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

RECRUITINGSponsored by Bristol-Myers Squibb
Actively Recruiting
SponsorBristol-Myers Squibb
Started2022-07-15
Est. completion2032-06-30
Eligibility
SexFEMALE
Locations2 sites
View on ClinicalTrials.gov →

NCT05170126

Summary

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.

Eligibility

Sex: FEMALE
Inclusion Criteria:

* Diagnosis of Multiple sclerosis (MS)
* Currently or recently pregnant
* Reside in the United States, Canada or Germany.

Exclusion Criteria:

• Exposure to other S1P therapies, cladribine, or mitoxantrone during the first trimester.

Other protocol-defined inclusion/exclusion criteria apply

Conditions1

Multiple Sclerosis

Locations2 sites

Evidera INC.
Bethesda, Maryland, 20814
Marielle Bassel, Site 0003
Evidera
Bethesda, Maryland, 20814
Marielle Bassel, Site 0001

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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