Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06408259 | RECRUITING | Multiple Sclerosis, Relapsing-Remitting

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

Celgene

Brief 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).

Condition or disease

Multiple Sclerosis, Relapsing-Remitting

Intervention/treatment

Ozanimod

Fingolimod

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 194 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-04-08
Estimated Primary Completion Date : 2031-04-11
Estimated Study Completion Date : 2036-07-13

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 10 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

Location Details

NCT06408259

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Arizona

Local Institution - 0110

Phoenix, Arizona, United States, 85016

NOT YET RECRUITING

United States, California

Local Institution - 0114

Loma Linda, California, United States, 92354

NOT YET RECRUITING

United States, California

Local Institution - 0130

Sacramento, California, United States, 95817

NOT YET RECRUITING

United States, California

UCSF Benioff Children's Hospital San Francisco

San Francisco, California, United States, 94158

NOT YET RECRUITING

United States, Florida

Axiom Clinical Research of Florida

Tampa, Florida, United States, 33609

NOT YET RECRUITING

United States, Florida

Local Institution - 0053

Tampa, Florida, United States, 33612

NOT YET RECRUITING

United States, Illinois

Local Institution - 0093

Chicago, Illinois, United States, 60611

NOT YET RECRUITING

United States, Illinois

Local Institution - 0055

Chicago, Illinois, United States, 60637

NOT YET RECRUITING

United States, Missouri

Washington University

Saint Louis, Missouri, United States, 63110

NOT YET RECRUITING

United States, Ohio

Local Institution - 0091

Cincinnati, Ohio, United States, 45229

NOT YET RECRUITING

United States, Oregon

Local Institution - 0092

Portland, Oregon, United States, 97225

NOT YET RECRUITING

United States, Wisconsin

Local Institution - 0033

Milwaukee, Wisconsin, United States, 53226

NOT YET RECRUITING

Australia, Victoria

Local Institution - 0113

Melbourne, Victoria, Australia, 3052

RECRUITING

Italy, Campania

University of Naples Federico II

Napoli, Campania, Italy, 80131

RECRUITING

Italy, Lombardy

San Raffaele Hospital

Milano, Lombardy, Italy, 20132

RECRUITING

Italy, Roma

Neurological Center Of Latium

Rome, Roma, Italy, 00178

NOT YET RECRUITING

Mexico, DIF

Local Institution - 0078

Mexico City, DIF, Mexico, 04530

RECRUITING

Poland, Greater Poland

University Clinical Hospital in Poznań

Poznań, Greater Poland, Poland, 60-355

RECRUITING

Portugal,

2ca braga

Braga, Portugal, 4710-243

NOT YET RECRUITING

Portugal,

Local Institution - 0105

Coimbra, Portugal, 3000-602

NOT YET RECRUITING

Portugal,

Local Institution - 0104

Lisboa, Portugal, 1169-050

NOT YET RECRUITING

Portugal,

Local Institution - 0102

Porto, Portugal, 4200-319

NOT YET RECRUITING

Romania, Bucharest

Local Institution - 0088

Bucharest, Bucharest, Romania, 022102

RECRUITING

Romania, Bucharest

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, Bucharest, Romania, 041914

NOT YET RECRUITING

Spain, Barcelona [Barcelona]

Local Institution - 0096

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

NOT YET RECRUITING

Spain, Pontevedra [Pontevedra]

Local Institution - 0098

Vigo, Pontevedra [Pontevedra], Spain, 36203

RECRUITING

Spain,

Virgen Macarena University Hospital

Sevilla, Spain, 41009

RECRUITING

Spain,

Hospital University the Policenics The F

Valencia, Spain, 46026

NOT YET RECRUITING

Spain,

Local Institution - 0101

Zaragoza, Spain, 50009

RECRUITING

Taiwan,

National Taiwan University Hospital

Taipei, Taiwan, 10002

NOT YET RECRUITING

Turkey,

Local Institution - 0109

Samsun, Turkey, 55270