A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring

June 12, 2026 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1182

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain the NCT# and Site #.

Study Locations

  • United States
    • North Carolina
      • Wilmington, North Carolina, United States, 28401-3331
        • Recruiting
        • PPD Virtual - PPD - US
        • Contact:
          • Site 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event rate of Major Congenital Malformations (MCM)
Time Frame: Up to 12 months
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Event rate of minor congenital malformations
Time Frame: Up to 12 months
Up to 12 months
Event rate of pre-eclampsia
Time Frame: Up to 9 months
Up to 9 months
Event rate of eclampsia
Time Frame: Up to 9 months
Up to 9 months
Event rate of Spontaneous Abortion (SAB)
Time Frame: Up to 9 months
Up to 9 months
Event rate of stillbirth
Time Frame: Up to 9 months
Up to 9 months
Event rate of elective termination
Time Frame: Up to 9 months
Up to 9 months
Event rate of preterm birth
Time Frame: Up to 9 months
Up to 9 months
Event rate of Small for Gestational Age (SGA)
Time Frame: Up to 12 months
Up to 12 months
Event rate of postnatal growth deficiency
Time Frame: Up to 12 months
Up to 12 months
Event rate of infant developmental deficiency
Time Frame: Up to 12 months
Up to 12 months
Event rate of perinatal death
Time Frame: Up to 10 months
Up to 10 months
Event rate of neonatal death
Time Frame: Up to 1 month
Up to 1 month
Event rate of infant death
Time Frame: Up to 12 months
Up to 12 months
Event rate of serious or opportunistic infant infections
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2026

Primary Completion (Estimated)

June 30, 2034

Study Completion (Estimated)

June 30, 2034

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM047-026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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