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Evaluating Ozanimod versus Fingolimod for Children with Relapsing Remitting Multiple Sclerosis

A Phase 3, Multicenter, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ozanimod Compared to Oral Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

Phase 3 Interventional Bristol-Myers Squibb · NCT06408259

This study is testing whether ozanimod works better than fingolimod for children and teens with relapsing remitting multiple sclerosis.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment194 (estimated)
Ages10 Years to 17 Years
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Locations33 sites (Loma Linda, California and 32 other locations)
Trial IDNCT06408259 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness and safety of ozanimod compared to fingolimod in treating children and adolescents diagnosed with relapsing remitting multiple sclerosis (RRMS). Participants will receive either ozanimod, fingolimod, or a placebo, and the study will monitor drug levels, effects, and tolerability. The research focuses on individuals who have experienced recent disease activity, ensuring a targeted approach to treatment evaluation.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents diagnosed with relapsing remitting multiple sclerosis who have experienced recent disease activity.

Not a fit: Patients with progressive forms of multiple sclerosis or other significant immune system diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for children and adolescents with relapsing remitting multiple sclerosis.

How similar studies have performed: Previous studies have shown promise in evaluating treatments for multiple sclerosis, but this specific comparison of ozanimod and fingolimod in a pediatric population is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Loma Linda, California and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple Sclerosis, Relapsing-RemittingMultiple SclerosisRelapsing-RemittingOzanimodZeposia®
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.