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

Last updated: April 7, 2025
Sponsor: Celgene
Overall Status: Active - Recruiting

Phase

3

Condition

Multiple Sclerosis

Memory Loss

Scar Tissue

Treatment

Fingolimod

Ozanimod

Placebo

Clinical Study ID

NCT06408259
IM047-050
2022-501332-42
U1111-1281-5433
  • Ages 10-17
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Has a diagnosis of multiple sclerosis (MS) as defined by the 2017 revision of theMcDonald 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

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 systematicdisease.

  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Total Participants: 194
Treatment Group(s): 3
Primary Treatment: Fingolimod
Phase: 3
Study Start date:
April 25, 2025
Estimated Completion Date:
July 13, 2036

Connect with a study center

  • Local Institution - 0083

    Napoli, Campania 80131
    Italy

    Site Not Available

  • University of Naples Federico II

    Napoli, Campania 80131
    Italy

    Active - Recruiting

  • Ospedale San Raffaele

    Milano, Lombardia 20132
    Italy

    Active - Recruiting

  • Local Institution - 0086

    Rome, Roma 00178
    Italy

    Site Not Available

  • Neurological Center Of Latium

    Rome, Roma 00178
    Italy

    Active - Recruiting

  • Local Institution - 0078

    Mexico City, DIF 04530
    Mexico

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznań, Wielkopolskie 60-355
    Poland

    Active - Recruiting

  • Local Institution - 0088

    Bucharest, București 022102
    Romania

    Site Not Available

  • Prof. Dr. Alexandru Obregia Psychiatry Hospital

    Bucharest, București 041914
    Romania

    Active - Recruiting

  • Local Institution - 0094

    València, 46026
    Spain

    Site Not Available

  • Local Institution - 0101

    Zaragoza, 50009
    Spain

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Local Institution - 0109

    Samsun, 55270
    Turkey

    Site Not Available

  • Local Institution - 0130

    Sacramento, California 95817
    United States

    Site Not Available

  • UCSF Benioff Children's Hospital San Francisco

    San Francisco, California 94158
    United States

    Site Not Available

  • Axiom Clinical Research of Florida

    Tampa, Florida 33609
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33612
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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