No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 1
Study type
Interventional
Purpose
Other
Participants needed
20 (estimated)
Sponsor
UCB Biopharma SRL · Industry
Who this trial is looking for
This trial is looking for mothers who are breastfeeding and are being treated with bimekizumab. Participants will provide breast milk samples to assess the concentration of the treatment in the milk.
Are You a Good Fit for This Trial?
Must be takingBimekizumab
You may be able to join if
I am at least 18 years old.
I am being treated with bimekizumab as prescribed by my doctor.
I am breastfeeding and plan to continue throughout the study.
I started bimekizumab treatment at least 12 weeks after giving birth.
I am not pregnant and do not plan to become pregnant during the study.
You may not be able to join if
I have a medical, mental, or pregnancy-related condition that may affect my participation.
My infant has any health issues that may affect participation.
I have a history of drug or alcohol abuse in the past year.
I have had surgery on my breasts.
I plan to have surgery during the study.
I or my infant have participated in another study involving investigational products in the last 6 months.
I or my infant have previously taken part in this study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 b…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.