Actively Recruiting

Phase 3
Age: 10Years - 17Years
All Genders
NCT06408259

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

Led by Bristol-Myers Squibb · Updated on 2026-04-28

194

Participants Needed

33

Research Sites

587 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 10Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of multiple sclerosis with a relapsing remitting course as per 2017 McDonald Criteria
  • At least 1 MS relapse in the previous year or at least 2 relapses in the previous 2 years
  • Evidence of one or more gadolinium-enhancing lesions on MRI within 6 months prior to baseline
  • Expanded Disability Status Scale (EDSS) score from 0 to 5.5 inclusive
Not Eligible

You will not qualify if you...

  • Diagnosis of progressive forms of multiple sclerosis
  • Active or chronic immune system disease other than multiple sclerosis
  • Clinically relevant cardiovascular, liver, neurological, or other major systemic disease
  • Other protocol-defined inclusion or exclusion criteria apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 33 locations

1

Local Institution - 0114

Loma Linda, California, United States, 92354

Not Yet Recruiting

2

University of California Davis Health

Sacramento, California, United States, 95817

Actively Recruiting

3

University of South Florida

Tampa, Florida, United States, 33612

Actively Recruiting

4

Local Institution - 0093

Chicago, Illinois, United States, 60611

Withdrawn

5

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Actively Recruiting

6

University of Louisville, Norton Children's Research Institute

Louisville, Kentucky, United States, 40202

Actively Recruiting

7

Local Institution - 0131

New Brunswick, New Jersey, United States, 08901

Not Yet Recruiting

8

Local Institution - 0132

Teaneck, New Jersey, United States, 07666

Withdrawn

9

Local Institution - 0091

Cincinnati, Ohio, United States, 45229

Withdrawn

10

Local Institution - 0092

Portland, Oregon, United States, 97225

Not Yet Recruiting

11

Local Institution - 0133

El Paso, Texas, United States, 79912

Not Yet Recruiting

12

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

13

Royal Children's Hospital

Melbourne, Victoria, Australia, 3052

Actively Recruiting

14

University of Naples Federico II

Naples, Campania, Italy, 80131

Actively Recruiting

15

Ospedale San Raffaele

Milan, Lombardy, Italy, 20132

Actively Recruiting

16

Local Institution - 0081

Milan, Lombardy, Italy, 20133

Not Yet Recruiting

17

Neurological Center Of Latium

Rome, Roma, Italy, 00178

Actively Recruiting

18

Local Institution - 0078

Mexico City, DIF, Mexico, 04530

Withdrawn

19

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Greater Poland Voivodeship, Poland, 60-355

Actively Recruiting

20

2Ca Braga

Braga, Portugal, 4710-243

Actively Recruiting

21

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

Coimbra, Portugal, 3000-602

Actively Recruiting

22

Centro Hospitalar de Lisboa Central

Lisbon, Portugal, 1169-050

Actively Recruiting

23

Local Institution - 0102

Porto, Portugal, 4200-319

Withdrawn

24

Local Institution - 0134

Caguas, Puerto Rico, 00725

Not Yet Recruiting

25

Spitalul Clinic de Copii Doctor Victor Gomoiu

Bucharest, Bucharest, Romania, 022102

Actively Recruiting

26

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, Bucharest, Romania, 041914

Actively Recruiting

27

Local Institution - 0096

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

Not Yet Recruiting

28

CHUVI- Hospital Alvaro Cunqueiro

Vigo, Pontevedra [Pontevedra], Spain, 36203

Actively Recruiting

29

Hospital Universitario Virgen Macarena

Seville, Spain, 41009

Actively Recruiting

30

Hospital Universitari i Politecnic La Fe

Valencia, Spain, 46026

Actively Recruiting

31

Hospital Universitario Miguel Servet

Zaragoza, Spain, 50009

Actively Recruiting

32

National Taiwan University Hospital

Taipei, Taiwan, 10002

Actively Recruiting

33

Ondokuz Mayıs Universitesi

Samsun, Turkey (Türkiye), 55270

Actively Recruiting

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Research Team

B

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

F

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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