1 year prior to screening is not exclusionary\n* History of inflammatory bowel disease or other clinically significant gastrointestinal disorders\n* Any concomitant disease that may require treatment with systemic corticosteroids or immunosuppressants during course of the study\n* History of currently active primary or secondary (non-drug-related) immunodeficiency\n* History of hypersensitivity to biologic agents or any of the excipients in the formulation\n* Only for cohorts where CSF samples are planned to be collected: Participants with a history of spinal cord compression, raised intra-cerebral pressure, clinically significant vertebral joint pathology or any other current abnormalities in the lumbar region which could prevent the lumbar puncture procedure.\n\nPrior\u002FConcomitant Therapy:\n\n* Treatment with any approved MS treatment at Screening. Participants may become eligible after completion of a washout period prior to acquiring any screening laboratory tests but should not be withdrawn from therapies for the sole purpose of meeting eligibility for the trial\n* Previous treatment with RO7121932, alemtuzumab, cladribine, mitoxantrone, cyclophosphamide, total body irradiation, bone marrow transplantation, and hematopoietic stem cell transplantation. For the USA only, previous treatment with daclizumab\n* Previous treatment with anti-CD20 B-cell-depleting therapies (e.g., rituximab, ocrelizumab, or ofatumumab)\n\n  * \\\u003C12 months prior to acquiring any screening laboratory tests,\n  * ≥12 months prior to acquiring any screening laboratory tests, if B-cells are outside the normal range, or not back to individual baseline ± 20% (if data are available),\n  * If discontinuation of a prior B-cell depletion therapy was motivated by safety reasons\n* Current or prior treatment with natalizumab (if \\\u003C24 months prior to acquiring any screening laboratory tests)\n\nPrior\u002FConcurrent Clinical Study Experience:\n\n\\- Participation in an investigational drug medicinal product or medical device study within 30 days before Screening or within five times the pharmacodynamic (PD) or pharmacokinetic (PK) half-life (if known), whichever is longer\n\nDiagnostic Assessments:\n\n* Positive result on human immunodeficiency virus (HIV1) and HIV2, hepatitis C, or hepatitis B\n* Participants with SI or behavior within 6 months prior to Screening or participants who, in the Investigator's judgment, pose a suicidal or homicidal risk\n* Vaccination with a live or live-attenuated vaccine within 6 weeks prior to Day 1","65 Years",{"count":487,"type":22},119,[97],"The primary purpose of the study is to evaluate the safety and tolerability of a single-ascending intravenous (IV) dose (Part 1), a single-ascending subcutaneous (SC) dose (Part 2), and multiple ascending SC doses (Part 3), and multiple-ascending SC doses following a single IV dose (Part 4) of RO7121932 in participants with multiple sclerosis (MS). Only Parts 1 and 2 of the study will be conducted in the United States, whereas Parts 1, 2, 3, and 4 will be conducted in all other participating countries outside the United States.",[449],"2026-08-11",{"date":237,"type":35},{"date":494,"type":35},"2021-08-11",{"date":496,"type":22},"2027-07-08",{"name":41,"class":42},32,{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":23,"phases":509,"briefSummary":510,"conditions":511,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":513,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":519},"100318305","phase-1-a-study-evaluating-the-efficacy-and-safety-of-multiple-treatment-combinations-in-patients-with-metastatic-or-locally-advanced-breast-cancer-100318305","NCT03424005","A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer","A Phase Ib\u002FII, Open-label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic Breast Cancer (Morpheus-panBC)","Morpheus-panBC","Inclusion Criteria\n\nPatients must meet all of the following criteria to qualify for Stage 1 (all cohorts) and to qualify for Stage 2 (2L CIT-naïve cohort):\n\n* Age \\>\u002F= 18 years at the time of signing Informed Consent Form\n* Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n* Able to comply with the study protocol, in the investigator's judgment\n* Metastatic or inoperable locally advanced adenocarcinoma of the breast\n* Measurable disease (at least one target lesion) according to RECIST v1.1\n* Life expectancy \\>\u002F= 3 months, as determined by the investigator\n* Tumor accessible for biopsy, unless archival tissue is available\n* Availability of a representative tumor specimen that is suitable for biomarker analysis via central testing\n* Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from breastfeeding and donating eggs, as outlined for each specific treatment arm\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm\n\nExclusion Criteria\n\nExclusion Criteria for Stage 1\n\n* Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, CD40 agonists or interleukin-2 (IL-2) or IL-2-like compounds\n* Biologic treatment (e.g., bevacizumab) within 2 weeks prior to initiation of study treatment, or other systemic treatment for TNBC within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study\n* Eligibility only for the control arm\n\nExclusion Criteria for Stage 1 (both cohorts) and Stage 2 (2L CIT-naïve cohort)\n\n* Adverse events from prior anti-cancer therapy that have not resolved to Grade \\\u003C\u002F= 1 or better with the exception of alopecia of any grade and Grade \\\u003C\u002F= 2 peripheral neuropathy\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n* Uncontrolled tumor-related pain\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* History of leptomeningeal disease\n* Active or history of autoimmune disease or immune deficiency\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Active tuberculosis\n* Severe infection within 4 weeks prior to initiation of study treatment\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment\n* Significant cardiovascular disease\n* Prior allogeneic stem cell or solid organ transplantation\n* History of malignancy other than breast cancer within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study",{"count":508,"type":22},1132,[97,25],"This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer.\n\nThe study will be performed in two stages. During Stage 1, seven cohorts will be enrolled in parallel in this study:\n\nCohort 1 will consist of programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line \\[1L\\] PD-L1+ cohort).\n\nCohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line \\[2L\\] CIT-naïve cohort).\n\nCohort 3, 5, 6 and 7 will consist of participants with locally advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative disease with one or more PIK3CA mutations.\n\nCohort 4 will consist of participants with locally advanced or metastatic HER2+ \u002FHER2-low disease with one or more PIK3CA mutations who had disease progression on standard-of-care therapies (HER2+ \u002FHER2-low cohort).\n\nIn each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). During Stage 2, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination, provided Stage 2 is open for enrollment and all eligibility criteria are met.",[512],"Metastatic Breast Cancer",{"date":407,"type":35},{"date":515,"type":35},"2018-03-30",{"date":517,"type":22},"2030-09-30",{"name":41,"class":42},49,{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":526,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":18,"minAge":528,"maxAge":424,"enrollmentInfo":529,"targetDuration":4,"studyType":23,"phases":531,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":177},"100605341","phase-2-a-pharmacokinetics-pk-pharmacodynamics-pd-safety-and-tolerability-study-of-fenebrutinib-in-children-and-adolescents-with-relapsing-multiple-sclerosis-rms-100605341","NCT07161258","A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)","An Open-label, Single-arm Study to Evaluate Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis","FENerations1","Inclusion Criteria:\n\n* A diagnosis of RMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, and the revised 2017 McDonald Criteria and one or more of the following: at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of at least one Gd enhancing lesion on MRI within 6 month\n* Expanded Disability Status Scale (EDSS) at screening from 0 to 5.5 points, inclusive\n* Children and adolescents must have received all childhood vaccinations as per local\u002Fnational recommendations for childhood vaccination against infectious diseases\n\nExclusion Criteria:\n\n* A diagnosis of primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS)\n* Co-morbid Conditions:\n* Potentially confounding neurological, somatic, or metabolic disorders\n* Current clinically significant psychiatric or medical illness\n* History of cancer, transplants, or bleeding disorders\n* Inability to complete an MRI scan or get gadolinium\n* Abnormal liver function tests or blood counts\n* Sensitivity or intolerance to any ingredient (including excipients) of fenebrutinib tablets\n* Active, recurrent, or chronic infections\n* Recent or anticipated use of prohibited medications\u002Ftreatments:\n* Certain disease-modifying therapy (DMT) and other immunosuppressants\n* Drugs interacting with fenebrutinib (Cytochrome P450 3A4 \\[CYP3A4\\] inhibitors)\n* Any other investigational therapy, anticoagulants, certain vaccines\n* A score of 4 or 5 on the \"last 6 months\" section of the screening SI section or \"yes\" on any item of the \"last 6 months\" Suicidal Behavior (SB) section of the C-SSRS or a positive answer on Question 9 of the Patient Health Questionnaire-9 Modified for Adolecents (PHQ-A) or significant risk of suicide, in the investigator's judgment","10 Years",{"count":530,"type":22},12,[25],"This open label, single arm study will evaluate the PK and PD effects of fenebrutinib in children and adolescents with RMS aged between 10 and \\\u003C 18 years.\n\nThis study consists of a Dose Exploration Period and an Optional Extension Period. Eligible participants may choose to continue treatment with fenebrutinib in the optional extension period after completing the dose exploration period.",[534],"Relapsing Multiple Sclerosis",[536,537,538,539,540,541],"Pediatric multiple sclerosis","Pediatric MS","Children MS","Children multiple sclerosis","Adolescent multiple sclerosis","Pediatric fenebrutinib","2026-08-10",{"date":491,"type":35},{"date":545,"type":35},"2025-10-06",{"date":547,"type":22},"2029-02-13",{"name":41,"class":42},{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":18,"minAge":557,"maxAge":558,"enrollmentInfo":559,"targetDuration":4,"studyType":23,"phases":561,"briefSummary":563,"conditions":564,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":566,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":572},"100505485","phase-4-a-study-evaluating-the-effectiveness-and-safety-of-risdiplam-administered-in-pediatric-patients-with-spinal-muscular-atrophy-who-experienced-a-plateau-or-decline-in-function-after-gene-therapy-100505485","NCT05861999","A Study Evaluating the Effectiveness and Safety of Risdiplam Administered in Pediatric Patients With Spinal Muscular Atrophy Who Experienced a Plateau or Decline in Function After Gene Therapy","A Phase IV Open-Label Study Evaluating the Effectiveness and Safety of Risdiplam Administered in Pediatric Patients With Spinal Muscular Atrophy Who Experienced a Plateau or Decline in Function After Gene Therapy","HINALEA 2","Inclusion Criteria:\n\n* \\\u003C2 years of age at the time of informed consent\n* Confirmed diagnosis of 5q-autosomal recessive SMA, including genetic confirmation of homozygous deletion or compound heterozygosity predictive of loss of function of the Survival of Motor Neuron 1 (SMN1) gene\n* Confirmed presence of two SMN2 gene copies as documented through laboratory testing\n* Administration of onasemnogene abeparvovec pre-symptomatically or post-symptomatically\n* Has received onasemnogene abeparvovec for SMA no less than 13 weeks prior to enrollment\n* If treated with risdiplam prior to onasemnogene abeparvovec, risdiplam treatment must not have exceeded 3 weeks and must be discontinued 1 day prior to onasemnogene abeparvovec administration.\n* In the opinion of the investigator, has demonstrated a plateau or decline in function post-gene therapy (with a duration of 26 weeks or less) documented by 2 individual time points in the functions as follows: swallowing AND one additional function\u002Fability (respiratory, motor function, other) per appropriate expectation.\n\nExclusion Criteria:\n\n* Previous or current enrolment in investigational study prior to initiation of study treatment\n* Any unresolved standard-of-care laboratory abnormalities per the onasemnogene abeparvovec prescribing information\n* Concomitant or previous administration of an SMN2-targeting antisense oligonucleotide\n* Concomitant or previous use of an anti-myostatin agent\n* Participants requiring invasive ventilation or tracheostomy\n* Presence of feeding tube and an OrSAT score of 0\n* Hospitalization for pulmonary event within the last 2 months, or any planned hospitalization at the time of screening\n* Any major illness requiring hospitalization within 1 month before the screening examination or any febrile illness within 1 week prior to screening and up to first dose administration.","3 Months","24 Months",{"count":560,"type":22},28,[562],"PHASE4","This is an open-label, single-arm, multicenter clinical study to evaluate the effectiveness and safety of risdiplam administered in pediatric participants with SMA and 2 SMN2 copies who previously received onasemnogene abeparvovec and experience a plateau or decline in function. Participants to be enrolled are children \\\u003C2 years of age genetically diagnosed with SMA.",[565],"Muscular Atrophy, Spinal",{"date":491,"type":35},{"date":568,"type":35},"2024-08-14",{"date":570,"type":22},"2029-03-31",{"name":41,"class":42},19,{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":579,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":18,"minAge":423,"maxAge":581,"enrollmentInfo":582,"targetDuration":4,"studyType":23,"phases":584,"briefSummary":585,"conditions":586,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":589,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":595},"100454603","phase-3-a-study-to-evaluate-pharmacokinetics-efficacy-safety-tolerability-and-pharmacodynamics-of-satralizumab-in-pediatric-patients-with-aquaporin-4-antibody-positive-neuromyelitis-optica-spectrum-disorder-nmosd-100454603","NCT05199688","A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)","A Phase III, Multicenter, Open-Label, Uncontrolled Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)","SAkuraSun","Inclusion Criteria:\n\n* Age at screening 2-11 years, inclusive\n* Body weight at screening \\>=10 kg\n* For female patients of childbearing potential (postmenarchal): agreement to either remain completely abstinent (refrain from heterosexual intercourse) or to use a reliable means of contraception\n* Diagnosed as having NMOSD with AQP4 antibody seropositive status as defined by the Wingerchuk 2015 criteria Clinical evidence of at least one documented attack (including first attack) in the last year prior to screening\n* Neurological stability for \\>=30 days prior to both screening and baseline\n* Expanded Disability Status Scale (EDSS) 0 to 6.5\n* For patients receiving a baseline immunosuppressant treatment and planning to continue on these therapies, treatment must be at stable dose for 4 weeks prior to baseline\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Evidence of other demyelinating disease mimicking NMOSD\n* Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline\n* Evidence of chronic active hepatitis B or C\n* Evidence of untreated latent or active tuberculosis (TB)\n* Receipt of a live or live-attenuated vaccine within 6 weeks prior to baseline\n* History of severe allergic reaction to a biologic agent","11 Years",{"count":583,"type":22},8,[120],"This study will primarily evaluate the pharmacokinetics of satralizumab in pediatric patients aged 2-11 years with anti-aquaporin-4 (AQP4) antibody seropositive neuromyelitis optica spectrum disorder (NMOSD). Efficacy, safety, tolerability, and pharmacodynamics will be evaluated in a descriptive manner, given the small number of patients who will be enrolled in this study.",[587,588],"Neuromyelitis Optica Spectrum Disorder","NMOSD",{"date":491,"type":35},{"date":591,"type":35},"2026-05-06",{"date":593,"type":22},"2029-09-12",{"name":41,"class":42},13,""]