WITHDRAWN

A Lactation Study in Women Receiving Treatment With Ozanimod

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-11-15
Study Completion:2026-12-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:WITHDRAWN

Study ID

NCT06181630

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult female participant is already planning or currently being treated with ozanimod per the current locally approved prescribing information.
  2. * Adult female participant has delivered a single normal-term infant (at least 37 weeks gestation).
  3. * Adult female participant is at least 2 weeks postpartum but not more than 12 months postpartum by Study Visit 1.
  4. * Infant participant has normal weight for gestational age (above tenth percentile) at birth.
  1. * Adult participant is pregnant, planning to become pregnant, or are of childbearing potential and not using an effective contraceptive method.
  2. * Adult participant is not breastfeeding or pumping milk.
  3. * Adult participant has received any live vaccinations within 4 weeks prior to the start of ozanimod treatment.
  4. * Infant participant was born less than 37 weeks gestation

Contacts and Locations

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-11-15
Study Completion Date2026-12-16

Study Record Updates

Study Start Date2025-11-15
Study Completion Date2026-12-16

Terms related to this study

Keywords Provided by Researchers

  • Ozanimod
  • BMS-986374

Additional Relevant MeSH Terms

  • Lactating Women
  • Breastfed Infants