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Bimekizumab in Palmoplantar Pustulosis
NCT07219420Phase 3
Key facts
- Status
- Recruiting
- Start
- Nov 2025
- Primary completion
- Dec 2027
- Countries
- 13
- Sponsor
- UCB
- Modality
- Recombinant Proteins and Enzymes, Monoclonal Antibodies
- Drugs
- bimekizumab
- Conditions
- palmoplantar pustulosis (PPP)
01
Overview
Phase 3, randomised, double-blind trial in palmoplantar pustulosis (PPP) comparing Bimekizumab with Placebo (2 arms). Primary endpoint: Palmoplantar Pustulosis-Investigator Global Assessment 0/1 at 16 weeks. Started Nov 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Bimekizumab
Subjects receive bimekizumab dosing regimen for the entire duration of the study.
Placebo
Subjects receive placebo during the initial treatment period before transitioning to bimekizumab in the maintenance treatment period.
03
Who it enrols
Adults with a diagnosis of palmoplantar pustulosis for at least 24 weeks, exhibiting moderate to severe symptoms (PPPASI >=12, PPP-IGA >=3, >5 active pustules), who are candidates for systemic therapy or phototherapy. Excludes patients with significant symptom improvement prior to baseline, other forms of psoriasis or eczema, drug-induced psoriasis, or prior use of IL-17 inhibitors.
04
Endpoints
Primary
Palmoplantar Pustulosis-Investigator Global Assessment 0/1
Secondary
Palmoplantar Pustulosis Area Severity Index 50
Palmoplantar Pustulosis Area Severity Index 75
Palmoplantar Pustulosis Area Severity Index 90
Palmoplantar Pustulosis-Investigator Global Assessment 0/1
Dermatology Life Quality Index
Numerical Rating Scale - Palmoplantar Pustulosis Pain
Treatment-Emergent Adverse Events
Serious Treatment-Emergent Adverse Events
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