Status:
RECRUITING
A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Moderate to Severe Plaque Psoriasis
Psoriatic Arthritis
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 3 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06888193
Start Date
November 5 2025
End Date
May 3 2027
Last Update
December 26 2025
Active Locations (8)
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1
Up0122 105
Santa Monica, California, United States, 90404
2
Up0122 103
South Miami, Florida, United States, 33143
3
Up0122 102
Durham, North Carolina, United States, 27710
4
Up0122 202
Calgary, Canada