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Ícono de BMS, studio Reclutando

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ID del estudio IM047-050  |   NCT06408259

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

Resumen

  • Phase 3
  • Ícono de género masculino y femenino
  • 10-17
  • 19
  • Ícono de BMS, studio Reclutando
    Recruiting

Descripción general

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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Criterios clave de elegibilidad

Criterios de inclusión

Criterios de inclusión Icon
:
  • 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.

            Criterios de exclusión

            Criterios de exclusión 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.
                  Información Adicional *
                  • Other protocol-defined Inclusion/Exclusion criteria apply.

                    Opciones de tratamiento

                    Brazos del estudio

                    INTERVENCIÓN ASIGNADA

                    Brazos del estudio

                    Active Comparator: Fingolimod

                    INTERVENCIÓN ASIGNADA
                    • Drug: Fingolimod
                    • Other: Placebo

                    Brazos del estudio

                    Experimental: Ozanimod

                    INTERVENCIÓN ASIGNADA
                    • Drug: Ozanimod
                    • Other: Placebo
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