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  • NCT05170126

Recruiting

A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring - IM047-003

Updated: 17 April, 2025   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.
Print this page IM047-003
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Trial Details

  • Gender(s)

  • N/A

    Age Range

  • 3

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Ozanimod-exposed
Unexposed comparator cohort with MS
Unexposed comparator cohort without MS

Key Eligibility Criteria

Inclusion Criteria: - Diagnosis of Multiple sclerosis (MS) - Currently or recently pregnant - Reside in a country where ozanimod is prescribed for treatment of MS Exclusion Criteria: - Diagnostic prenatal test results known prior to first contact with the Registry Coordination Center (RCC) - Exposure to known teratogens and/or investigational medications during pregnancy Other protocol-defined inclusion/exclusion criteria apply

If you want to report a side effect, you can report directly to the Danish Medicines Agency via the website www.meldenbivirkning.dk
We recommend that you also contact BMS to report side effects.
Side effects and other reportable events are defined here
Report side effects or product quality complaints: Medical Information

466-DK-2200001