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Clinical Trials in Australia / NCT06408259
Recruiting Phase 3

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

NCT06408259 · tracked via the Priya Life Science Australia tracker
Phase
Phase 3
Started
2025-04-08
Last updated
2026-09-10

Condition(s) studied

Multiple Sclerosis, Relapsing-Remitting

Investigational drug(s) / intervention(s)

Ozanimod →Fingolimod →Placebo

Ozanimod: Specified dose on specified days

Fingolimod: Specified dose on specified days

Placebo: Specified dose on specified days

Study 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

Sex
ALL
Min age
10 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (33)

FacilityCityRegionStatus
Local Institution - 0114 Loma Linda California Not Yet Recruiting
University of California Davis Health Sacramento California Recruiting
University of South Florida Tampa Florida Recruiting
Local Institution - 0093 Chicago Illinois Withdrawn
University of Chicago Medical Center Chicago Illinois Recruiting
University of Louisville, Norton Children's Research Institute Louisville Kentucky Recruiting
Local Institution - 0131 New Brunswick New Jersey Not Yet Recruiting
Local Institution - 0132 Teaneck New Jersey Withdrawn
Local Institution - 0091 Cincinnati Ohio Withdrawn
Local Institution - 0092 Portland Oregon Not Yet Recruiting
Local Institution - 0133 El Paso Texas Not Yet Recruiting
Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Royal Children's Hospital Melbourne Victoria Recruiting
University of Naples Federico II Naples Campania Recruiting
Ospedale San Raffaele Milan Lombardy Recruiting
Local Institution - 0081 Milan Lombardy Not Yet Recruiting
Neurological Center Of Latium Rome Roma Recruiting
Local Institution - 0078 Mexico City DIF Withdrawn
Local Institution - 0108 Poznan Greater Poland Voivodeship Completed
2Ca Braga Braga Portugal Recruiting
Unidade Local de Saúde de Coimbra, E.P.E. Coimbra Portugal Recruiting
Centro Hospitalar de Lisboa Central Lisbon Portugal Recruiting
Local Institution - 0102 Porto Portugal Withdrawn
Local Institution - 0134 Caguas Puerto Rico Not Yet Recruiting
Spitalul Clinic de Copii Doctor Victor Gomoiu Bucharest Bucharest Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital Bucharest Bucharest Recruiting
Local Institution - 0096 Esplugues de Llobregat Barcelona [Barcelona] Not Yet Recruiting
CHUVI- Hospital Alvaro Cunqueiro Vigo Pontevedra [Pontevedra] Recruiting
Hospital Universitario Virgen Macarena Seville Spain Recruiting
Hospital Universitari i Politecnic La Fe Valencia Spain Recruiting
Hospital Universitario Miguel Servet Zaragoza Spain Recruiting
National Taiwan University Hospital Taipei Taiwan Recruiting
Ondokuz Mayıs Universitesi Samsun Turkey (Türkiye) Recruiting

More Bristol-Myers Squibb trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06408259 on ClinicalTrials.gov ↗ ← All trials in Australia