Ozanimod in pregnancy for ulcerative colitis: how it affects moms and babies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study examining the relationship between ozanimod exposure during pregnancy and maternal, fetal, and infant outcomes in women with ulcerative colitis. It does not specify an intervention and will analyze data from pregnancies where ozanimod is prescribed for UC. Eligible participants are currently or recently pregnant adults with UC who live in countries where ozanimod is approved, excluding those with prior exposure to other S1P therapies during pregnancy. Lead sponsor is Bristol-Myers Squibb, with the study conducted virtually via PPD in the United States (Wilmington, NC). Findings may provide insights into safety and outcomes associated with ozanimod use in pregnancy.

Why it matters

Who can join: the full rules

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.

Where it's running

• PPD Virtual - PPD - US
  Wilmington, North Carolina, United States Recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.