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

Phase 1

Recruiting

• Conditions: Moderate to Severe Plaque Psoriasis; Psoriatic Arthritis; Axial Spondyloarthritis; Hidradenitis Suppurativa
• Interventions: Drug: Bimekizumab

• Registration Number: NCT06888193
• Lead Sponsor: UCB Biopharma SRL

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-15
• Study First Submitted QC: 2025-03-15
• Study First Posted: 2025-03-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Study Start: 2025-05-30
• Primary Completion: 2027-05-03
• Study Completion: 2027-05-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bimekizumab	Bimekizumab	Breastfeeding mothers who are already receiving commercial bimekizumab per locally approved prescribing information and in consultation and agreement with their treating physicians will participate in this study. Study participants will continue receiving commercially available bimekizumab under the care of their treating physician.

Primary Outcome Measures

Name	Time	Method
Concentration of bimekizumab in the breast milk on Day 1	Day 1	Breast milk samples will be collected predose on Day 1.
Concentration of bimekizumab in the breast milk on Day 2	Day 2	Breast milk samples will be collected predose on Day 2.
Concentration of bimekizumab in the breast milk on Day 3	Day 3	Breast milk samples will be collected predose on Day 3.
Concentration of bimekizumab in the breast milk on Day 5	Day 5	Breast milk samples will be collected predose on Day 5.
Concentration of bimekizumab in the breast milk on Day 7	Day 7	Breast milk samples will be collected predose on Day 7.
Concentration of bimekizumab in the breast milk on Day 9	Day 9	Breast milk samples will be collected predose on Day 9.
Concentration of bimekizumab in the breast milk on Day 11	Day 11	Breast milk samples will be collected predose on Day 11.
Concentration of bimekizumab in the breast milk on Day 13	Day 13	Breast milk samples will be collected predose on Day 13.
Concentration of bimekizumab in the breast milk on Day 15	Day 15	Breast milk samples will be collected predose on Day 15.
Concentration of bimekizumab in the breast milk on Day 29	Day 29	Breast milk samples will be collected predose on Day 29 for mothers on every 4 weeks (Q4W) dosing regimen.
Concentration of bimekizumab in the breast milk on Day 57	Day 57	Breast milk samples will be collected predose on Day 57 for mothers on every 8 weeks (Q8W) dosing regimen.

Secondary Outcome Measures

Name	Time	Method
Estimated Infant Dosage of bimekizumab from breast milk	Predose on Day 1, 2, 3, 5, 7, 9, 11, 13, 15, 29 and 57	Breast milk samples will be collected predose on Day 1 (bimekizumab dosing day), Days 2, 3, 5, 7, 9, 11, 13, and 15 for all study participants (Day 15 predose if every 2 weeks (Q2W) dosing regimen), predose on Day 29 (if Q4W dosing regimen) or Day 57 (if Q8W dosing regimen).
Relative Infant Dose of bimekizumab from breast milk	Predose on Day 1, 2, 3, 5, 7, 9, 11, 13, 15, 29 and 57	Breast milk samples will be collected predose on Day 1 (bimekizumab dosing day), Days 2, 3, 5, 7, 9, 11, 13, and 15 for all study participants (Day 15 predose if every 2 weeks (Q2W) dosing regimen), predose on Day 29 (if Q4W dosing regimen) or Day 57 (if Q8W dosing regimen).
Treatment-emergent Adverse Events (TEAEs) of the mother from time of informed consent through SFU contact	From time of informed consent up to approximately 17 weeks	An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.

Trial Locations

Locations (1)

Up0122 202; 🇨🇦 Calgary, Canada