RecruitingPhase 3NCT06408259

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

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

Sponsor

Bristol-Myers Squibb

Enrollment

194 participants

Start Date

Apr 8, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis, Relapsing-Remitting

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

Min Age: 10 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study compares ozanimod (a pill taken daily) to injectable therapies for relapsing-remitting multiple sclerosis (MS). It is looking at whether ozanimod is more effective and equally safe compared to existing injectable treatments for patients whose MS is still active. **You may be eligible if...** - You have been diagnosed with relapsing-remitting MS (confirmed by McDonald criteria) - Your MS has been active recently — at least one relapse in the past year, two relapses in the past two years, or a brain lesion found on MRI - Your disability level meets the study's requirements **You may NOT be eligible if...** - You have a progressive form of MS - You have certain heart conditions or eye conditions that ozanimod could worsen - You have certain active infections or immune system problems - You have taken specific immunosuppressive drugs recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOzanimod

Specified dose on specified days

DRUGFingolimod

Specified dose on specified days

OTHERPlacebo

Specified dose on specified days

Locations(33)

Local Institution - 0114

Loma Linda, California, United States

University of California Davis Health

Sacramento, California, United States

University of South Florida

Tampa, Florida, United States

Local Institution - 0093

Chicago, Illinois, United States

University of Chicago Medical Center

Chicago, Illinois, United States

University of Louisville, Norton Children's Research Institute

Louisville, Kentucky, United States

Local Institution - 0131

New Brunswick, New Jersey, United States

Local Institution - 0132

Teaneck, New Jersey, United States

Local Institution - 0091

Cincinnati, Ohio, United States

Local Institution - 0092

Portland, Oregon, United States

Local Institution - 0133

El Paso, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Royal Children's Hospital

Melbourne, Victoria, Australia

University of Naples Federico II

Naples, Campania, Italy

Ospedale San Raffaele

Milan, Lombardy, Italy

Local Institution - 0081

Milan, Lombardy, Italy

Neurological Center Of Latium

Rome, Roma, Italy

Local Institution - 0078

Mexico City, DIF, Mexico

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Greater Poland Voivodeship, Poland

2Ca Braga

Braga, Portugal

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

Coimbra, Portugal

Centro Hospitalar de Lisboa Central

Lisbon, Portugal

Local Institution - 0102

Porto, Portugal

Local Institution - 0134

Caguas, Puerto Rico

Spitalul Clinic de Copii Doctor Victor Gomoiu

Bucharest, Bucharest, Romania

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, Bucharest, Romania

Local Institution - 0096

Esplugues de Llobregat, Barcelona [Barcelona], Spain

CHUVI- Hospital Alvaro Cunqueiro

Vigo, Pontevedra [Pontevedra], Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

National Taiwan University Hospital

Taipei, Taiwan

Ondokuz Mayıs Universitesi

Samsun, Turkey (Türkiye)

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NCT06408259

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