Bimekizumab in adult Participants with Palmoplantar Pustulosis-PPP001
Research type
Research Study
Full title
A Phase 3, randomized, double-blind, placebo-controlled, multicenter study with Open-label Extension to evaluate the efficacy and safety of bimekizumab in study participants with palmoplantar pustulosis
IRAS ID
1012696
Contact name
Luk Vandebriel
Contact email
Sponsor organisation
UCB Biopharma SRL
Research summary
Palmoplantar pustulosis (PPP) is a chronic skin condition that causes small, pus-filled blisters (pustules) to develop primarily on the palms of the hands and/or the soles of the feet. These bumps eventually dry out, turn brown, and peel off. The affected skin often becomes red, thick, and scaly between outbreaks. It's considered an autoimmune condition, where the body's immune system mistakenly attacks healthy skin cells.
There's no permanent cure for PPP; various treatments can help manage symptoms, including topical medications, light therapy, systemic medications. The study drug bimekizumab is designed to reduce inflammation from the inside of the body. In this study, the researchers want to learn how safe bimekizumab is, how well patients accommodate with it and how well it works in adults with PPP.
This is a Phase 3, randomised, double-blind, placebo-controlled study. Approximately 300 participants from multiple countries will take part in this global study for up to 2.5 years (30 months).
Randomised means that a computer program will randomly assign the treatment each participant receives. Double-blind means none of the participants, researchers, study doctors, or other study staff will know what treatment each participant receives. Placebo-controlled means that some participants will receive a placebo (something that looks identical but contains no active ingredients).
For the first 16 weeks of treatment, half of the participants will receive bimekizumab once every 4 weeks. The other half of the participants will receive the placebo once every 4 weeks. For the rest of the first year, all participants will receive bimekizumab once every 4 weeks. Then, the participants may choose to continue receiving bimekizumab for another year.
The study medication will be given as an under-the-skin (subcutaneous) injection in the belly area or, upper arm, or outer thigh.
The Sponsor of the study is UCB Biopharma SRL.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
25/SC/0346
Date of REC Opinion
20 Nov 2025
REC opinion
Further Information Favourable Opinion