Ozanimod for Breastfeeding

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Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Bristol-Myers Squibb

Must be taking: Ozanimod

Disqualifiers: Pregnancy, Not breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

16 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since the study involves participants already being treated with ozanimod, it seems you may continue taking it if you are already on it.

What is the purpose of this trial?

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.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This study is for breastfeeding women who have given birth to a single, full-term baby (at least 37 weeks) and are between 2 weeks to 12 months postpartum. They should be planning on or currently taking ozanimod as per local medical guidelines.

Inclusion Criteria

I have given birth to a full-term baby.

My baby was born with a weight above the lower 10% for their gestational age.

I am a woman currently taking or planning to take ozanimod as prescribed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Lactating women receive treatment with Ozanimod to assess drug concentrations in breast milk

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including effects on breastfed infants

4 weeks

Treatment Details

Interventions

• Ozanimod

Trial Overview The trial aims to measure the levels of ozanimod, a drug used for certain autoimmune conditions, and its main byproducts in breast milk. It also looks at how these substances might affect the breastfed infants.

Participant Groups

Group I: Lactating women receiving treatment with Ozanimod and their infants Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania