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NCT06408259 | NOT YET 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 : 2024-07-09
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, 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

University of South Florida

Tampa, Florida, United States, 33612

Not yet recruiting

United States, Missouri

Washington University

Saint Louis, Missouri, United States, 63110

Not yet recruiting

United States, Wisconsin

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226