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New treatment option for Moderate to Severe Plaque Psoriasis
Official title A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
ClinicalTrials.gov ID: NCT06888193
What this study is testing
What is Bimekizumab?
Bimekizumab is an investigational medicine, being studied as a potential treatment for moderate to severe plaque psoriasis.
Also referred to as Bimzelx®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- 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...
- Study participant must be on bimekizumab treatment for at least 12 weeks after delivery and since starting/restarting/continuing bimekizumab prior to...
You likely can't join if
- Study participant has any medical, obstetrical, or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would...
- The infant has any abnormality noted on physical examination or medical history that, in the opinion of the Investigator, may jeopardize or...
- 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...
- Study participant or her infant has participated in another study of an investigational medicinal product (IMP) (and/or an investigational device)...
See the full eligibility 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.
- 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 participant or her infant has previously participated (ie, entered the sampling period) in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Santa Monica, California, United States
- South Miami, Florida, United States
- Boston, Massachusetts, United States
- Chapel Hill, North Carolina, United States
- Durham, North Carolina, United States
- Milwaukee, Wisconsin, United States
- Calgary, Canada
- Vancouver, Canada
- Freiburg im Breisgau, Germany
- Herne, Germany
- Barcelona, Spain
- Lausanne, Switzerland
- Sankt Gallen, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Monica, California, United States; South Miami, Florida, United States; Boston, Massachusetts, United States; Chapel Hill, North Carolina, United States; Durham, North Carolina, United States; Milwaukee, Wisconsin, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.