A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis
BeSeen
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
3 other identifiers
interventional
300
9 countries
41
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2025
Typical duration for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2025
CompletedFirst Posted
Study publicly available on registry
October 21, 2025
CompletedStudy Start
First participant enrolled
November 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 22, 2029
April 13, 2026
April 1, 2026
2.1 years
October 17, 2025
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
At Week 16
Secondary Outcomes (10)
Palmoplantar Pustulosis Area Severity Index 50 (PPPASI50) response at Week 16
At Week 16
PPPASI75 response at Week 16
At Week 16
PPPASI90 response at Week 16
At Week 16
PPPASI50 response at Week 8
At Week 8
PPP-IGA 0/1 response at Week 8
At Week 8
- +5 more secondary outcomes
Study Arms (2)
Bimekizumab
EXPERIMENTALSubjects randomized to this arm will receive the bimekizumab dosing regimen for the entire duration of the study.
Placebo
PLACEBO COMPARATORSubjects randomized to this arm will receive placebo during the initial treatment period before transitioning to bimekizumab in the maintenance treatment period.
Interventions
Study participants will receive bimekizumab at pre-specified time points.
Study participants will receive matching placebo at pre-specified time points.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Ppp001 50233
Barrie, 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 20313
Guangzhou, China
Ppp001 20022
Hangzhou, China
Ppp001 20355
Jinan, China
Ppp001 20345
Shanghai, China
Ppp001 20184
Shenzhen, China
Ppp001 20136
Tianjin, China
Ppp001 20356
Xi'an, China
Ppp001 40886
Hellerup, Denmark
Ppp001 40875
Ahaus, Germany
Ppp001 40740
Bad Bentheim, Germany
Ppp001 40893
Bochum, Germany
Ppp001 40356
Dresden, Germany
Ppp001 40866
Göttingen, Germany
Ppp001 40249
Kiel, Germany
Ppp001 40895
Debrecen, Hungary
Ppp001 40894
Orosháza, Hungary
Ppp001 40816
Brescia, Italy
Ppp001 40567
Roma, Italy
Ppp001 40637
Gdansk, Poland
Ppp001 40915
Krakow, Poland
Ppp001 40757
Poznan, Poland
Ppp001 40396
Rzeszów, Poland
Ppp001 40743
Szczecin, Poland
Ppp001 40604
Warsaw, Poland
Ppp001 40625
Warsaw, Poland
Ppp001 40862
Wroclaw, Poland
Ppp001 40750
Alicante, Spain
Ppp001 40888
Madrid, Spain
Ppp001 40297
Manises, Spain
Ppp001 40889
Málaga, Spain
Ppp001 40880
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 22733 (UCB)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2025
First Posted
October 21, 2025
Study Start
November 14, 2025
Primary Completion (Estimated)
December 27, 2027
Study Completion (Estimated)
November 22, 2029
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 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.
- Access Criteria
- Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, 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.
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.