A Phase 3 interventional study of Ozanimod and Fingolimod in Multiple Sclerosis, Relapsing-Remitting, sponsored by Bristol-Myers Squibb. Recruiting at 33 sites in 11 countries. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
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).
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:
Drug: Ozanimod · Other: Placebo
Drug: Fingolimod · Other: Placebo
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Annualized relapse rate (ARR)
Time frame: Up to 2 years
Proportion of participants who did not have a confirmed relapse
Time frame: At 12 and 24 months
Number of gadolinium enhancing (GdE) T1 lesions
Time frame: At month 6 and month 12
Number of new or newly enlarging hyperintense lesions on T2 magnetic resonance imaging (MRI) sequences
Time frame: 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
Time frame: Up to 87 months
Incidence of adverse event of special interests (AESIs) over the treatment period and over the post-treatment follow-up period
Time frame: Up to 87 months
Adverse events (AEs) leading to discontinuation over the treatment period and over the post-treatment follow-up period
Time frame: Up to 87 months
Steady state plasma concentrations of ozanimod
Time frame: At day 90
Steady state plasma concentrations of the primary active metabolite CC112273
Time frame: At day 90
Change from baseline pharmacodynamics (PD) biomarkers of absolute lymphocyte count
Time frame: At day 90 and throughout the study up to 24 months
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Sap, Csr
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Multiple Sclerosis, Relapsing-Remitting→
Bristol-Myers Squibb