A Lactation Study in Women Receiving Treatment With Ozanimod

Study Overview
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Brief Summary
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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.

Official Title
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A Phase IV Postmarketing Study Evaluating Ozanimod Concentrations in the Breast Milk of Lactating Women Receiving Ozanimod Therapeutically

Conditions
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Lactating Women, Breastfed Infants

Intervention / Treatment
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* Diagnostic Test: Breast milk, plasma, and blood samples


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactating women receiving treatment with Ozanimod and their infants<br> | Diagnostic Test: Breast milk, plasma, and blood samples<br>* Although this study is non- interventional regarding treatment with ozanimod, the study is considered interventional due to the collection of breast milk and plasma from the lactating women and blood samples from their breastfed infants and the additional diagnostic and monitoring procedures required for the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 daily infant dose |  | Predose; Up to 24 hours post dose | 
| Drug relative infant dose |  | Predose; Up to 24 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up to approximately 5 months | 
| 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 | 
| Plasma trough observed plasma concentration at the end of a dosing interval at steady state (Ctrough) |  | Predose; Up to 12 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 | 
| Time to reach Cmax (Tmax) |  | Predose; Up to 24 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ozanimod, BMS-986374