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).
618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.
This study's planned enrollment of 194 is above the median of 66 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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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, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
Started Apr 2025 (actual). Primary completion is estimated for Apr 2031, 72 months after the start.
Of 28 industry-sponsored phase 3 interventional studies under Multiple Sclerosis, Relapsing-Remitting, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 65. This study's planned 72 months is above that.
Counting every sponsor, half of 38 studies reached it within 48 months; a quarter within 27 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Ozanimod
Multiple Sclerosis, Relapsing-Remitting →