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

NCT07219420 · UCB Pharma
In plain English

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Official 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
About this study
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 Criteria: * 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 Criteria: * 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
Study design
Enrollment target: 320 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-11-14
Estimated completion: 2029-11-22
Last updated: 2026-07-17
Interventions
Drug: BimekizumabDrug: Placebo
Primary outcomes
  • Palmoplantar pustulosis-Investigator Global Assessment 0/1 (PPP-IGA 0/1) response at Week 16 (At Week 16)
Sponsor
UCB Biopharma SRL · industry
Contacts & investigators
ContactUCB Cares · contact · ucbcares@ucb.com · +18445992273
InvestigatorUCB Cares · study_director, 001 844 599 22733 (UCB)
All locations (87)
Ppp001 50754Recruiting
Birmingham, Alabama, United States
Ppp001 50746Recruiting
Coral Gables, Florida, United States
Ppp001 50757Recruiting
Auburn Hills, Michigan, United States
Ppp001 50745Recruiting
Columbus, Ohio, United States
Ppp001 50202Recruiting
Fairborn, Ohio, United States
Ppp001 50744Recruiting
Oklahoma City, Oklahoma, United States
Ppp001 50233Recruiting
Barrie, Canada
Ppp001 50354Recruiting
Calgary, Canada
Ppp001 50749Recruiting
Fredericton, Canada
Ppp001 50765Recruiting
London, Canada
Ppp001 50740Recruiting
Québec, Canada
Ppp001 50752Recruiting
Red Deer, Canada
Ppp001 50750Recruiting
Surrey, Canada
Ppp001 20357Recruiting
Beijing, China
Ppp001 20137Recruiting
Chengdu, China
Ppp001 20352Recruiting
Chengdu, China
Ppp001 20350Recruiting
Chongqing, China
Ppp001 20311Recruiting
Guangzhou, China
Ppp001 20313Recruiting
Guangzhou, China
Ppp001 20022Recruiting
Hangzhou, China
Ppp001 20193Recruiting
Hangzhou, China
Ppp001 20344Recruiting
Jinan, China
Ppp001 20355Recruiting
Jinan, China
Ppp001 20345Recruiting
Shanghai, China
Ppp001 20184Recruiting
Shenzhen, China
Ppp001 20136Recruiting
Tianjin, China
Ppp001 20356Recruiting
Xi'an, China
Ppp001 20353Recruiting
Yinchuan, China
Ppp001 40881Recruiting
Ústí nad Labem, Czechia
Ppp001 40886Recruiting
Hellerup, Denmark
Ppp001 40067Recruiting
Lyon, France
Ppp001 40874Recruiting
Nice, France
Ppp001 40887Recruiting
Toulon, France
Ppp001 40875Recruiting
Ahaus, Germany
Ppp001 40740Recruiting
Bad Bentheim, Germany
Ppp001 40515Recruiting
Berlin, Germany
Ppp001 40891Recruiting
Bielefeld, Germany
Ppp001 40893Recruiting
Bochum, Germany
Ppp001 40356Recruiting
Dresden, Germany
Ppp001 40866Recruiting
Göttingen, Germany
Ppp001 40249Recruiting
Kiel, Germany
Ppp001 40892Recruiting
Lübeck, Germany
Ppp001 40747Recruiting
Mainz, Germany
Ppp001 40177Recruiting
Münster, Germany
Ppp001 40366Recruiting
Rostock, Germany
Ppp001 40203Recruiting
Budapest, Hungary
Ppp001 40895Recruiting
Debrecen, Hungary
Ppp001 40894Recruiting
Orosháza, Hungary
Ppp001 40816Recruiting
Brescia, Italy
Ppp001 40567Recruiting
Roma, Italy
Ppp001 40830Recruiting
Rozzano, Italy
Ppp001 40626Recruiting
Bialystok, Poland
Ppp001 40637Recruiting
Gdansk, Poland
Ppp001 40878Recruiting
Katowice, Poland
Ppp001 40915Recruiting
Krakow, Poland
Ppp001 40625Recruiting
Lodz, Poland
Ppp001 40757Recruiting
Poznan, Poland
Ppp001 40396Recruiting
Rzeszów, Poland
Ppp001 40743Recruiting
Szczecin, Poland
Ppp001 40788Recruiting
Torun, Poland
Ppp001 40604Recruiting
Warsaw, Poland
Ppp001 40876Recruiting
Warsaw, Poland
Ppp001 40334Recruiting
Wroclaw, Poland
Ppp001 40862Recruiting
Wroclaw, Poland
Ppp001 20366Recruiting
Anyang-si, South Korea
Ppp001 20211Recruiting
Bucheon-si, South Korea
Ppp001 20214Recruiting
Busan, South Korea
Ppp001 20215Recruiting
Gwangju, South Korea
Ppp001 20367Recruiting
Jeonju, South Korea
Ppp001 20208Recruiting
Seongnam-si, South Korea
Ppp001 20104Recruiting
Seoul, South Korea
Ppp001 20216Recruiting
Seoul, South Korea
Ppp001 20220Recruiting
Seoul, South Korea
Ppp001 20351Recruiting
Seoul, South Korea
Ppp001 20354Recruiting
Seoul, South Korea
Ppp001 40750Recruiting
Alicante, Spain
Ppp001 40266Recruiting
Badalona, Spain
Ppp001 40885Recruiting
Granada, Spain
Ppp001 40888Recruiting
Madrid, Spain
Ppp001 40297Recruiting
Manises, Spain
Ppp001 40889Recruiting
Málaga, Spain
Ppp001 40879Recruiting
Santiago de Compostela, Spain
Ppp001 40230Recruiting
Valencia, Spain
Ppp001 40868Recruiting
Valencia, Spain
Ppp001 40113Recruiting
London, United Kingdom
Ppp001 40880Recruiting
London, United Kingdom
Ppp001 40108Recruiting
Salford, United Kingdom
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis · TrialPath