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

UCB

Status and phase: Not yet enrolling; Phase 1

Conditions: Moderate to Severe Plaque Psoriasis; Axial Spondyloarthritis; Psoriatic Arthritis; Hidradenitis Suppurativa

Treatments: Drug: Bimekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06888193

U1111-1318-5063 (Other Identifier)

UP0122

2024-518689-29 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Bimekizumab

Experimental group

Description:

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.

Treatment:

Drug: Bimekizumab