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Breast milk drug study withdrawn before start

NCT ID NCT06181630

Knowledge-focused Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study was designed to measure how much of the drug ozanimod passes into breast milk and to check for any effects on breastfed infants. It planned to include lactating women already taking ozanimod for medical reasons. However, the study was withdrawn before enrolling any participants, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breastfed infants Lactating women

Contacts and locations

Locations

  • PPD Las Vegas Clinical Research Unit

    Las Vegas, Nevada, 89113-2228, United States