BridgeMD
A study to learn how safe bimekizumab is and how well it works in adults with palmoplantar pustulosis
EU CTIS ID: 2024-520337-80-00
What this study is testing
To evaluate the efficacy of bimekizumab compared with placebo in participants with PPP at Week 16.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant must be at least 18 years of age inclusive, at the time of signing the informed consent form (ICF).
- Participant must have a palmoplantar pustulosis (PPP) diagnosis for at least 24 weeks prior to the Screening Visit.
- Participant must have Palmoplantar Pustulosis Area Severity Index (PPPASI) ≥12 at the Screening Visit and Baseline Visit.
- Participant must have palmoplantar pustulosis- Investigator Global Assessment (PPP-IGA) ≥3 at the Screening Visit and Baseline Visit.
- Participant must have pustules on the palms of the hands and/or soles of the feet (at the Screening Visit and Baseline Visit), defined as pustule severity ≥2 in at least 1 region and having more than 5 active white- yellow pustules across all regions.
- Participant must be a candidate for systemic therapy or phototherapy.
You likely can't join if
- Participant has PPP symptoms which improve significantly between the Screening Visit and Baseline Visit, defined as a reduction in the PPPASI score.
- Participant has palmoplantar PSO (plaque PSO on palms/soles).
- Participant has the following: guttate PSO, erythrodermic PSO (EP), generalized pustular PSO (GPP), Acrodermatitis continua of Hallopeau (ACH), atopic dermatitis, dyshidrotic eczema, chronic hand eczema, or folliculitis.
- Participant has drug-induced PSO (eg, first onset or current exacerbation due to beta blockers, calcium channel inhibitors, lithium, or TNF inhibitor) or drug-induced pustular PSO (eg, acute generalized exanthematous pustulosis, acute localized exanthematous pustulosis).
- Participant has cutaneous lesions that may interfere with the evaluation of the affected area and/or evaluation of the severity of PPP.
- Participant is taking or has taken prohibited or restricted medications without meeting the mandatory discontinuation or stability period relative to the Baseline Visit.
See the full eligibility criteria
- Participant must be at least 18 years of age inclusive, at the time of signing the informed consent form (ICF).
- Participant must have a palmoplantar pustulosis (PPP) diagnosis for at least 24 weeks prior to the Screening Visit.
- Participant must have Palmoplantar Pustulosis Area Severity Index (PPPASI) ≥12 at the Screening Visit and Baseline Visit.
- Participant must have palmoplantar pustulosis- Investigator Global Assessment (PPP-IGA) ≥3 at the Screening Visit and Baseline Visit.
- Participant must have pustules on the palms of the hands and/or soles of the feet (at the Screening Visit and Baseline Visit), defined as pustule severity ≥2 in at least 1 region and having more than 5 active white- yellow pustules across all regions.
- Participant must be a candidate for systemic therapy or phototherapy.
- Participant has PPP symptoms which improve significantly between the Screening Visit and Baseline Visit, defined as a reduction in the PPPASI score.
- Participant has palmoplantar PSO (plaque PSO on palms/soles).
- Participant has the following: guttate PSO, erythrodermic PSO (EP), generalized pustular PSO (GPP), Acrodermatitis continua of Hallopeau (ACH), atopic dermatitis, dyshidrotic eczema, chronic hand eczema, or folliculitis.
- Participant has drug-induced PSO (eg, first onset or current exacerbation due to beta blockers, calcium channel inhibitors, lithium, or TNF inhibitor) or drug-induced pustular PSO (eg, acute generalized exanthematous pustulosis, acute localized exanthematous pustulosis).
- Participant has cutaneous lesions that may interfere with the evaluation of the affected area and/or evaluation of the severity of PPP.
- Participant is taking or has taken prohibited or restricted medications without meeting the mandatory discontinuation or stability period relative to the Baseline Visit.
- Participant is taking or has ever taken an IL-17A/IL-17F inhibitor, including bimekizumab, or has participated in a bimekizumab investigational study.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- United Kingdom
- China
- Canada
- United States
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 all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; United Kingdom; China; Canada; United States. 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 EU CTIS; the study team decides eligibility.