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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
20
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
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 infant's 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 weeks
Participants continue receiving commercially available bimekizumab under the care of their treating physician while breast milk samples are collected to assess bimekizumab concentration.
11 visits on Days 1, 2, 3, 5, 7, 9, 11, 13, 15, 29, and 57
Duration - Up to approximately 17 weeks
Participants are monitored for treatment-emergent adverse events from the time of informed consent up to approximately 17 weeks.
Visits as needed for safety follow-up
Trial Site Locations
Total: 12 locations
1
Up0122 105
Santa Monica, California, United States, 90404
Actively Recruiting
2
Up0122 103
South Miami, Florida, United States, 33155
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3
Up0122 102
Durham, North Carolina, United States, 27710
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4
Up0122 101
Milwaukee, Wisconsin, United States, 53226
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5
Up0122 202
Calgary, Canada
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6
Up0122 201
Vancouver, Canada
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7
Up0122 301
Freiburg im Breisgau, Germany
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8
Up0122 303
Herne, Germany
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9
Up0122 501
Barcelona, Spain
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10
Up0122 502
Barcelona, Spain
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11
Up0122 602
Lausanne, Switzerland
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12
Up0122 601
Sankt Gallen, Switzerland
Actively Recruiting
Research Team
U
UCB Cares
U
UCB Cares
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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