Measures bimekizumab levels in breast milk of mothers taking it
Tests how much bimekizumab passes into breast milk in women treated for psoriasis or arthritis.
Plain-language title generated from the registry record
Registry title: A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
Key facts
- Where
- Calgary and Vancouver, CanadaSee the 2 sites
- Phase
- Phase 1
Where in Canada
- Up0122 202Calgary, CanadaTaking people
- Up0122 201Vancouver, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UCB Biopharma SRL
- Trial code
- NCT06888193EU 2024-518689-29-00
- Record updated
- 18 September 2026
- Original description
Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.Read full original descriptionShow less
A Multicenter Open-label, Prospective Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.
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 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; 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; 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.