A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
Observational · No treatment assigned · 1 site · Bristol-Myers Squibb
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Age range not stated in the record
- Women only
Some of the main requirements, copied from the record:
- Currently or recently pregnant
- Diagnosis of UC
- Resident of country where ozanimod is prescribed for the treatment of UC
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 1182 participants are expected to take part.
- Start date: 2026-04-21.
- Main results expected around 2034-06-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Event rate of Major Congenital Malformations (MCM) (Up to 12 months)
In the researchers’ words
The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Bristol-Myers Squibb |
| Enrollment | 1182 (estimated) |
| Start date | 2026-04-21 |
| Primary completion (est.) | 2034-06-30 |
| First posted | 2023-07-20 |
| Last updated | 2026-06-15 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT05953402 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: * Currently or recently pregnant * Diagnosis of UC * Resident of country where ozanimod is prescribed for the treatment of UC Exclusion Criteria: * Exposure to other S1P therapies at any time during pregnancy Other protocol-defined eligibility criteria apply.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| PPD Virtual - PPD - US | Wilmington, North Carolina | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.