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NCT06408259PHASE3Recruiting

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

Bristol-Myers Squibb

Start Date

4/8/2025

Completion Date

7/13/2036

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).

Eligibility Criteria

Age Range: 10 years to 17 years

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.

Interventions

DRUG

Ozanimod

DRUG

Fingolimod

OTHER

Placebo

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Conditions

Multiple Sclerosis, Relapsing-Remitting

Locations

Local Institution - 0114

Loma Linda, California 92354

United States

University of California Davis Health

Sacramento, California 95817

United States

University of South Florida

Tampa, Florida 33612

United States

Local Institution - 0093

Chicago, Illinois 60611

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

University of Louisville, Norton Children's Research Institute

Louisville, Kentucky 40202

United States

Local Institution - 0131

New Brunswick, New Jersey 08901

United States

Local Institution - 0132

Teaneck, New Jersey 07666

United States

Local Institution - 0091

Cincinnati, Ohio 45229

United States

Local Institution - 0092

Portland, Oregon 97225

United States

Local Institution - 0133

El Paso, Texas 79912

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Royal Children's Hospital

Melbourne, Victoria 3052

Australia

University of Naples Federico II

Naples, Campania 80131

Italy

Ospedale San Raffaele

Milan, Lombardy 20132

Italy

Local Institution - 0081

Milan, Lombardy 20133

Italy

Neurological Center Of Latium

Rome, Roma 00178

Italy

Local Institution - 0078

Mexico City, DIF 04530

Mexico

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Greater Poland Voivodeship 60-355

Poland

2Ca Braga

Braga, 4710-243

Portugal

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

Coimbra, 3000-602

Portugal

Centro Hospitalar de Lisboa Central

Lisbon, 1169-050

Portugal

Local Institution - 0102

Porto, 4200-319

Portugal

Local Institution - 0134

Caguas, 00725

Puerto Rico

Spitalul Clinic de Copii Doctor Victor Gomoiu

Bucharest, Bucharest 022102

Romania

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, Bucharest 041914

Romania

Local Institution - 0096

Esplugues de Llobregat, Barcelona [Barcelona] 08950

Spain

CHUVI- Hospital Alvaro Cunqueiro

Vigo, Pontevedra [Pontevedra] 36203

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain

Hospital Universitari i Politecnic La Fe

Valencia, 46026

Spain

Hospital Universitario Miguel Servet

Zaragoza, 50009

Spain

National Taiwan University Hospital

Taipei, 10002

Taiwan

Ondokuz Mayıs Universitesi

Samsun, 55270

Turkey (Türkiye)