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

NCT05953402 — Recruiting, 1182 participants, Bristol-Myers Squibb

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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

Registry	NCT05953402
Status	Recruiting
Study type	Observational
Enrollment	1182 (Estimated)
Sponsor	Bristol-Myers Squibb (Industry)
Conditions	Ulcerative Colitis
Dates	start 2026-04-21, primary completion 2034-06-30 (estimated), completion 2034-06-30 (estimated), first posted 2023-07-20, last updated 2026-06-15
Locations	1 site in United States

-Summary

The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.

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+Arms and interventions

Arm	Type	Interventions	Description
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

+Outcome measures

Primary outcomes

Event rate of Major Congenital Malformations (MCM) [Up to 12 months]

Secondary outcomes

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]
Event rate of elective termination [Up to 9 months]
Event rate of preterm birth [Up to 9 months]
Event rate of Small for Gestational Age (SGA) [Up to 12 months]
Event rate of postnatal growth deficiency [Up to 12 months]
Event rate of infant developmental deficiency [Up to 12 months]
Event rate of perinatal death [Up to 10 months]
Event rate of neonatal death [Up to 1 month]
Event rate of infant death [Up to 12 months]
Event rate of serious or opportunistic infant infections [Up to 12 months]

+Eligibility

Sex: Female

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)

Facility	City	Country	Status
PPD Virtual - PPD - US	Wilmington, North Carolina	United States	Recruiting

+Investigators

Bristol-Myers Squibb, Study director, Bristol-Myers Squibb