Ulcerative ColitisNCT05953402
A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
An observational study of Ulcerative Colitis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ulcerative Colitis
- How many people
- 1,182 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2026to 30 Jun 2034
- How long will I take part?
- 21 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include women of any age who i) are currently or recently have been pregnant; ii) have a diagnosis of UC; iii) reside in a country where ozanimod is prescribed for the treatment of UC; iv) provide consent to participate as well as medical releases for their Healthcare Providers (HCPs) to provide data to the registry; and v) meet the criteria for inclusion.
Who may be able to join
- Currently or recently pregnant
- Diagnosis of UC
- Resident of country where ozanimod is prescribed for the treatment of UC
Who cannot join
- Exposure to other S1P therapies at any time during pregnancy
- Other protocol-defined eligibility criteria apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
First line of the email MUST contain the NCT# and Site #. contact
United States1 site, 1 recruiting
- Recruiting
PPD Virtual - PPD - US
Wilmington, North Carolina, 28401-3331
Site 0001
About this study
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
The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.
- Conditions
- Ulcerative Colitis
- Keywords
- ZEPOSIA®, Ozanimod, Pregnancy, Sphingosine-1-phosphate (S1P) therapies, Inflammatory Bowel Disease, IBD, Ulcerative Colitis, UC
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ozanimod-exposed participants with UC | Pregnant women with a diagnosis of UC who are exposed to ozanimod at any time during pregnancy | |
| Conventional therapy-exposed participants with UC | Pregnant women with a diagnosis of UC who are exposed to conventional therapies (aminosalicylates and/or thiopurines) but not exposed to ozanimod, other S1P therapies, or advanced therapies for UC (biologics and/or small molecules) at any time during pregnancy | |
| Advanced therapy-exposed participants with UC | Pregnant women with a diagnosis of UC who are exposed to advanced therapies for UC (biologics and/or small molecules) but not exposed to ozanimod or other S1P therapies at any time during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event rate of Major Congenital Malformations (MCM)
Measured: Up to 12 months
Secondary outcomes (14)
Event rate of minor congenital malformations
Measured: Up to 12 months
Event rate of pre-eclampsia
Measured: Up to 9 months
Event rate of eclampsia
Measured: Up to 9 months
Event rate of Spontaneous Abortion (SAB)
Measured: Up to 9 months
Event rate of stillbirth
Measured: Up to 9 months
Event rate of elective termination
Measured: Up to 9 months
Event rate of preterm birth
Measured: Up to 9 months
Event rate of Small for Gestational Age (SGA)
Measured: Up to 12 months
Event rate of postnatal growth deficiency
Measured: Up to 12 months
Event rate of infant developmental deficiency
Measured: Up to 12 months
Event rate of perinatal death
Measured: Up to 10 months
Event rate of neonatal death
Measured: Up to 1 month
Event rate of infant death
Measured: Up to 12 months
Event rate of serious or opportunistic infant infections
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start21 Apr 2026
- Primary completion30 Jun 2034 (estimated)
- Study completion30 Jun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,182 participants (estimated)
- Target duration
- 21 Months
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953402
- Sponsor's protocol ID
- IM047-026
- Status last verified
- Jun 2026
- First submitted
- 12 Jul 2023
- Last updated
- 15 Jun 2026
- Results posted
- No