A Lactation Study in Women Receiving Treatment With Ozanimod

Phase 4

Recruiting

• Conditions: Breastfed Infants; Lactating Women
• Interventions: Diagnostic Test: Breast milk, plasma, and blood samples

• Registration Number: NCT06181630
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2023-12-13
• Study First Posted: 2023-12-26
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-03
• Last Update Posted: 2025-06-04
• Study Start: 2025-06-17
• Primary Completion: 2026-12-16
• Study Completion: 2026-12-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lactating women receiving treatment with Ozanimod and their infants	Breast milk, plasma, and blood samples	-

Primary Outcome Measures

Name	Time	Method
Drug daily infant dose	Predose; Up to 24 hours post dose
Average concentration at steady state (Css-avg) in breast milk	Predose; Up to 24 hours post dose
Area under the concentration-time curve over the dosing interval (AUCtau) in breast milk	Predose; Up to 24 hours post dose
Drug relative infant dose	Predose; Up to 24 hours post dose

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs)	Up to approximately 5 months
Plasma trough observed plasma concentration at the end of a dosing interval at steady state (Ctrough)	Predose; Up to 12 hours post dose
Number of participants with clinical laboratory abnormalities	Up to approximately 5 months
Number of participants with vital sign abnormalities	Up to approximately 5 months
Number of participants with physical examination abnormalities	Up to approximately 5 months
Time to reach Cmax (Tmax)	Predose; Up to 24 hours post dose
Maximum observed concentration in breast milk over the dosing interval (Cmax)	Predose; Up to 24 hours post dose
Minimum observed concentration in breast milk over the dosing interval (Cmin)	Predose; Up to 24 hours post dose

Trial Locations

Locations (1)

PPD Las Vegas Clinical Research Unit; 🇺🇸 Las Vegas, Nevada, United States