Recruiting
Phase 3

Ozanimod vs. Fingolimod

Sponsor:

Bristol-Myers Squibb

Code:

NCT06408259

Conditions

Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Interventions

Ozanimod

Fingolimod

Placebo

Study Details

Brief summary:

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).

Conditions

Multiple Sclerosis, Relapsing-Remitting

Study ID

NCT06408259

Start date

Apr 8, 2025

Status verified date

Apr, 2026

Completion date

Jul 13, 2036

Anticipated

Primary completion date

Apr 11, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

194 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ozanimod

active comparator: Fingolimod

Interventions

Ozanimod

Specified dose on specified days

Fingolimod

Specified dose on specified days

Placebo

Specified dose on specified days

Primary outcome measure

  • Annualized relapse rate (ARR) [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

University of California Davis Health

Recruiting

Sacramento, California, United States, 95817

Contacts

Frederick Bassal, Site 0130

916-734-3588

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

Natalie Moreo, Site 0053

813-396-9478

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Moon Hee Hur, Site 0055

773-702-6673

University of Louisville, Norton Children's Research Institute

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Michael Sweeney, Site 0047

502-629-5606

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Ahmed Obeidat, Site 0033

414-955-0619

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

  • Multiple Sclerosis
  • Relapsing-Remitting
  • Ozanimod
  • Zeposia®

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-04-28.