Assessing ozanimod levels in breast milk of lactating women
A Phase IV Postmarketing Study Evaluating Ozanimod Concentrations in the Breast Milk of Lactating Women Receiving Ozanimod Therapeutically
This study is testing how much ozanimod is in the breast milk of new mothers who are taking this medication to see if it's safe for their babies.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (Las Vegas, Nevada) |
| Trial ID | NCT06181630 on ClinicalTrials.gov |
What this trial studies
This study evaluates the concentrations of ozanimod and its major metabolites in the breast milk of women who are receiving treatment with this medication. It aims to understand the potential effects of ozanimod on breastfed infants by analyzing breast milk, plasma, and blood samples. The study focuses on women who are at least two weeks postpartum and have delivered a normal-term infant. The findings could provide valuable insights into the safety of ozanimod for breastfeeding mothers and their infants.
Who should consider this trial
Good fit: Ideal candidates are adult women who are currently being treated with ozanimod and are at least two weeks postpartum with a normal-term infant.
Not a fit: Patients who are not breastfeeding or have infants born prematurely may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help ensure the safety of ozanimod for lactating women and their breastfed infants.
How similar studies have performed: While studies on drug concentrations in breast milk are common, this specific investigation into ozanimod is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Las Vegas, Nevada
- PPD Las Vegas Clinical Research Unit — Las Vegas, Nevada, United States (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.