Status:
WITHDRAWN
A Lactation Study in Women Receiving Treatment With Ozanimod
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Lactating Women
Breastfed Infants
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the concentrations of ozanimod and its major metabolites in breast milk and the effects on breastfed infants.
Eligibility Criteria
Inclusion
- Adult female participant is already planning or currently being treated with ozanimod per the current locally approved prescribing information.
- Adult female participant has delivered a single normal-term infant (at least 37 weeks gestation).
- Adult female participant is at least 2 weeks postpartum but not more than 12 months postpartum by Study Visit 1.
- Infant participant has normal weight for gestational age (above tenth percentile) at birth.
Exclusion
- Adult participant is pregnant, planning to become pregnant, or are of childbearing potential and not using an effective contraceptive method.
- Adult participant is not breastfeeding or pumping milk.
- Adult participant has received any live vaccinations within 4 weeks prior to the start of ozanimod treatment.
- Infant participant was born less than 37 weeks gestation
- Other protocol-defined criteria apply.
Key Trial Info
Start Date :
November 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06181630
Start Date
November 15 2025
End Date
December 16 2026
Last Update
December 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
PPD Las Vegas Clinical Research Unit
Las Vegas, Nevada, United States, 89113-2228