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RECRUITING
NCT06408259
PHASE3

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

Sponsor: Celgene

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

10 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

194

Start Date

2025-04-08

Completion Date

2036-07-13

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

DRUG

Ozanimod

Specified dose on specified days

DRUG

Fingolimod

Specified dose on specified days

OTHER

Placebo

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

Local Institution - 0047

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, București, Romania

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, București, 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)