[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06408259":3,"trial-entities:NCT06408259":463,"trial-summary:NCT06408259":466},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":44,"secondary_outcomes":48,"sex":73,"minimum_age":74,"maximum_age":75,"healthy_volunteers":76,"eligibility_criteria":77,"std_ages":86,"locations":88,"central_contacts":445,"overall_officials":452,"references":455,"see_also_links":456},"NCT06408259","IM047-050","Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis","A Phase 3, Multicenter, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ozanimod Compared to Oral Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis","RECRUITING","2036-07-13","2026-04","2026-04-28","2025-04-08","Bristol-Myers Squibb","INDUSTRY",true,"The purpose of this study is to evaluate the effectiveness, safety, tolerability, drug levels and drug effects of ozanimod compared to fingolimod in children and adolescents with relapsing remitting multiple sclerosis (RRMS).",null,[19],"Multiple Sclerosis, Relapsing-Remitting",[21,22,23,24],"Multiple Sclerosis","Relapsing-Remitting","Ozanimod","Zeposia®","INTERVENTIONAL","TREATMENT",[28],"PHASE3",{"count":30,"type":31},194,"ESTIMATED",[33,37,40],{"type":34,"name":23,"description":35,"armGroupLabels":36},"DRUG","Specified dose on specified days",[23],{"type":34,"name":38,"description":35,"armGroupLabels":39},"Fingolimod",[38],{"type":41,"name":42,"description":35,"armGroupLabels":43},"OTHER","Placebo",[38,23],[45],{"measure":46,"timeFrame":47},"Annualized relapse rate (ARR)","Up to 2 years",[49,52,55,58,61,63,65,68,70],{"measure":50,"timeFrame":51},"Proportion of participants who did not have a confirmed relapse","At 12 and 24 months",{"measure":53,"timeFrame":54},"Number of gadolinium enhancing (GdE) T1 lesions","At month 6 and month 12",{"measure":56,"timeFrame":57},"Number of new or newly enlarging hyperintense lesions on T2 magnetic resonance imaging (MRI) sequences","At 6, 12, 18, and 24 months",{"measure":59,"timeFrame":60},"Incidence of treatment-emergent adverse events (TEAEs) over the treatment period and over the post-treatment follow-up period","Up to 87 months",{"measure":62,"timeFrame":60},"Incidence of adverse event of special interests (AESIs) over the treatment period and over the post-treatment follow-up period",{"measure":64,"timeFrame":60},"Adverse events (AEs) leading to discontinuation over the treatment period and over the post-treatment follow-up period",{"measure":66,"timeFrame":67},"Steady state plasma concentrations of ozanimod","At day 90",{"measure":69,"timeFrame":67},"Steady state plasma concentrations of the primary active metabolite CC112273",{"measure":71,"timeFrame":72},"Change from baseline pharmacodynamics (PD) biomarkers of absolute lymphocyte count","At day 90 and throughout the study up to 24 months","ALL","10 Years","17 Years",false,{"inclusion":78,"exclusion":81,"raw_text":85},[79,80],"Has a diagnosis of multiple sclerosis (MS) as defined by the 2017 revision of the McDonald Criteria with a relapsing remitting course of disease.","Meets at least 1 of the following criteria for disease activity:",[82,83,84],"Diagnosis of progressive forms of MS.","Active or chronic disease of the immune system other than MS.","Clinically relevant cardiovascular, hepatic, neurological other major systematic disease.","Inclusion Criteria:\n\n* Has a diagnosis of multiple sclerosis (MS) as defined by the 2017 revision of the McDonald Criteria with a relapsing remitting course of disease.\n* Meets at least 1 of the following criteria for disease activity:\n\n  i) At least 1 MS relapse\u002Fattack in the previous year prior to screening.\n\nii) At least 2 MS relapses\u002Fattacks in the previous 2 years prior to screening.\n\niii) Evidence of 1 or more gadolinium-enhancing (GdE) lesions on magnetic resonance imaging (MRI) within 6 months prior to baseline (including screening MRI).\n\n\\- Has an Expanded Disability Status Scale (EDSS) score of 0 to 5.5, both inclusive.\n\nExclusion Criteria:\n\n* Diagnosis of progressive forms of MS.\n* Active or chronic disease of the immune system other than MS.\n* Clinically relevant cardiovascular, hepatic, neurological other major systematic disease.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",[87],"CHILD",[89,103,114,126,135,143,155,166,173,181,192,203,215,228,241,253,260,272,281,294,306,317,328,335,346,358,366,378,390,401,411,421,433],{"facility":90,"status":91,"city":92,"state":93,"zip":94,"country":95,"contacts":96,"geoPoint":100},"Local Institution - 0114","NOT_YET_RECRUITING","Loma Linda","California","92354","United States",[97],{"name":98,"role":99},"Site 0114","CONTACT",{"lat":101,"lon":102},34.04835,-117.26115,{"facility":104,"status":8,"city":105,"state":93,"zip":106,"country":95,"contacts":107,"geoPoint":111},"University of California Davis Health","Sacramento","95817",[108],{"name":109,"role":99,"phone":110},"Frederick Bassal, Site 0130","916-734-3588",{"lat":112,"lon":113},38.58157,-121.4944,{"facility":115,"status":8,"city":116,"state":117,"zip":118,"country":95,"contacts":119,"geoPoint":123},"University of South Florida","Tampa","Florida","33612",[120],{"name":121,"role":99,"phone":122},"Natalie Moreo, Site 0053","813-396-9478",{"lat":124,"lon":125},27.94752,-82.45843,{"facility":127,"status":128,"city":129,"state":130,"zip":131,"country":95,"geoPoint":132},"Local Institution - 0093","WITHDRAWN","Chicago","Illinois","60611",{"lat":133,"lon":134},41.85003,-87.65005,{"facility":136,"status":8,"city":129,"state":130,"zip":137,"country":95,"contacts":138,"geoPoint":142},"University of Chicago Medical Center","60637",[139],{"name":140,"role":99,"phone":141},"Moon Hee Hur, Site 0055","773-702-6673",{"lat":133,"lon":134},{"facility":144,"status":8,"city":145,"state":146,"zip":147,"country":95,"contacts":148,"geoPoint":152},"University of Louisville, Norton Children's Research Institute","Louisville","Kentucky","40202",[149],{"name":150,"role":99,"phone":151},"Michael Sweeney, Site 0047","502-629-5606",{"lat":153,"lon":154},38.25424,-85.75941,{"facility":156,"status":91,"city":157,"state":158,"zip":159,"country":95,"contacts":160,"geoPoint":163},"Local Institution - 0131","New Brunswick","New Jersey","08901",[161],{"name":162,"role":99},"Site 0131",{"lat":164,"lon":165},40.48622,-74.45182,{"facility":167,"status":128,"city":168,"state":158,"zip":169,"country":95,"geoPoint":170},"Local Institution - 0132","Teaneck","07666",{"lat":171,"lon":172},40.8976,-74.01597,{"facility":174,"status":128,"city":175,"state":176,"zip":177,"country":95,"geoPoint":178},"Local Institution - 0091","Cincinnati","Ohio","45229",{"lat":179,"lon":180},39.12711,-84.51439,{"facility":182,"status":91,"city":183,"state":184,"zip":185,"country":95,"contacts":186,"geoPoint":189},"Local Institution - 0092","Portland","Oregon","97225",[187],{"name":188,"role":99},"Site 0092",{"lat":190,"lon":191},45.52345,-122.67621,{"facility":193,"status":91,"city":194,"state":195,"zip":196,"country":95,"contacts":197,"geoPoint":200},"Local Institution - 0133","El Paso","Texas","79912",[198],{"name":199,"role":99},"Site 0133",{"lat":201,"lon":202},31.75872,-106.48693,{"facility":204,"status":8,"city":205,"state":206,"zip":207,"country":95,"contacts":208,"geoPoint":212},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226",[209],{"name":210,"role":99,"phone":211},"Ahmed Obeidat, Site 0033","414-955-0619",{"lat":213,"lon":214},43.0389,-87.90647,{"facility":216,"status":8,"city":217,"state":218,"zip":219,"country":220,"contacts":221,"geoPoint":225},"Royal Children's Hospital","Melbourne","Victoria","3052","Australia",[222],{"name":223,"role":99,"phone":224},"Eppie Yiu, Site 0113","6139455661",{"lat":226,"lon":227},-37.814,144.96332,{"facility":229,"status":8,"city":230,"state":231,"zip":232,"country":233,"contacts":234,"geoPoint":238},"University of Naples Federico II","Naples","Campania","80131","Italy",[235],{"name":236,"role":99,"phone":237},"Vincenzo Brescia Morra, Site 0083","+39081743741",{"lat":239,"lon":240},40.85216,14.26811,{"facility":242,"status":8,"city":243,"state":244,"zip":245,"country":233,"contacts":246,"geoPoint":250},"Ospedale San Raffaele","Milan","Lombardy","20132",[247],{"name":248,"role":99,"phone":249},"Massimo Filippi, Site 0082","+390226433958",{"lat":251,"lon":252},45.46427,9.18951,{"facility":254,"status":91,"city":243,"state":244,"zip":255,"country":233,"contacts":256,"geoPoint":259},"Local Institution - 0081","20133",[257],{"name":258,"role":99},"Site 0081",{"lat":251,"lon":252},{"facility":261,"status":8,"city":262,"state":263,"zip":264,"country":233,"contacts":265,"geoPoint":269},"Neurological Center Of Latium","Rome","Roma","00178",[266],{"name":267,"role":99,"phone":268},"Carlo Pozzilli, Site 0086","06.3377.5441",{"lat":270,"lon":271},41.89193,12.51133,{"facility":273,"status":128,"city":274,"state":275,"zip":276,"country":277,"geoPoint":278},"Local Institution - 0078","Mexico City","DIF","04530","Mexico",{"lat":279,"lon":280},19.42847,-99.12766,{"facility":282,"status":8,"city":283,"state":284,"zip":285,"country":286,"contacts":287,"geoPoint":291},"Uniwersytecki Szpital Kliniczny w Poznaniu","Poznan","Greater Poland Voivodeship","60-355","Poland",[288],{"name":289,"role":99,"phone":290},"Barbara Steinborn, Site 0108","48618691255",{"lat":292,"lon":293},52.40692,16.92993,{"facility":295,"status":8,"city":296,"zip":297,"country":298,"contacts":299,"geoPoint":303},"2Ca Braga","Braga","4710-243","Portugal",[300],{"name":301,"role":99,"phone":302},"Joao Cerqueira, Site 0103","+351915301556",{"lat":304,"lon":305},41.5514,-8.42311,{"facility":307,"status":8,"city":308,"zip":309,"country":298,"contacts":310,"geoPoint":314},"Unidade Local de Saúde de Coimbra, E.P.E.","Coimbra","3000-602",[311],{"name":312,"role":99,"phone":313},"Filipe Palavra, Site 0105","+351914632128",{"lat":315,"lon":316},40.20686,-8.41996,{"facility":318,"status":8,"city":319,"zip":320,"country":298,"contacts":321,"geoPoint":325},"Centro Hospitalar de Lisboa Central","Lisbon","1169-050",[322],{"name":323,"role":99,"phone":324},"João Sequeira, Site 0104","00351912576085",{"lat":326,"lon":327},38.72509,-9.1498,{"facility":329,"status":128,"city":330,"zip":331,"country":298,"geoPoint":332},"Local Institution - 0102","Porto","4200-319",{"lat":333,"lon":334},41.1485,-8.61097,{"facility":336,"status":91,"city":337,"zip":338,"country":339,"contacts":340,"geoPoint":343},"Local Institution - 0134","Caguas","00725","Puerto Rico",[341],{"name":342,"role":99},"Site 0134",{"lat":344,"lon":345},18.23412,-66.0485,{"facility":347,"status":8,"city":348,"state":348,"zip":349,"country":350,"contacts":351,"geoPoint":355},"Spitalul Clinic de Copii Doctor Victor Gomoiu","Bucharest","022102","Romania",[352],{"name":353,"role":99,"phone":354},"Raluca Teleanu, Site 0088","0040722241042",{"lat":356,"lon":357},44.43225,26.10626,{"facility":359,"status":8,"city":348,"state":348,"zip":360,"country":350,"contacts":361,"geoPoint":365},"Prof. Dr. Alexandru Obregia Psychiatry Hospital","041914",[362],{"name":363,"role":99,"phone":364},"Cristina Pomeran, Site 0087","0040770419542",{"lat":356,"lon":357},{"facility":367,"status":91,"city":368,"state":369,"zip":370,"country":371,"contacts":372,"geoPoint":375},"Local Institution - 0096","Esplugues de Llobregat","Barcelona [Barcelona]","08950","Spain",[373],{"name":374,"role":99},"Site 0096",{"lat":376,"lon":377},41.37732,2.08809,{"facility":379,"status":8,"city":380,"state":381,"zip":382,"country":371,"contacts":383,"geoPoint":387},"CHUVI- Hospital Alvaro Cunqueiro","Vigo","Pontevedra [Pontevedra]","36203",[384],{"name":385,"role":99,"phone":386},"Elena Rodriguez, Site 0098","+34986217300",{"lat":388,"lon":389},42.23282,-8.72264,{"facility":391,"status":8,"city":392,"zip":393,"country":371,"contacts":394,"geoPoint":398},"Hospital Universitario Virgen Macarena","Seville","41009",[395],{"name":396,"role":99,"phone":397},"SARA EICHAU MADUEÑO, Site 0099","0034955006627",{"lat":399,"lon":400},37.38283,-5.97317,{"facility":402,"status":8,"city":403,"zip":404,"country":371,"contacts":405,"geoPoint":408},"Hospital Universitari i Politecnic La Fe","Valencia","46026",[406],{"name":407,"role":99},"Francisco Pérez-Miralles, Site 0094",{"lat":409,"lon":410},39.47391,-0.37966,{"facility":412,"status":8,"city":413,"zip":414,"country":371,"contacts":415,"geoPoint":418},"Hospital Universitario Miguel Servet","Zaragoza","50009",[416],{"name":417,"role":99},"Jesus Martin Martinez, Site 0101",{"lat":419,"lon":420},41.65606,-0.87734,{"facility":422,"status":8,"city":423,"zip":424,"country":425,"contacts":426,"geoPoint":430},"National Taiwan University Hospital","Taipei","10002","Taiwan",[427],{"name":428,"role":99,"phone":429},"Wang-Tso Lee, Site 0115","0972651495",{"lat":431,"lon":432},25.05306,121.52639,{"facility":434,"status":8,"city":435,"zip":436,"country":437,"contacts":438,"geoPoint":442},"Ondokuz Mayıs Universitesi","Samsun","55270","Turkey (Türkiye)",[439],{"name":440,"role":99,"phone":441},"murat terzi, Site 0109","+905323156884",{"lat":443,"lon":444},41.27976,36.3361,[446,450],{"name":447,"role":99,"phone":448,"email":449},"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","855-907-3286","Clinical.Trials@bms.com",{"name":451,"role":99},"First line of the email MUST contain NCT # and Site #.",[453],{"name":13,"affiliation":13,"role":454},"STUDY_DIRECTOR",[],[457,460],{"label":458,"url":459},"BMS Clinical Trial Information","https:\u002F\u002Fwww.bms.com\u002Fresearchers-and-partners\u002Fclinical-trials-and-research.html",{"label":461,"url":462},"BMS Clinical Trial Patient Recruiting","https:\u002F\u002Fwww.bmsclinicaltrials.com\u002Fus\u002Fen\u002Fclinical-trials\u002FNCT06408259.html",{"nct_id":4,"conditions":464,"biomarkers":465},[21],[],{"nct_id":4,"found":15,"summary":467,"prompt_version":477},{"design":468,"status":469,"heading":470,"summary":471,"follow_up":472,"word_count":473,"commitments":474,"compensation":475,"drugs_mentioned":476},"This is an interventional study comparing ozanimod, fingolimod, and a placebo (an inactive substance) in 194 participants. The specific phase of the study is not mentioned.","completed","Ozanimod vs. Fingolimod for Relapsing-Remitting Multiple Sclerosis in Children and Adolescents","This study is looking at how well and how safely two medications, ozanimod and fingolimod, work for children and teenagers (ages 10 to 17) who have relapsing-remitting multiple sclerosis (RRMS). RRMS is a type of multiple sclerosis where symptoms come and go. You might be able to join if you have been diagnosed with RRMS and have had recent relapses (flare-ups of symptoms). The main goal is to see if one drug leads to fewer relapses over a period of up to two years. The study plans to include 194 participants, but its current recruitment status is unclear.","The primary endpoint, annualized relapse rate, will be measured for up to 2 years.",98,"Not specified in the trial record.","Not stated in the trial record.",[23,38],"v2"]