A Lactation Study in Women Receiving Treatment With Ozanimod

Withdrawn before enrolling · Phase 4

Conditions studied: Lactating Women, Breastfed Infants

In brief

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.

Key facts

Study ID

NCT06181630

Run by

Bristol-Myers Squibb

People needed

0

Starts

2025-11-15

Expected to finish

2026-12-16

Last updated by the study team

2025-12-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• PPD Las Vegas Clinical Research Unit — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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