What is bimekizumab studying for breastfeeding mothers?

This study is evaluating how much bimekizumab is present in mature breast milk from mothers who are already receiving this medication. Understanding the concentration helps to assess the exposure of breastfeeding infants to the drug. The research is sponsored by UCB Biopharma SRL and focuses on mothers treated for conditions like psoriasis and arthritis.

Who may be eligible for this study?

Women aged 18 or older who are breastfeeding and receiving bimekizumab treatment prescribed by their doctor may be eligible. Participants must not be pregnant or planning pregnancy during the study and need to have been on bimekizumab for at least 12 weeks after delivery. Please review eligibility criteria for more details.

Is there any cost to participate in this clinical trial?

Study-related care, including any study procedures and visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs related to attending study visits.

Actively Recruiting

Phase 1

Age: 18Years +

FEMALE

ID06888193

A Multicenter Open-label, Prospective Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx4 Bimekizumab

Led by UCB Biopharma SRL · Updated on 2026-05-01

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the concentration of bimekizumab, a medication used for conditions like moderate to severe plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and hidradenitis suppurativa, in mature breast milk from mothers receiving this treatment. This phase 1 study aims to understand how much of this drug is present in breast milk to inform safety and care decisions for breastfeeding mothers. The study involves breastfeeding mothers who are already receiving commercial bimekizumab as prescribed by their doctors. Participants will continue their treatment as usual while the research team collects breast milk samples on multiple days throughout the study, including days 1, 2, 3, 5, 7, 9, 11, 13, 15, 29, and 57, to measure bimekizumab levels. The study is open-label and prospective, meaning participants and researchers know the treatment being taken. During the study, participants will provide breast milk samples at specified times, and researchers will estimate the infants dosage and relative intake of bimekizumab from breastfeeding. The study will also monitor any treatment-emergent adverse events for the mother from consent through about 17 weeks. Participation requires ongoing breastfeeding and continuing treatment, with careful monitoring throughout the sampling period and follow-up safety contact.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

FEMALE

Eligibility Criteria

You may qualify if you...

Female participants aged 18 years or older at the time of consent
Currently treated with commercial bimekizumab as prescribed by their physician
Breastfeeding and intending to continue breastfeeding throughout the sampling period
Decision to treat with bimekizumab and to breastfeed made independently before consenting to the study
On bimekizumab treatment for at least 12 weeks after delivery before sampling
Not pregnant and not planning to become pregnant during the study

You will not qualify if you...

Any medical, obstetrical, or psychiatric condition that could compromise participation as judged by the Investigator
Infant has any physical abnormality or medical history that may affect study participation
History of chronic alcohol or drug abuse within the past year
History of breast implants, breast augmentation, or breast reduction surgery
Plans for surgical intervention during the screening or sampling period (except tubal ligation)
Participation in another investigational medicinal product or device study within the past 6 months, except specific allowed studies
Previous participation in this study's sampling period

Research Team

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