Clinical trial NCT06888193: A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
Official title: A Multicenter Open-label, Prospective Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Moderate to Severe Plaque Psoriasis
Psoriatic Arthritis
Axial Spondyloarthritis
Hidradenitis Suppurativa
Keywords: Bimekizumab
Breastfeeding mothers
Bimzelx®
PSO
HS
AxSpa
PsA
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2025-03-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.


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.

Primary outcomes:
measure: Concentration of bimekizumab in the breast milk on Day 1
timeFrame: Day 1
measure: Concentration of bimekizumab in the breast milk on Day 2
timeFrame: Day 2
measure: Concentration of bimekizumab in the breast milk on Day 3
timeFrame: Day 3
measure: Concentration of bimekizumab in the breast milk on Day 5
timeFrame: Day 5
measure: Concentration of bimekizumab in the breast milk on Day 7
timeFrame: Day 7
measure: Concentration of bimekizumab in the breast milk on Day 9
timeFrame: Day 9
measure: Concentration of bimekizumab in the breast milk on Day 11
timeFrame: Day 11
measure: Concentration of bimekizumab in the breast milk on Day 13
timeFrame: Day 13
measure: Concentration of bimekizumab in the breast milk on Day 15
timeFrame: Day 15
measure: Concentration of bimekizumab in the breast milk on Day 29
timeFrame: Day 29
measure: Concentration of bimekizumab in the breast milk on Day 57
timeFrame: Day 57
Secondary outcomes:
measure: Estimated Infant Dosage of bimekizumab from breast milk
timeFrame: Predose on Day 1, 2, 3, 5, 7, 9, 11, 13, 15, 29 and 57
measure: Relative Infant Dose of bimekizumab from breast milk
timeFrame: Predose on Day 1, 2, 3, 5, 7, 9, 11, 13, 15, 29 and 57
measure: Treatment-emergent Adverse Events (TEAEs) of the mother from time of informed consent through SFU contact
timeFrame: From time of informed consent up to approximately 17 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Up0122 202
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: