Ozanimod for Breastfeeding
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to measure the levels of the drug ozanimod and its main byproducts in breast milk and assess their potential effects on breastfed babies. Ozanimod commonly treats autoimmune conditions like multiple sclerosis. The trial seeks women who are breastfeeding, have given birth to a full-term baby, and are already using ozanimod or planning to start. Participants must be between two weeks and a year postpartum. The study will help determine the safety of breastfeeding while on this medication. As a Phase 4 trial, this research focuses on understanding how an FDA-approved and effective treatment benefits more patients, offering valuable insights for breastfeeding mothers.
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 safety track record for this treatment?
Research shows that ozanimod is usually well-tolerated, but its safety for breastfeeding mothers remains unclear. Some studies have found that ozanimod and its breakdown products can appear in the breast milk of animals, raising concerns about possible effects on breastfed babies.
Currently, clear information on these effects is lacking. Therefore, experts suggest exercising caution if breastfeeding, especially with newborns or premature babies.
Ozanimod is already approved for other uses, indicating its general safety. However, without specific information on breastfeeding, discussing the risks and benefits with a healthcare provider is important.12345Why are researchers enthusiastic about this study treatment?
Unlike the standard of care for lactating women, which typically involves managing conditions without specific medications due to potential risks for infants, Ozanimod offers a new approach. Ozanimod is unique because it works by selectively modulating the immune system, specifically targeting the sphingosine 1-phosphate (S1P) receptor. This targeted action can potentially reduce inflammation with fewer side effects, making it a promising option for mothers needing treatment while breastfeeding. Researchers are excited about Ozanimod because it opens the possibility of safely treating conditions in lactating women without compromising infant health.
What is the effectiveness track record for Ozanimod?
Research has shown that ozanimod effectively treats conditions like multiple sclerosis and ulcerative colitis. It alters the immune system to reduce inflammation, helping to control symptoms. This trial studies lactating women receiving ozanimod and their infants to better understand its effects on breastfeeding and breastfed babies. Although ozanimod is generally safe, its effects on breastfeeding remain under evaluation. Until more information becomes available, caution is advised when using ozanimod during breastfeeding, particularly with newborns or premature babies.16789
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Lactating women receive treatment with Ozanimod to assess drug concentrations in breast milk
Follow-up
Participants are monitored for safety and effectiveness after treatment, including effects on breastfed infants
What Are the Treatments Tested in This Trial?
Interventions
- Ozanimod
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
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