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NCT07219420PHASE3Recruiting

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

UCB Biopharma SRL

Start Date

11/14/2025

Completion Date

11/22/2029

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

Age Range: 18 years to No maximum

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

Interventions

DRUG

Bimekizumab

DRUG

Placebo

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Conditions

Palmoplantar Pustulosis

Locations

Ppp001 50754

Birmingham, Alabama 35205

United States

Ppp001 50746

Coral Gables, Florida 33134

United States

Ppp001 50757

Auburn Hills, Michigan 48326

United States

Ppp001 50745

Columbus, Ohio 43213

United States

Ppp001 50202

Fairborn, Ohio 45324

United States

Ppp001 50744

Oklahoma City, Oklahoma 73170

United States

Ppp001 50233

Barrie,

Canada

Ppp001 50354

Calgary,

Canada

Ppp001 50749

Fredericton,

Canada

Ppp001 50765

London,

Canada

Ppp001 50740

Québec,

Canada

Ppp001 50752

Red Deer,

Canada

Ppp001 50750

Surrey,

Canada

Ppp001 20357

Beijing,

China

Ppp001 20137

Chengdu,

China

Ppp001 20352

Chengdu,

China

Ppp001 20350

Chongqing,

China

Ppp001 20311

Guangzhou,

China

Ppp001 20313

Guangzhou,

China

Ppp001 20022

Hangzhou,

China

Ppp001 20193

Hangzhou,

China

Ppp001 20344

Jinan,

China

Ppp001 20355

Jinan,

China

Ppp001 20345

Shanghai,

China

Ppp001 20184

Shenzhen,

China

Ppp001 20136

Tianjin,

China

Ppp001 20356

Xi'an,

China

Ppp001 20353

Yinchuan,

China

Ppp001 40881

Ústí nad Labem,

Czechia

Ppp001 40886

Hellerup,

Denmark

Ppp001 40067

Lyon,

France

Ppp001 40874

Nice,

France

Ppp001 40887

Toulon,

France

Ppp001 40875

Ahaus,

Germany

Ppp001 40740

Bad Bentheim,

Germany

Ppp001 40515

Berlin,

Germany

Ppp001 40891

Bielefeld,

Germany

Ppp001 40893

Bochum,

Germany

Ppp001 40356

Dresden,

Germany

Ppp001 40866

Göttingen,

Germany

Ppp001 40249

Kiel,

Germany

Ppp001 40892

Lübeck,

Germany

Ppp001 40747

Mainz,

Germany

Ppp001 40177

Münster,

Germany

Ppp001 40366

Rostock,

Germany

Ppp001 40203

Budapest,

Hungary

Ppp001 40895

Debrecen,

Hungary

Ppp001 40894

Orosháza,

Hungary

Ppp001 40816

Brescia,

Italy

Ppp001 40567

Roma,

Italy

Ppp001 40830

Rozzano,

Italy

Ppp001 40626

Bialystok,

Poland

Ppp001 40637

Gdansk,

Poland

Ppp001 40878

Katowice,

Poland

Ppp001 40915

Krakow,

Poland

Ppp001 40625

Lodz,

Poland

Ppp001 40757

Poznan,

Poland

Ppp001 40396

Rzeszów,

Poland

Ppp001 40743

Szczecin,

Poland

Ppp001 40788

Torun,

Poland

Ppp001 40604

Warsaw,

Poland

Ppp001 40876

Warsaw,

Poland

Ppp001 40334

Wroclaw,

Poland

Ppp001 40862

Wroclaw,

Poland

Ppp001 20366

Anyang-si,

South Korea

Ppp001 20211

Bucheon-si,

South Korea

Ppp001 20214

Busan,

South Korea

Ppp001 20215

Gwangju,

South Korea

Ppp001 20367

Jeonju,

South Korea

Ppp001 20208

Seongnam-si,

South Korea

Ppp001 20104

Seoul,

South Korea

Ppp001 20216

Seoul,

South Korea

Ppp001 20220

Seoul,

South Korea

Ppp001 20351

Seoul,

South Korea

Ppp001 20354

Seoul,

South Korea

Ppp001 40750

Alicante,

Spain

Ppp001 40266

Badalona,

Spain

Ppp001 40885

Granada,

Spain

Ppp001 40888

Madrid,

Spain

Ppp001 40297

Manises,

Spain

Ppp001 40889

Málaga,

Spain

Ppp001 40879

Santiago de Compostela,

Spain

Ppp001 40230

Valencia,

Spain

Ppp001 40868

Valencia,

Spain

Ppp001 40113

London,

United Kingdom

Ppp001 40880

London,

United Kingdom

Ppp001 40108

Salford,

United Kingdom