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

NCT06408259 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: IM047-0502022-501332-42U1111-1281-5433
• Study Type: interventional
• Target: 194
• Locations: 11 countries
• Sites: 33

Brief Summary

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).

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis; Relapsing-Remitting; Ozanimod; Zeposia®

Outcome Measures

Primary Outcomes (1)

• Annualized relapse rate (ARR)

  Up to 2 years

Secondary Outcomes (9)

• Proportion of participants who did not have a confirmed relapse

  At 12 and 24 months

• Number of gadolinium enhancing (GdE) T1 lesions

  At month 6 and month 12

• Number of new or newly enlarging hyperintense lesions on T2 magnetic resonance imaging (MRI) sequences

  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

  Up to 87 months

• Incidence of adverse event of special interests (AESIs) over the treatment period and over the post-treatment follow-up period

  Up to 87 months

Study Arms (2)

Ozanimod

EXPERIMENTAL

Drug: Ozanimod; Other: Placebo

Fingolimod

ACTIVE COMPARATOR

Drug: Fingolimod; Other: Placebo

Interventions

Ozanimod DRUG

Specified dose on specified days

Ozanimod

Fingolimod DRUG

Specified dose on specified days

Fingolimod

Placebo OTHER

Specified dose on specified days

Fingolimod; Ozanimod

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (33)

Local Institution - 0114

Loma Linda, California, 92354, United States

NOT YET RECRUITING

University of California Davis Health

Sacramento, California, 95817, United States

RECRUITING

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

Local Institution - 0093

Chicago, Illinois, 60611, United States

WITHDRAWN

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

University of Louisville, Norton Children's Research Institute

Louisville, Kentucky, 40202, United States

RECRUITING

Local Institution - 0131

New Brunswick, New Jersey, 08901, United States

NOT YET RECRUITING

Local Institution - 0132

Teaneck, New Jersey, 07666, United States

WITHDRAWN

Local Institution - 0091

Cincinnati, Ohio, 45229, United States

WITHDRAWN

Local Institution - 0092

Portland, Oregon, 97225, United States

NOT YET RECRUITING

Local Institution - 0133

El Paso, Texas, 79912, United States

NOT YET RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Royal Children's Hospital

Melbourne, Victoria, 3052, Australia

RECRUITING

University of Naples Federico II

Naples, Campania, 80131, Italy

RECRUITING

Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

RECRUITING

Local Institution - 0081

Milan, Lombardy, 20133, Italy

NOT YET RECRUITING

Neurological Center Of Latium

Rome, Roma, 00178, Italy

RECRUITING

Local Institution - 0078

Mexico City, DIF, 04530, Mexico

WITHDRAWN

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Greater Poland Voivodeship, 60-355, Poland

RECRUITING

2Ca Braga

Braga, 4710-243, Portugal

RECRUITING

Unidade Local de Saúde de Coimbra, E.P.E.

Coimbra, 3000-602, Portugal

RECRUITING

Centro Hospitalar de Lisboa Central

Lisbon, 1169-050, Portugal

RECRUITING

Local Institution - 0102

Porto, 4200-319, Portugal

WITHDRAWN

Local Institution - 0134

Caguas, 00725, Puerto Rico

NOT YET RECRUITING

Spitalul Clinic de Copii Doctor Victor Gomoiu

Bucharest, Bucharest, 022102, Romania

RECRUITING

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, Bucharest, 041914, Romania

RECRUITING

Local Institution - 0096

Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain

NOT YET RECRUITING

CHUVI- Hospital Alvaro Cunqueiro

Vigo, Pontevedra [Pontevedra], 36203, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Ondokuz Mayıs Universitesi

Samsun, 55270, Turkey (Türkiye)

RECRUITING

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

ozanimod; Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 10, 2024
• Study Start: April 8, 2025
• Primary Completion (Estimated): April 11, 2031
• Study Completion (Estimated): July 13, 2036
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

TU (1); AU (1); US (12); PT (4); PR (1); RO (2); IT (4); ES (5); PL (1); TW (1); ME (1)