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

April 23, 2026 updated by: Bristol-Myers Squibb

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

194

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3052
        • Recruiting
        • Royal Children's Hospital
        • Contact:
          • Eppie Yiu, Site 0113
          • Phone Number: 6139455661
  • Italy
    • Campania
      • Naples, Campania, Italy, 80131
        • Recruiting
        • University of Naples Federico II
        • Contact:
          • Vincenzo Brescia Morra, Site 0083
          • Phone Number: +39081743741
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele
        • Contact:
          • Massimo Filippi, Site 0082
          • Phone Number: +390226433958
      • Milan, Lombardy, Italy, 20133
        • Not yet recruiting
        • Local Institution - 0081
        • Contact:
          • Site 0081
    • Roma
      • Rome, Roma, Italy, 00178
        • Recruiting
        • Neurological Center Of Latium
        • Contact:
          • Carlo Pozzilli, Site 0086
          • Phone Number: 06.3377.5441
  • Mexico
    • DIF
      • Mexico City, DIF, Mexico, 04530
        • Withdrawn
        • Local Institution - 0078
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-355
        • Recruiting
        • Uniwersytecki Szpital Kliniczny w Poznaniu
        • Contact:
          • Barbara Steinborn, Site 0108
          • Phone Number: 48618691255
  • Portugal
      • Braga, Portugal, 4710-243
        • Recruiting
        • 2Ca Braga
        • Contact:
          • Joao Cerqueira, Site 0103
          • Phone Number: +351915301556
      • Coimbra, Portugal, 3000-602
        • Recruiting
        • Unidade Local de Saúde de Coimbra, E.P.E.
        • Contact:
          • Filipe Palavra, Site 0105
          • Phone Number: +351914632128
      • Lisbon, Portugal, 1169-050
        • Recruiting
        • Centro Hospitalar de Lisboa Central
        • Contact:
          • João Sequeira, Site 0104
          • Phone Number: 00351912576085
      • Porto, Portugal, 4200-319
        • Withdrawn
        • Local Institution - 0102
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Not yet recruiting
        • Local Institution - 0134
        • Contact:
          • Site 0134
  • Romania
    • Bucharest
      • Bucharest, Bucharest, Romania, 041914
        • Recruiting
        • Prof. Dr. Alexandru Obregia Psychiatry Hospital
        • Contact:
          • Cristina Pomeran, Site 0087
          • Phone Number: 0040770419542
      • Bucharest, Bucharest, Romania, 022102
        • Recruiting
        • Spitalul Clinic de Copii Doctor Victor Gomoiu
        • Contact:
          • Raluca Teleanu, Site 0088
          • Phone Number: 0040722241042
  • Spain
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
          • SARA EICHAU MADUEÑO, Site 0099
          • Phone Number: 0034955006627
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
        • Contact:
          • Francisco Pérez-Miralles, Site 0094
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Universitario Miguel Servet
        • Contact:
          • Jesus Martin Martinez, Site 0101
    • Barcelona [Barcelona]
      • Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
        • Not yet recruiting
        • Local Institution - 0096
        • Contact:
          • Site 0096
    • Pontevedra [Pontevedra]
      • Vigo, Pontevedra [Pontevedra], Spain, 36203
        • Recruiting
        • CHUVI- Hospital Alvaro Cunqueiro
        • Contact:
          • Elena Rodriguez, Site 0098
          • Phone Number: +34986217300
  • Taiwan
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Wang-Tso Lee, Site 0115
          • Phone Number: 0972651495
  • Turkey (Türkiye)
      • Samsun, Turkey (Türkiye), 55270
        • Recruiting
        • Ondokuz Mayıs Universitesi
        • Contact:
          • murat terzi, Site 0109
          • Phone Number: +905323156884
  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Not yet recruiting
        • Local Institution - 0114
        • Contact:
          • Site 0114
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Health
        • Contact:
          • Frederick Bassal, Site 0130
          • Phone Number: 916-734-3588
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • University of South Florida
        • Contact:
          • Natalie Moreo, Site 0053
          • Phone Number: 813-396-9478
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center
        • Contact:
          • Moon Hee Hur, Site 0055
          • Phone Number: 773-702-6673
      • Chicago, Illinois, United States, 60611
        • Withdrawn
        • Local Institution - 0093
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville, Norton Children's Research Institute
        • Contact:
          • Michael Sweeney, Site 0047
          • Phone Number: 502-629-5606
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Not yet recruiting
        • Local Institution - 0131
        • Contact:
          • Site 0131
      • Teaneck, New Jersey, United States, 07666
        • Withdrawn
        • Local Institution - 0132
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Withdrawn
        • Local Institution - 0091
    • Oregon
      • Portland, Oregon, United States, 97225
        • Not yet recruiting
        • Local Institution - 0092
        • Contact:
          • Site 0092
    • Texas
      • El Paso, Texas, United States, 79912
        • Not yet recruiting
        • Local Institution - 0133
        • Contact:
          • Site 0133
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Ahmed Obeidat, Site 0033
          • Phone Number: 414-955-0619

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ozanimod
Other: Placebo
Specified dose on specified days
Drug: Ozanimod
Specified dose on specified days
Active Comparator: Fingolimod
Other: Placebo
Specified dose on specified days
Drug: Fingolimod
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Annualized relapse rate (ARR)
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants who did not have a confirmed relapse
Time Frame: At 12 and 24 months
At 12 and 24 months
Number of gadolinium enhancing (GdE) T1 lesions
Time Frame: At month 6 and month 12
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
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
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
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
Up to 87 months
Steady state plasma concentrations of ozanimod
Time Frame: At day 90
At day 90
Steady state plasma concentrations of the primary active metabolite CC112273
Time Frame: At day 90
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
At day 90 and throughout the study up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2025

Primary Completion (Estimated)

April 11, 2031

Study Completion (Estimated)

July 13, 2036

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM047-050
  • 2022-501332-42 (Other Identifier: EU CTR)
  • U1111-1281-5433 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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