A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

Launched by UCB BIOPHARMA SRL · Mar 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how much of the medication bimekizumab appears in the breast milk of mothers who are being treated for conditions like moderate to severe plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and hidradenitis suppurativa. The main goal is to understand the concentration of this drug in mature breast milk, which can help doctors and mothers make informed decisions about breastfeeding while on this treatment.

To participate in the trial, women need to be at least 18 years old, currently receiving bimekizumab treatment, and breastfeeding, with plans to continue breastfeeding during the study. They should have been on bimekizumab for at least 12 weeks after giving birth. It's important that they are not pregnant and do not plan to become pregnant during the study. Participants will be monitored for the concentration of the medication in their breast milk, which helps ensure both mother and baby’s health is prioritized. Please note that this study is not yet recruiting participants, so it's not currently possible to join.

Gender

FEMALE

Eligibility 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.