A Lactation Study in Women Receiving Treatment With Ozanimod

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-15

Study Completion Date

2026-12-16

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.

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Detailed Description

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Conditions

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Lactating Women Breastfed Infants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lactating women receiving treatment with Ozanimod and their infants

Group Type EXPERIMENTAL

Breast milk, plasma, and blood samples

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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Breast milk, plasma, and blood samples

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.

Intervention Type DIAGNOSTIC_TEST

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No