A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study With Open-Label Extension to Evaluate the Efficacy and Safety of Bimekizumab in Participants With Palmoplantar Pustulosis

What this Trial Is About

Researchers are evaluating the effectiveness and safety of bimekizumab compared to a placebo in adults with palmoplantar pustulosis (PPP), a skin condition characterized by pustules on the palms and soles. This phase 3 study is randomized, double-blind, and placebo-controlled, with an open-label extension to further assess outcomes. The main goal is to see how well bimekizumab improves PPP symptoms and quality of life. Participants are randomly assigned to receive either bimekizumab continuously or placebo initially followed by bimekizumab during the maintenance phase. Treatments are given at specific times throughout the study. The study includes an initial treatment period followed by a maintenance period, allowing researchers to compare responses between the two groups and observe long-term effects. During the trial, participants will undergo regular assessments including the Palmoplantar Pustulosis-Investigator Global Assessment (PPP-IGA) and Palmoplantar Pustulosis Area Severity Index (PPPASI) at weeks 8 and 16. Quality of life and pain will be measured using questionnaires like the Dermatology Life Quality Index and a numerical rating scale for pain. Safety will be monitored from the start until up to week 117, tracking adverse events. The total study duration includes treatment and safety follow-up periods.

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis