NCT05170126Recruiting
A Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
ZEPOSIA® (Ozanimod) Pregnancy Registry: A Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women and Their Offspring
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1182 (estimated)
- First submitted
- 22 Dec 2021
- Start date
- 15 Jul 2022
- Primary completion date
- 30 Jun 2032
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Multiple sclerosis
- NCT number
- NCT05170126
What you commit to
- Study type: Observational
- Planned participants: 1182
- From 15 Jul 2022 to the primary completion date, 30 Jun 2032
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Exposure to other S1P therapies, cladribine, or mitoxantrone during the first trimester.
- Other protocol-defined inclusion/exclusion criteria apply
Who the study is looking for
- Diagnosis of Multiple sclerosis (MS)
- Currently or recently pregnant
- Reside in the United States, Canada or Germany.
Sex: Female
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Marienhospital Herne, Klinikum Der Ruhr-Universitaet Bochum Coordinator of this site? Confirm its status | Herne | Germany | Recruiting |
| Evidera Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
| Evidera INC. Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.