NCT06888193RecruitingPhase 1
A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
A Multicenter Open-label, Prospective Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 15 Mar 2025
- Start date
- 5 Nov 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- UCB Biopharma SRL
- NCT number
- NCT06888193
- EU CT number
- 2024-518689-29-00
- EudraCT number
- 2024-518689-29
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 5 Nov 2025 to the primary completion date, 31 Dec 2027
- 14 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Study participant has a history of chronic alcohol or drug abuse within the previous last year.
- 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.
Other illness
- 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.
- Study participant has history of breast implants, breast augmentation, or breast reduction surgery.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Up0122 202 Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| Up0122 201 Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| Up0122 602 Coordinator of this site? Confirm its status | Lausanne | Switzerland | Recruiting |
| Up0122 601 Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Recruiting |
| St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Coordinator of this site? Confirm its status | Herne | Germany | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Up0122 104 Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Up0122 106 Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Up0122 102 Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Up0122 101 Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Up0122 105 Coordinator of this site? Confirm its status | Santa Monica | United States | Recruiting |
| Up0122 103 Coordinator of this site? Confirm its status | South Miami | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.