A Lactation Study in Women Receiving Treatment With Ozanimod

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 4

Conditions: Lactating Women; Breastfed Infants

Treatments: Diagnostic Test: Breast milk, plasma, and blood samples

Study type: Interventional

Funder types: Industry

Identifiers

NCT06181630

IM047-030

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Lactating women receiving treatment with Ozanimod and their infants

Experimental group

Treatment:

Diagnostic Test: Breast milk, plasma, and blood samples