Assessing Bimekizumab Levels in Breast Milk of Nursing Mothers
A Multicenter Open-label, Prospective Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
This study tests how much of the medication bimekizumab is found in the breast milk of mothers who have been using it for at least 12 weeks after giving birth to see if it's safe for their babies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | UCB Pharma Industry-sponsored |
| Drugs / interventions | bimekizumab |
| Locations | 12 sites (Santa Monica, California and 11 other locations) |
| Trial ID | NCT06888193 on ClinicalTrials.gov |
What this trial studies
This study evaluates the concentration of bimekizumab, a treatment for various inflammatory conditions, in the breast milk of mothers who are receiving this medication. Participants must be breastfeeding and have been on bimekizumab treatment for at least 12 weeks post-delivery. The study aims to ensure that the medication is safe for nursing infants by measuring its levels in mature breast milk. The findings could provide important insights into the implications of bimekizumab use during breastfeeding.
Who should consider this trial
Good fit: Ideal candidates are breastfeeding mothers who have been treated with bimekizumab for at least 12 weeks after delivery.
Not a fit: Patients who are not breastfeeding or who have not been on bimekizumab treatment for the required duration will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical information on the safety of bimekizumab for breastfeeding mothers and their infants.
How similar studies have performed: While studies assessing drug concentrations in breast milk are common, this specific investigation into bimekizumab is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Study participant must be at least 18 years of age at the time of signing the informed consent. * Study participant is being treated with commercial bimekizumab per locally approved prescribing information and in accordance with her treating physician. * Study participant is breastfeeding and intends to breastfeed throughout the Sampling Period. * The decision to treat with bimekizumab and to breastfeed is made independently from and prior to the study participant consenting to participate in the study. * Study participant must be on bimekizumab treatment for at least 12 weeks after delivery and since starting/restarting/continuing bimekizumab prior to sampling (prior to start of the Sampling Period). * A female study participant is eligible to participate if she is not pregnant and does not plan to become pregnant during the study. Exclusion Criteria: * Study participant has any medical, obstetrical, or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. * The infant has any abnormality noted on physical examination or medical history that, in the opinion of the Investigator, may jeopardize or compromise study participation. * Study participant has a history of chronic alcohol or drug abuse within the previous last year. * Study participant has history of breast implants, breast augmentation, or breast reduction surgery. * Study participant plans a surgical intervention during the Screening Period and Sampling Period or anticipates having surgery while participating in the Sampling Period (does not apply to tubal ligation). * Study participant or her infant has participated in another study of an investigational medicinal product (IMP) (and/or an investigational device) within the previous 6 months or is currently participating in another study of an IMP (and/or an investigational device), unless the study is UCB PS0036 or a bimekizumab registry study. * Study participant or her infant has previously participated (ie, entered the sampling period) in this study.
Where this trial is running
Santa Monica, California and 11 other locations
- Up0122 105 — Santa Monica, California, United States (Recruiting)
- Up0122 103 — South Miami, Florida, United States (Recruiting)
- Up0122 102 — Durham, North Carolina, United States (Recruiting)
- Up0122 101 — Milwaukee, Wisconsin, United States (Recruiting)
- Up0122 202 — Calgary, Canada (Recruiting)
- Up0122 201 — Vancouver, Canada (Recruiting)
- Up0122 301 — Freiburg im Breisgau, Germany (Recruiting)
- Up0122 303 — Herne, Germany (Recruiting)
- Up0122 501 — Barcelona, Spain (Recruiting)
- Up0122 502 — Barcelona, Spain (Recruiting)
- Up0122 602 — Lausanne, Switzerland (Recruiting)
- Up0122 601 — Sankt Gallen, Switzerland (Recruiting)
Study contacts
- Study coordinator: UCB Cares
- Email: ucbcares@ucb.com
- Phone: 1-844-599-2273 (USA)
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.