A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
Recruiting · NCT05953402 · Observational (researchers observe without assigning treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →What this trial is about
The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.
Who can take part
Age range
No age limits stated
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
- ther protocol-defined eligibility criteria apply.
Where it is running
1 location listed across 1 US state.
- PPD Virtual - PPD - US - Wilmington, North Carolina, United States