Clinical trial Recruiting at 3 sites Observational Women only

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.

More Multiple Sclerosis trials

Quick facts

Study typeObservational
SexWomen only
Enrollment1182 (estimated)
SponsorBristol-Myers Squibb
Industry-sponsored
Locations3 sites (Bethesda, Maryland and 2 other locations)
StatusRecruiting
StartedJuly 15, 2022
Main results expectedJune 30, 2032
Study endsJune 30, 2032
Registry record updatedNovember 20, 2025
Trial IDNCT05170126 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.