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

A Multicenter Open-label, Prospective Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study measures how much bimekizumab (Bimzelx) is in mature breast milk, the milk made after the early milk following birth. It is for breastfeeding mothers age 18 or older who are already taking this medicine.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 when you sign the study consent form.
  • You take bimekizumab as directed by your doctor and under the approved rules where you live.
  • You are breastfeeding and plan to keep breastfeeding while milk samples are collected.
  • You decided to take bimekizumab and breastfeed before agreeing to join the study, separately from that decision.
  • Before milk sampling starts, you have been on bimekizumab for at least 12 weeks after giving birth and at least 12 weeks since starting, restarting, or continuing treatment.
  • You are not pregnant and do not plan to become pregnant during the study.

Who can't join

  • You have a health, childbirth-related, or mental health condition that the study doctor thinks could make taking part unsafe or difficult.
  • Your baby has a finding on a physical exam or in their health history that the study doctor thinks could make taking part unsafe or difficult.
  • You have a history of ongoing alcohol or drug abuse within the past year.
  • You have had breast implants or surgery to make your breasts larger or smaller.
  • You plan or expect to have surgery during screening or milk sampling. Surgery to tie your tubes is allowed.
  • You or your baby joined a study of an experimental medicine or device within the past 6 months, or are in one now. The UCB PS0036 study and bimekizumab registry studies are allowed.
  • You or your baby previously took part in this study and entered the milk sampling period.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (6)

CA

FL

MA

NC

WI