NCT05953402Recruiting
A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
ZEPOSIA® (Ozanimod) Ulcerative Colitis Pregnancy Registry: a Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women With Ulcerative Colitis and Their Offspring
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1182 (estimated)
- First submitted
- 12 Jul 2023
- Start date
- Apr 2026
- Primary completion date
- Jun 2034
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Ulcerative colitis
- NCT number
- NCT05953402
What you commit to
- Study type: Observational
- Planned participants: 1182
- From Apr 2026 to the primary completion date, Jun 2034
- 1 site in 1 country
- 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 at any time during pregnancy
- Other protocol-defined eligibility criteria apply.
Who the study is looking for
- Currently or recently pregnant
- Diagnosis of UC
- Resident of country where ozanimod is prescribed for the treatment of UC
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PPD Virtual - PPD - US Coordinator of this site? Confirm its status | Wilmington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.