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A Lactation Study in Women Receiving Treatment With Ozanimod

NCT06181630 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2025-12-02

No results posted yet for this study

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.

Conditions

  • Lactating Women
  • Breastfed Infants

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-15
Primary Completion
2026-12-16
Completion
2026-12-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06181630 on ClinicalTrials.gov