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

NCT05953402 · tracked via the Priya Life Science USA tracker

Sponsor

Bristol-Myers Squibb

Phase

Observational

Started

2026-04-21

Last updated

2026-06-15

Condition(s) studied

Ulcerative Colitis

Study summary

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

Eligibility

Sex

FEMALE

Min age

—

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
PPD Virtual - PPD - US	Wilmington	North Carolina	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05953402 on ClinicalTrials.gov ↗ ← All trials in the USA