Trial Radar AI | ||
|---|---|---|
De klinische studie NCT06408259 voor Multiple Sclerose, Relapsing-Remitting is recruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Eén studie komt overeen met de filtercriteria
Kaartweergave
Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
Informatie over klinische studies is voornamelijk in het Engels beschikbaar. Trial Radar AI kan echter helpen! Klik op 'Leg studie uit' om de informatie over de studie te bekijken en te bespreken in de taal van uw keuze.
De klinische studie NCT06408259 onderzoekt behandeling bij Multiple Sclerose, Relapsing-Remitting. Deze Fase 3 interventioneel-studie heeft de status recruterend. Het doel is om 194 deelnemers te includeren vanaf 8 april 2025. De studie wordt geleid door Celgene en de voltooiing is gepland op 13 juli 2036. Laatste update op ClinicalTrials.gov: 2 december 2025.
Beknopte samenvatting
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).
Officiële titel
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
Aandoeningen
Multiple Sclerose, Relapsing-RemittingAndere studie-ID's
- IM047-050
- 2022-501332-42 (Register-ID) (EU Trial Number)
- U1111-1281-5433 (Register-ID) (UTN)
NCT-ID
Startdatum (Werkelijk)
2025-04-08
Laatste update geplaatst
2025-12-02
Verwachte einddatum
2036-07-13
Inschrijving (Geschat)
194
Studietype
Interventioneel
FASE
Fase 3
Status
Recruterend
Trefwoorden
Multiple Sclerosis
Relapsing-Remitting
Ozanimod
Zeposia®
Relapsing-Remitting
Ozanimod
Zeposia®
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Viervoudig blind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelOzanimod | Ozanimod Specified dose on specified days PLACEBO Specified dose on specified days |
Actieve comparatorFingolimod | Fingolimod Specified dose on specified days PLACEBO Specified dose on specified days |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Annualized relapse rate (ARR) | Up to 2 years |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Proportion of participants who did not have a confirmed relapse | At 12 and 24 months | |
Number of gadolinium enhancing (GdE) T1 lesions | At month 6 and month 12 | |
Number of new or newly enlarging hyperintense lesions on T2 magnetic resonance imaging (MRI) sequences | At 6, 12, 18, and 24 months | |
Incidence of treatment-emergent adverse events (TEAEs) over the treatment period and over the post-treatment follow-up period | Up to 87 months | |
Incidence of adverse event of special interests (AESIs) over the treatment period and over the post-treatment follow-up period | Up to 87 months | |
Adverse events (AEs) leading to discontinuation over the treatment period and over the post-treatment follow-up period | Up to 87 months | |
Steady state plasma concentrations of ozanimod | At day 90 | |
Steady state plasma concentrations of the primary active metabolite CC112273 | At day 90 | |
Change from baseline pharmacodynamics (PD) biomarkers of absolute lymphocyte count | At day 90 and throughout the study up to 24 months |
Geschiktheidscriteria
Leeftijd van deelnemers
Kind
Minimumleeftijd
10 Years
Geslachten die in aanmerking komen voor de studie
Allen
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:
i) At least 1 MS relapse/attack in the previous year prior to screening.
ii) At least 2 MS relapses/attacks in the previous 2 years prior to screening.
iii) Evidence of 1 or more gadolinium-enhancing (GdE) lesions on magnetic resonance imaging (MRI) within 6 months prior to baseline (including screening MRI).
- Has an Expanded Disability Status Scale (EDSS) score of 0 to 5.5, both inclusive.
- 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.
- Other protocol-defined Inclusion/Exclusion criteria apply.
CelgeneCentraal Contactpersoon
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com, 855-907-3286, [email protected]
Contact: First line of the email MUST contain NCT # and Site #.
32 Studielocaties in 10 landen
California
Local Institution - 0114, Loma Linda, California, 92354, United States
Site 0114, Contact
Nog niet rekruterend
Local Institution - 0130, Sacramento, California, 95817, United States
Site 0130, Contact
Nog niet rekruterend
Florida
University of South Florida, Tampa, Florida, 33612, United States
Natalie Moreo, Site 0053, Contact, 813-396-9478
Recruterend
Illinois
Local Institution - 0093, Chicago, Illinois, 60611, United States
Ingetrokken
Local Institution - 0055, Chicago, Illinois, 60637, United States
Site 0055, Contact
Nog niet rekruterend
Kentucky
Local Institution - 0047, Louisville, Kentucky, 40202, United States
Site 0047, Contact
Nog niet rekruterend
New Jersey
Local Institution - 0131, New Brunswick, New Jersey, 08901, United States
Site 0131, Contact
Nog niet rekruterend
Local Institution - 0132, Teaneck, New Jersey, 07666, United States
Ingetrokken
Ohio
Local Institution - 0091, Cincinnati, Ohio, 45229, United States
Ingetrokken
Oregon
Local Institution - 0092, Portland, Oregon, 97225, United States
Site 0092, Contact
Nog niet rekruterend
Texas
Local Institution - 0133, El Paso, Texas, 79912, United States
Site 0133, Contact
Nog niet rekruterend
Wisconsin
Local Institution - 0033, Milwaukee, Wisconsin, 53226, United States
Site 0033, Contact
Nog niet rekruterend
Victoria
Royal Children's Hospital, Melbourne, Victoria, 3052, Australia
Eppie Yiu, Site 0113, Contact, 6139455661
Recruterend
Campania
University of Naples Federico II, Napoli, Campania, 80131, Italy
Vincenzo Brescia Morra, Site 0083, Contact, +39081743741
Recruterend
Lombardy
Ospedale San Raffaele, Milan, Lombardy, 20132, Italy
Massimo Filippi, Site 0082, Contact, +390226433958
Recruterend
Local Institution - 0081, Milan, Lombardy, 20133, Italy
Site 0081, Contact
Nog niet rekruterend
Roma
Neurological Center Of Latium, Rome, Roma, 00178, Italy
Carlo Pozzilli, Site 0086, Contact, 06.3377.5441
Recruterend
DIF
Local Institution - 0078, Mexico City, DIF, 04530, Mexico
Ingetrokken
Greater Poland Voivodeship
Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan, Greater Poland Voivodeship, 60-355, Poland
Barbara Steinborn, Site 0108, Contact, 48618691255
Recruterend
2Ca Braga, Braga, 4710-243, Portugal
Joao Cerqueira, Site 0103, Contact, +351915301556
Recruterend
Unidade Local de Saúde de Coimbra, E.P.E., Coimbra, 3000-602, Portugal
Filipe Palavra, Site 0105, Contact, +351914632128
Recruterend
Centro Hospitalar de Lisboa Central, Lisbon, 1169-050, Portugal
João Sequeira, Site 0104, Contact, 00351912576085
Recruterend
Local Institution - 0102, Porto, 4200-319, Portugal
Ingetrokken
București
Spitalul Clinic de Copii Doctor Victor Gomoiu, Bucharest, București, 022102, Romania
Raluca Teleanu, Site 0088, Contact, 0040722241042
Recruterend
Prof. Dr. Alexandru Obregia Psychiatry Hospital, Bucharest, București, 041914, Romania
Cristina Pomeran, Site 0087, Contact, 0040770419542
Recruterend
Barcelona [Barcelona]
Local Institution - 0096, Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain
Site 0096, Contact
Nog niet rekruterend
Pontevedra [Pontevedra]
CHUVI- Hospital Alvaro Cunqueiro, Vigo, Pontevedra [Pontevedra], 36203, Spain
Elena Rodriguez, Site 0098, Contact, +34986217300
Recruterend
Hospital Universitario Virgen Macarena, Seville, 41009, Spain
SARA EICHAU MADUEÑO, Site 0099, Contact, 0034955006627
Recruterend
Hospital Universitari i Politecnic La Fe, Valencia, 46026, Spain
Francisco Pérez-Miralles, Site 0094, Contact
Recruterend
Hospital Universitario Miguel Servet, Zaragoza, 50009, Spain
Jesus Martin Martinez, Site 0101, Contact
Recruterend
National Taiwan University Hospital, Taipei, 10002, Taiwan
Wang-Tso Lee, Site 0115, Contact, 0972651495
Recruterend
Local Institution - 0109, Samsun, 55270, Turkey (Türkiye)
Site 0109, Contact
Nog niet rekruterend