Ozanimod vs. Fingolimod for Relapsing-Remitting Multiple Sclerosis in Children and Adolescents

This study is looking at how well and how safely two medications, ozanimod and fingolimod, work for children and teenagers (ages 10 to 17) who have relapsing-remitting multiple sclerosis (RRMS). RRMS is a type of multiple sclerosis where symptoms come and go. You might be able to join if you have been diagnosed with RRMS and have had recent relapses (flare-ups of symptoms). The main goal is to see if one drug leads to fewer relapses over a period of up to two years. The study plans to include 194 participants, but its current recruitment status is unclear.

Study design
This is an interventional study comparing ozanimod, fingolimod, and a placebo (an inactive substance) in 194 participants. The specific phase of the study is not mentioned.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, annualized relapse rate, will be measured for up to 2 years.

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NCT06408259

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

Recruiting
PHASE3Ages 10–17InterventionalTreatment
Bristol-Myers Squibb
~194 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:OzanimodFingolimodPlacebo

At a glance

Recruiting sites
21 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Annualized relapse rate (ARR)
Measured over Up to 2 years
Multiple Sclerosis, Relapsing-Remitting
33 sites across 23 states
Portugal4
Spain3
California2
Illinois2
New Jersey2
Lombardy2
Bucharest2
Florida1
  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:

Exclusion

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.
  • Annualized relapse rate (ARR)Up to 2 years