RECRUITINGPhase 1INTERVENTIONAL
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)
About This Trial
Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.
Who May Be Eligible (Plain English)
Who May Qualify:
- Study participant must be at least 18 years of age at the time of signing the willing to sign a consent form.
- 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.
Who Should NOT Join This Trial:
- 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).
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Bimekizumab
Bimekizumab under the care of their treating physician.
Locations (11)
Up0122 105
Santa Monica, California, United States
Up0122 103
South Miami, Florida, United States
Up0122 102
Durham, North Carolina, United States
Up0122 101
Milwaukee, Wisconsin, United States
Up0122 202
Calgary, Canada
Up0122 201
Vancouver, Canada
Up0122 303
Herne, Germany
Up0122 501
Barcelona, Spain
Up0122 502
Barcelona, Spain
Up0122 602
Lausanne, Switzerland
Up0122 601
Sankt Gallen, Switzerland