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

Last updated: August 19, 2025
Sponsor: UCB Biopharma SRL
Overall Status: Active - Recruiting

Phase

1

Condition

Psoriatic Arthritis

Psoriasis And Psoriatic Disorders

Arthritis And Arthritic Pain

Treatment

Bimekizumab

Clinical Study ID

NCT06888193
UP0122
U1111-1318-5063
2024-518689-29
  • Ages > 18
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Study participant must be at least 18 years of age at the time of signing theinformed consent.

  • Study participant is being treated with commercial bimekizumab per locally approvedprescribing information and in accordance with her treating physician.

  • Study participant is breastfeeding and intends to breastfeed throughout the SamplingPeriod.

  • The decision to treat with bimekizumab and to breastfeed is made independently fromand prior to the study participant consenting to participate in the study.

  • Study participant must be on bimekizumab treatment for at least 12 weeks afterdelivery 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 anddoes not plan to become pregnant during the study.

Exclusion

Exclusion Criteria:

  • Study participant has any medical, obstetrical, or psychiatric condition that, inthe opinion of the Investigator, could jeopardize or would compromise the studyparticipant's ability to participate in this study.

  • The infant has any abnormality noted on physical examination or medical historythat, in the opinion of the Investigator, may jeopardize or compromise studyparticipation.

  • Study participant has a history of chronic alcohol or drug abuse within the previouslast year.

  • Study participant has history of breast implants, breast augmentation, or breastreduction surgery.

  • Study participant plans a surgical intervention during the Screening Period andSampling Period or anticipates having surgery while participating in the SamplingPeriod (does not apply to tubal ligation).

  • Study participant or her infant has participated in another study of aninvestigational medicinal product (IMP) (and/or an investigational device) withinthe 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 bimekizumabregistry study.

  • Study participant or her infant has previously participated (ie, entered thesampling period) in this study.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Bimekizumab
Phase: 1
Study Start date:
August 01, 2025
Estimated Completion Date:
May 03, 2027

Connect with a study center

  • Up0122 202

    Calgary,
    Canada

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.