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

Recruiting now · Phase 1

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

In brief

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

Key facts

Study ID

NCT06888193

Run by

UCB Biopharma SRL

People needed

20

Starts

2025-11-05

Expected to finish

2027-05-03

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Up0122 105 — Santa Monica, California, United States (enrolling)
• Up0122 103 — South Miami, Florida, United States (enrolling)
• Up0122 104 — Boston, Massachusetts, United States (enrolling)
• Up0122 106 — Chapel Hill, North Carolina, United States (enrolling)
• Up0122 102 — Durham, North Carolina, United States (enrolling)
• Up0122 101 — Milwaukee, Wisconsin, United States (enrolling)
• Up0122 202 — Calgary, Canada (enrolling)
• Up0122 201 — Vancouver, Canada (enrolling)
• Up0122 301 — Freiburg im Breisgau, Germany (enrolling)
• Up0122 303 — Herne, Germany (enrolling)
• Up0122 501 — Barcelona, Spain (enrolling)
• Up0122 502 — Barcelona, Spain (enrolling)
• Up0122 602 — Lausanne, Switzerland (enrolling)
• Up0122 601 — Sankt Gallen, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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