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

Part of paid clinical trials in Loma Linda, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06408259
Phase
PHASE3
Status
Recruiting
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Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Ozanimod — DRUG
    Specified dose on specified days
  • Fingolimod — DRUG
    Specified dose on specified days
  • Placebo — OTHER
    Specified dose on specified days

Study Details

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).

Key Dates

Start date
Apr 8, 2025
Status verified
Apr 2026
Primary completion
Apr 11, 2031
Completion
Jul 13, 2036

Study Design

Enrollment
194 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ozanimod
  • Active Comparator: Fingolimod

Primary Outcome Measure

Annualized relapse rate (ARR) [ Time Frame: Up to 2 years ]

Central Contacts

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

Locations (12)

FacilityCityStateZIPSite coordinators
Local Institution - 0114Loma LindaCalifornia92354
Site 0114
University of California Davis HealthSacramentoCalifornia95817
Frederick Bassal, Site 0130
916-734-3588
University of South FloridaTampaFlorida33612
Natalie Moreo, Site 0053
813-396-9478
Local Institution - 0093ChicagoIllinois60611-
University of Chicago Medical CenterChicagoIllinois60637
Moon Hee Hur, Site 0055
773-702-6673
University of Louisville, Norton Children's Research InstituteLouisvilleKentucky40202
Michael Sweeney, Site 0047
502-629-5606
Local Institution - 0131New BrunswickNew Jersey08901
Site 0131
Local Institution - 0132TeaneckNew Jersey07666-
Local Institution - 0091CincinnatiOhio45229-
Local Institution - 0092PortlandOregon97225
Site 0092
Local Institution - 0133El PasoTexas79912
Site 0133
Medical College of WisconsinMilwaukeeWisconsin53226
Ahmed Obeidat, Site 0033
414-955-0619

Find similar trials in Loma Linda, CA

By research site
Local Institution - 0114· Loma Linda, CAUniversity of California Davis Health· Sacramento, CAUniversity of South Florida· Tampa, FLLocal Institution - 0093· Chicago, ILUniversity of Chicago Medical Center· Chicago, ILUniversity of Louisville, Norton Children's Research Institute· Louisville, KY

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