Examining the safety of ozanimod in pregnant women with multiple sclerosis
Official title: ZEPOSIA® (Ozanimod) Pregnancy Registry: A Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
Run by Bristol-Myers Squibb · NCT05170126 · Data updated 2026-11-12
This study is trying to see how safe the medication ozanimod is for pregnant women with multiple sclerosis and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Sex | Women only |
| Enrollment | 1182 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 3 sites (Bethesda, Maryland and 2 other locations) |
| Status | Recruiting |
| Started | July 15, 2022 |
| Main results expected | June 30, 2032 |
| Study ends | June 30, 2032 |
| Registry record updated | November 20, 2025 |
| Trial ID | NCT05170126 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women diagnosed with multiple sclerosis who have been exposed to ozanimod.
✕Probably not a fit
Patients who are not pregnant or who have been exposed to other S1P therapies during the first trimester may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to gather data on the safety and outcomes for mothers and their infants who have been exposed to ozanimod during pregnancy. It focuses on understanding the maternal, fetal, and infant health implications of ozanimod exposure, allowing healthcare providers and patients to make informed decisions regarding treatment options during pregnancy. Participants must have a diagnosis of multiple sclerosis and be currently or recently pregnant, residing in the United States, Canada, or Germany.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety of ozanimod for pregnant women with multiple sclerosis, guiding treatment decisions.
How similar studies have gone: While this study focuses on a specific medication during pregnancy, similar observational studies have provided valuable safety data for other treatments in pregnant populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Evidera INC.
Bethesda, Maryland, United States Recruiting -
Evidera
Bethesda, Maryland, United States Recruiting -
Marienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum
Herne, Germany Recruiting
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.