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Bored Studies
RecruitingPhase 3

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

Bristol-Myers Squibb · NCT06408259

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 10–17 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
194
US sites recruiting
5
Study start
April 8, 2025
Record last updated
September 10, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Ozanimod; Fingolimod; Placebo

Conditions: Multiple Sclerosis, Relapsing-Remitting

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • University of California Davis Health

    Sacramento, CA 95817

    Site contact: Frederick Bassal, Site 0130 · 916-734-3588

  • University of South Florida

    Tampa, FL 33612

    Site contact: Natalie Moreo, Site 0053 · 813-396-9478

  • University of Chicago Medical Center

    Chicago, IL 60637

    Site contact: Moon Hee Hur, Site 0055 · 773-702-6673

  • University of Louisville, Norton Children's Research Institute

    Louisville, KY 40202

    Site contact: Michael Sweeney, Site 0047 · 502-629-5606

  • Medical College of Wisconsin

    Milwaukee, WI 53226

    Site contact: Ahmed Obeidat, Site 0033 · 414-955-0619

Study contacts (from the official record)

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
  • First line of the email MUST contain NCT # and Site #.
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