Status:
RECRUITING
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Palmoplantar Pustulosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP).
Eligibility Criteria
Inclusion
- At least 18 years of age inclusive, at the time of signing the informed consent form (ICF)
- Have a palmoplantar pustulosis (PPP) diagnosis for at least 24 weeks prior to the Screening Visit
- Have PPPASI ≥12 at the Screening Visit and Baseline Visit
- Have PPP-IGA ≥3 at the Screening Visit and Baseline Visit
- 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 and having more than 5 active pustules
- Participant must be a candidate for systemic therapy or phototherapy
Exclusion
- Has PPP symptoms which improve significantly between the Screening Visit and Baseline Visit, defined as a reduction in the PPPASI score
- Has the following: palmoplantar PSO (plaque PSO on palms/soles), guttate PSO, erythrodermic PSO (EP), generalized pustular PSO (GPP), Acrodermatitis continua of Hallopeau (ACH), atopic dermatitis, dyshidrotic eczema or chronic hand eczema.
- Has drug-induced PSO (eg, first onset or current exacerbation due to beta blockers, calcium channel inhibitors, lithium, or tumor necrosis factor \[TNF\] inhibitor) or drug-induced pustular PSO (eg, acute generalized exanthematous pustulosis, acute localized exanthematous pustulosis)
- Has cutaneous lesions that may interfere with the evaluation of the affected area and/or evaluation of the severity of PPP
- Is taking or has taken prohibited or restricted medications without meeting the mandatory discontinuation or stability period relative to the Baseline Visit
- Is taking or has ever taken an interleukin (IL)-17A/IL-17F inhibitor, including bimekizumab, or has participated in a bimekizumab investigational study
Key Trial Info
Start Date :
November 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 29 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07219420
Start Date
November 14 2025
End Date
October 29 2029
Last Update
January 8 2026
Active Locations (6)
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1
Ppp001 50740
Québec, Canada
2
Ppp001 20313
Guangzhou, China
3
Ppp001 20022
Hangzhou, China
4
Ppp001 20345
Shanghai, China