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Palmoplantar PustulosisPhase 3BeSeenNCT07219420

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

A Phase 3 study testing Bimekizumab in people with Palmoplantar Pustulosis, run by UCB Biopharma SRL at 91 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Palmoplantar Pustulosis
What is being tested?
Bimekizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
320 participants
Where
91 sitesin 13 countries
Study dates
14 Nov 2025to 22 Nov 2029
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

91 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

91 sites in 13 countries

China15 sites, 15 recruiting
  • Ppp001 20357

    Beijing

    Recruiting
  • Ppp001 20137

    Chengdu

    Recruiting
  • Ppp001 20352

    Chengdu

    Recruiting
  • Ppp001 20350

    Chongqing

    Recruiting
  • Ppp001 20311

    Guangzhou

    Recruiting
  • Ppp001 20313

    Guangzhou

    Recruiting
  • Ppp001 20022

    Hangzhou

    Recruiting
  • Ppp001 20193

    Hangzhou

    Recruiting
  • Ppp001 20344

    Jinan

    Recruiting
  • Ppp001 20355

    Jinan

    Recruiting
  • Ppp001 20345

    Shanghai

    Recruiting
  • Ppp001 20184

    Shenzhen

    Recruiting
  • Ppp001 20136

    Tianjin

    Recruiting
  • Ppp001 20356

    Xi'an

    Recruiting
  • Ppp001 20353

    Yinchuan

    Recruiting

Other trials in China

Poland13 sites, 13 recruiting
  • Ppp001 40626

    Bialystok

    Recruiting
  • Ppp001 40637

    Gdansk

    Recruiting
  • Ppp001 40878

    Katowice

    Recruiting
  • Ppp001 40915

    Krakow

    Recruiting
  • Ppp001 40625

    Lodz

    Recruiting
  • Ppp001 40757

    Poznan

    Recruiting
  • Ppp001 40396

    Rzeszów

    Recruiting
  • Ppp001 40743

    Szczecin

    Recruiting
  • Ppp001 40788

    Torun

    Recruiting
  • Ppp001 40604

    Warsaw

    Recruiting
  • Ppp001 40876

    Warsaw

    Recruiting
  • Ppp001 40334

    Wroclaw

    Recruiting
  • Ppp001 40862

    Wroclaw

    Recruiting

Other trials in Poland

Germany12 sites, 12 recruiting
  • Ppp001 40875

    Ahaus

    Recruiting
  • Ppp001 40740

    Bad Bentheim

    Recruiting
  • Ppp001 40515

    Berlin

    Recruiting
  • Ppp001 40891

    Bielefeld

    Recruiting
  • Ppp001 40893

    Bochum

    Recruiting
  • Ppp001 40356

    Dresden

    Recruiting
  • Ppp001 40866

    Göttingen

    Recruiting
  • Ppp001 40249

    Kiel

    Recruiting
  • Ppp001 40892

    Lübeck

    Recruiting
  • Ppp001 40747

    Mainz

    Recruiting
  • Ppp001 40177

    Münster

    Recruiting
  • Ppp001 40366

    Rostock

    Recruiting

Other trials in Germany

South Korea12 sites, 12 recruiting
  • Ppp001 20366

    Anyang-si

    Recruiting
  • Ppp001 20211

    Bucheon-si

    Recruiting
  • Ppp001 20214

    Busan

    Recruiting
  • Ppp001 20215

    Gwangju

    Recruiting
  • Ppp001 20367

    Jeonju

    Recruiting
  • Ppp001 20208

    Seongnam-si

    Recruiting
  • Ppp001 20104

    Seoul

    Recruiting
  • Ppp001 20216

    Seoul

    Recruiting
  • Ppp001 20220

    Seoul

    Recruiting
  • Ppp001 20351

    Seoul

    Recruiting
  • Ppp001 20354

    Seoul

    Recruiting
  • Ppp001 20359

    Seoul

    Recruiting

Other trials in South Korea

Spain9 sites, 9 recruiting
  • Ppp001 40750

    Alicante

    Recruiting
  • Ppp001 40266

    Badalona

    Recruiting
  • Ppp001 40885

    Granada

    Recruiting
  • Ppp001 40888

    Madrid

    Recruiting
  • Ppp001 40889

    Málaga

    Recruiting
  • Ppp001 40297

    Manises

    Recruiting
  • Ppp001 40879

    Santiago de Compostela

    Recruiting
  • Ppp001 40230

    Valencia

    Recruiting
  • Ppp001 40868

    Valencia

    Recruiting

Other trials in Spain

United States8 sites, 8 recruiting
  • Ppp001 50757

    Auburn Hills, Michigan, 48326

    Recruiting
  • Ppp001 50754

    Birmingham, Alabama, 35205

    Recruiting
  • Ppp001 50745

    Columbus, Ohio, 43213

    Recruiting
  • Ppp001 50202

    Fairborn, Ohio, 45324

    Recruiting
  • Ppp001 50176

    Fremont, California, 94538

    Recruiting
  • Ppp001 50733

    Mayfield Heights, Ohio, 44124

    Recruiting
  • Ppp001 50746

    Miami, Florida, 33126

    Recruiting
  • Ppp001 50744

    Oklahoma City, Oklahoma, 73170

    Recruiting

Other trials in United States

Canada7 sites, 7 recruiting
  • Ppp001 50233

    Barrie

    Recruiting
  • Ppp001 50354

    Calgary

    Recruiting
  • Ppp001 50749

    Fredericton

    Recruiting
  • Ppp001 50765

    London

    Recruiting
  • Ppp001 50740

    Québec

    Recruiting
  • Ppp001 50752

    Red Deer

    Recruiting
  • Ppp001 50750

    Surrey

    Recruiting

Other trials in Canada

France3 sites, 3 recruiting
  • Ppp001 40067

    Lyon

    Recruiting
  • Ppp001 40874

    Nice

    Recruiting
  • Ppp001 40887

    Toulon

    Recruiting

Other trials in France

Hungary3 sites, 3 recruiting
  • Ppp001 40203

    Budapest

    Recruiting
  • Ppp001 40895

    Debrecen

    Recruiting
  • Ppp001 40894

    Orosháza

    Recruiting

Other trials in Hungary

Italy3 sites, 3 recruiting
  • Ppp001 40816

    Brescia

    Recruiting
  • Ppp001 40567

    Roma

    Recruiting
  • Ppp001 40830

    Rozzano

    Recruiting

Other trials in Italy

United Kingdom3 sites, 3 recruiting
  • Ppp001 40113

    London

    Recruiting
  • Ppp001 40880

    London

    Recruiting
  • Ppp001 40108

    Salford

    Recruiting

Other trials in United Kingdom

Czechia2 sites, 2 recruiting
  • Ppp001 40748

    Plzen-bory

    Recruiting
  • Ppp001 40881

    Ústí nad Labem

    Recruiting

Other trials in Czechia

Denmark1 site, 1 recruiting
  • Ppp001 40886

    Hellerup

    Recruiting

Other trials in Denmark

About this study

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

The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP).

Being tested
Bimekizumab, Placebo
Keywords
Bimekizumab, PPP
Medical subject headings
Psoriasis, Aggressive Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BimekizumabDrug

    Also called BIMZELX, UCB4940

    Study participants will receive bimekizumab at pre-specified time points.

  • PlaceboDrug

    Also called PLB

    Study participants will receive matching placebo at pre-specified time points.

Study groups in NCT07219420
Study groupRoleWhat they receive
BimekizumabExperimentalSubjects randomized to this arm will receive the bimekizumab dosing regimen for the entire duration of the study.
Receives: Drug: Bimekizumab
PlaceboPlacebo comparatorSubjects randomized to this arm will receive placebo during the initial treatment period before transitioning to bimekizumab in the maintenance treatment period.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Palmoplantar pustulosis-Investigator Global Assessment 0/1 (PPP-IGA 0/1) response at Week 16

    PPP-IGA is an overall assessment by a physician regarding condition of skin lesions on the palms and the soles in PPP. The Investigator will assess the overall severity of PPP using the following 5-point scale: 0 = Clear; 1 = Almost clear; 2 = Mild ; 3 = Moderate; 4 = Severe.

    Measured: At Week 16

Secondary outcomes (10)
  1. Palmoplantar Pustulosis Area Severity Index 50 (PPPASI50) response at Week 16

    The PPPASI50 response is based on at least 50% improvement from baseline in the PPPASI total score which assesses the severity of PPP skin lesions.

    The PPPASI evaluates 4 areas: right palm, left palm, right sole, and left sole which account for 20%, 20%, 30%, and 30%, respectively, of the total surface area of the palms or soles. Each palm and sole is evaluated for 3 characteristics: erythema, pustule, and desquamation. Each characteristic is rated on a 5-point severity scale, from 0 (none) to 4 (very severe). The percentage of area affected by PPP skin lesions is also evaluated for each palm and sole. The PPPASI total score ranges from 0 to 72, with a higher score indicating higher disease severity.

    Measured: At Week 16

  2. PPPASI75 response at Week 16

    The PPPASI75 response is based on at least 75% improvement from baseline in the PPPASI score.

    Measured: At Week 16

  3. PPPASI90 response at Week 16

    The PPPASI90 response is based on at least 90% improvement from baseline in the PPPASI score.

    Measured: At Week 16

  4. PPPASI50 response at Week 8

    The PPPASI50 response is based on at least 50% improvement from baseline in the PPPASI score.

    Measured: At Week 8

  5. PPP-IGA 0/1 response at Week 8

    PPP-IGA is an overall assessment by a physician regarding condition of skin lesions on the palms and the soles in PPP.

    Measured: At Week 8

  6. Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16

    The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect participants' health-related quality of life (HRQOL). This questionnaire asks participants 10 questions about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. For each question, participants are asked to evaluate on a 4-point scale (from 0=Not at all to 3=Very much) to which extend their skin disease has affected their life over the last week. The DLQI total score ranges from 0 to 30 with higher scores indicating lower HRQOL.

    Measured: From Baseline to Week 16

  7. Change from Baseline in Numerical Rating Scale (NRS) - PPP Pain score in the palmoplantar areas at Week 16

    The study participant will score the worst level of PPP skin pain over the past 24 hours on a 11-point NRS from "0=no skin pain" to "10=very severe skin pain.

    Measured: From Baseline to Week 16

  8. Incidence of treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-up (SFU) Period

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP to the end of the SFU Period.

    Measured: From Baseline (Day 1) until Safety Follow-Up (up to Week 117)

  9. Incidence of serious TEAEs from Baseline to the end of the SFU Period

    An SAE is any untoward medical occurrence that at any dose:

    • Results in death
    • Is life-threatening
    • Requires inpatient hospitalization or prolongation of existing hospitalization
    • Results in persistent or significant disability/incapacity
    • Is a congenital anomaly/birth defect
    • Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP to the end of the SFU Period.

    Measured: From Baseline (Day 1) until Safety Follow-Up (up to Week 117)

  10. Incidence of TEAEs leading to permanent discontinuation of study treatment from Baseline to the end of the SFU Period

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP to the end of the SFU Period.

    This measure considers any TEAE leading to permanent discontinuation of IMP regardless of reason.

    Measured: From Baseline (Day 1) until Safety Follow-Up (up to Week 117)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2025
  2. Study start14 Nov 2025
  3. Primary completion27 Dec 2027 (estimated)
  4. Study completion22 Nov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07219420
Sponsor's protocol ID
PPP001
Other IDs
U1111-1322-7183, 2024-520337-80-00
Acronym
BeSeen
Status last verified
Aug 2026
First submitted
17 Oct 2025
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

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