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Trial ID IM047-003  |   NCT05170126

A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring

Summary

  • Female Gender icon
  • N/A
    Age Range
  • 3
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to provide information on maternal, fetal, and infant outcomes following exposure of ozanimod during pregnancy so that participants and physicians can weigh the benefits and risks of exposure to the pharmaceutical during pregnancy and make informed treatment decisions.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Diagnosis of Multiple sclerosis (MS)
    1. Currently or recently pregnant
      1. Reside in the United States, Canada or Germany.

        Exclusion Criteria

        Exclusion Criteria Icon
        : • Exposure to other S1P therapies, cladribine, or mitoxantrone during the first trimester. Other protocol-defined inclusion/exclusion criteria apply
        Additional Information *

        Treatment Options

        Study Arms

        ASSIGNED INTERVENTION

        Study Arms

        Comparator-exposed participants

        ASSIGNED INTERVENTION

        Study Arms

        Ozanimod-exposed participants

        ASSIGNED INTERVENTION

        Study Arms

        Unexposed participants

        ASSIGNED INTERVENTION
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