A Lactation Study in Women Receiving Treatment With Ozanimod

Description

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.

Conditions

Lactating Women, Breastfed Infants

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Study Overview

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Study Details

Study overview

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.

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

A Lactation Study in Women Receiving Treatment With Ozanimod

Condition
Lactating Women
Intervention / Treatment

-

Contacts and Locations

Las Vegas

PPD Las Vegas Clinical Research Unit, Las Vegas, Nevada, United States, 89113-2228

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2025-06-16