Recruiting

Ozanimod

Sponsor:

Bristol-Myers Squibb

Code:

NCT05953402

Conditions

Ulcerative Colitis

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05953402

Start date

Apr 21, 2026

Status verified date

Jun, 2026

Completion date

Jun 30, 2034

Anticipated

Primary completion date

Jun 30, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1182 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Event rate of Major Congenital Malformations (MCM) [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Central contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

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

Locations

PPD Virtual - PPD - US

Recruiting

Wilmington, North Carolina, United States, 28401-3331

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • ZEPOSIA®
  • Ozanimod
  • Pregnancy
  • Sphingosine-1-phosphate (S1P) therapies
  • Inflammatory Bowel Disease
  • IBD
  • Ulcerative Colitis
  • UC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-06-15.