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

NCT ID: NCT06888193
Registry status: Recruiting
Study type: Not specified in the registry data
Phase: Phase 1
Sponsor: UCB Biopharma SRL

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 20 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages: Not specified in the registry data
Sex: Not specified in the registry data
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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.

Study locations

14 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Canada, Germany, Spain, Switzerland, United States

California, United States: 1
Florida, United States: 1
Massachusetts, United States: 1
North Carolina, United States: 2
Wisconsin, United States: 1

Sample of listed locations

Up0122 202 — Calgary, Canada — Site recruitment status not specified in the registry data
Up0122 201 — Vancouver, Canada — Site recruitment status not specified in the registry data
Up0122 301 — Freiburg im Breisgau, Germany — Site recruitment status not specified in the registry data
Up0122 303 — Herne, Germany — Site recruitment status not specified in the registry data
Up0122 501 — Barcelona, Spain — Site recruitment status not specified in the registry data
Up0122 502 — Barcelona, Spain — Site recruitment status not specified in the registry data
Up0122 602 — Lausanne, Switzerland — Site recruitment status not specified in the registry data
Up0122 601 — Sankt Gallen, Switzerland — Site recruitment status not specified in the registry data
Up0122 105 — Santa Monica, California, 90404, United States — Site recruitment status not specified in the registry data
Up0122 103 — South Miami, Florida, 33155, United States — Site recruitment status not specified in the registry data
Up0122 104 — Boston, Massachusetts, 02215, United States — Site recruitment status not specified in the registry data
Up0122 106 — Chapel Hill, North Carolina, 27516, United States — Site recruitment status not specified in the registry data
Up0122 102 — Durham, North Carolina, 27710, United States — Site recruitment status not specified in the registry data
Up0122 101 — Milwaukee, Wisconsin, 53226, United States — Site recruitment status not specified in the registry data

Study details

Start date: November 5, 2025
Primary completion date: December 31, 2027
First posted: March 21, 2025

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06888193
Registry last updated: September 18, 2026
QualifiedStudies registry data refreshed: September 21, 2026

View NCT06888193 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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