RecruitingNot Applicable

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

United States, Germany1,182 participantsStarted 2022-07-15

Plain-language 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.

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Major congenital malformations

Timeframe: Up to first year of life

Trial details

NCT IDNCT05170126

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2032-06-30

Contact for this trial

BMS Study Connect Contact Center www.BMSStudyConnect.com

855-907-3286 Clinical.Trials@bms.com

View on ClinicalTrials.gov More Multiple Sclerosis trials