Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

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).

Key facts

Study ID

NCT06408259

Run by

Bristol-Myers Squibb

People needed

194

Starts

2025-04-08

Expected to finish

2036-07-13

Last updated by the study team

2026-04-28

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ondokuz Mayıs Universitesi — Samsun, Turkey (Türkiye) (enrolling)
• University of California Davis Health — Sacramento, California, United States (enrolling)
• University of South Florida — Tampa, Florida, United States (enrolling)
• Neurological Center Of Latium — Rome, Roma, Italy (enrolling)
• Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan, Greater Poland Voivodeship, Poland (enrolling)
• 2Ca Braga — Braga, Portugal (enrolling)
• Unidade Local de Saúde de Coimbra, E.P.E. — Coimbra, Portugal (enrolling)
• Centro Hospitalar de Lisboa Central — Lisbon, Portugal (enrolling)
• Spitalul Clinic de Copii Doctor Victor Gomoiu — Bucharest, Bucharest, Romania (enrolling)
• Prof. Dr. Alexandru Obregia Psychiatry Hospital — Bucharest, Bucharest, Romania (enrolling)
• CHUVI- Hospital Alvaro Cunqueiro — Vigo, Pontevedra [Pontevedra], Spain (enrolling)
• Hospital Universitario Virgen Macarena — Seville, Spain (enrolling)
• Hospital Universitari i Politecnic La Fe — Valencia, Spain (enrolling)
• Hospital Universitario Miguel Servet — Zaragoza, Spain (enrolling)
• National Taiwan University Hospital — Taipei, Taiwan (enrolling)
• University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• University of Louisville, Norton Children's Research Institute — Louisville, Kentucky, United States (enrolling)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
• Royal Children's Hospital — Melbourne, Victoria, Australia (enrolling)
• University of Naples Federico II — Naples, Campania, Italy (enrolling)
• Ospedale San Raffaele — Milan, Lombardy, Italy (enrolling)
• Local Institution - 0093 — Chicago, Illinois, United States
• Local Institution - 0081 — Milan, Lombardy, Italy
• Local Institution - 0114 — Loma Linda, California, United States
• Local Institution - 0131 — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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