Study to Measure Bimekizumab Levels in Mature Breast Milk of Mothers Treated With Bimzelx4 Bimekizumab

What this Trial Is About

This research focuses on breastfeeding mothers who are receiving bimekizumab, a treatment for conditions such as moderate to severe plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and hidradenitis suppurativa. The study aims to measure the amount of bimekizumab present in mature human breast milk. It is a phase 1, open-label study sponsored by UCB Biopharma SRL, designed to understand drug exposure through breastfeeding. Participants are women who continue to receive commercially available bimekizumab as prescribed by their physicians. They will be monitored while breastfeeding, with breast milk samples collected on multiple days spanning from Day 1 to Day 57. The study does not alter their treatment but observes the concentration of bimekizumab in breast milk during this sampling period. Throughout the study, researchers will collect breast milk samples on specified days to assess bimekizumab levels and estimate infant exposure. Safety will be monitored by recording any treatment-emergent adverse events in the mothers from the time of consent through follow-up. The total duration of active sampling and monitoring extends to approximately 17 weeks, during which mothers will be observed under the care of their treating physicians.

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