Assessing Bimekizumab Levels in Breast Milk of Nursing Mothers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the concentration of bimekizumab, a treatment for various inflammatory conditions, in the breast milk of mothers who are receiving this medication. Participants must be breastfeeding and have been on bimekizumab treatment for at least 12 weeks post-delivery. The study aims to ensure that the medication is safe for nursing infants by measuring its levels in mature breast milk. The findings could provide important insights into the implications of bimekizumab use during breastfeeding.

Why it matters

Who can join: the full rules

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.

Where it's running

• Up0122 105
  Santa Monica, California, United States Recruiting
• Up0122 103
  South Miami, Florida, United States Recruiting
• Up0122 104
  Boston, Massachusetts, United States Recruiting
• Up0122 106
  Chapel Hill, North Carolina, United States Recruiting
• Up0122 102
  Durham, North Carolina, United States Recruiting
• Up0122 101
  Milwaukee, Wisconsin, United States Recruiting

Study contacts

• Study coordinator: UCB Cares
• Email: ucbcares@ucb.com
• Phone: 1-844-599-2273 (USA)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.