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Trial ID IM047-050  |   NCT06408259

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

Summary

  • Phase 3
  • Male and Female Gender icon
  • 10-17
    Age Range
  • 19
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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).

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Has a diagnosis of multiple sclerosis (MS) as defined by the 2017 revision of the McDonald Criteria with a relapsing remitting course of disease.
    1. Meets at least 1 of the following criteria for disease activity:
      1. At least 1 MS relapse/attack in the previous year prior to screening.
        1. At least 2 MS relapses/attacks in the previous 2 years prior to screening.
          1. Evidence of 1 or more gadolinium-enhancing (GdE) lesions on magnetic resonance imaging (MRI) within 6 months prior to baseline (including screening MRI).
          2. Has an Expanded Disability Status Scale (EDSS) score of 0 to 5.5, both inclusive.

            Exclusion Criteria

            Exclusion Criteria Icon
            :
            • Diagnosis of progressive forms of MS.
              1. Active or chronic disease of the immune system other than MS.
                1. Clinically relevant cardiovascular, hepatic, neurological other major systematic disease.
                  Additional Information *
                  • Other protocol-defined Inclusion/Exclusion criteria apply.

                    Treatment Options

                    Study Arms

                    ASSIGNED INTERVENTION

                    Study Arms

                    Active Comparator: Fingolimod

                    ASSIGNED INTERVENTION
                    • Drug: Fingolimod
                    • Other: Placebo

                    Study Arms

                    Experimental: Ozanimod

                    ASSIGNED INTERVENTION
                    • Drug: Ozanimod
                    • Other: Placebo
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