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

NCT05953402 | Recruiting

• 1 other identifier: IM047-026
• Study Type: observational
• Target: 1,182
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Event rate of Major Congenital Malformations (MCM)

  Up to 12 months

Secondary Outcomes (14)

• Event rate of minor congenital malformations

  Up to 12 months

• Event rate of pre-eclampsia

  Up to 9 months

• Event rate of eclampsia

  Up to 9 months

• Event rate of Spontaneous Abortion (SAB)

  Up to 9 months

• Event rate of stillbirth

  Up to 9 months

Study Arms (3)

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Currently or recently pregnant
• Diagnosis of UC
• Resident of country where ozanimod is prescribed for the treatment of UC

You may not qualify if:

• Exposure to other S1P therapies at any time during pregnancy
• Other protocol-defined eligibility criteria apply.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

PPD Virtual - PPD - US

Wilmington, North Carolina, 28401-3331, United States

RECRUITING

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 21 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 20, 2023
• Study Start: April 21, 2026
• Primary Completion (Estimated): June 30, 2034
• Study Completion (Estimated): June 30, 2034
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

US (1)