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.
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
- 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
Poland13 sites, 13 recruiting
- 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
Germany12 sites, 12 recruiting
- 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
South Korea12 sites, 12 recruiting
- 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
Spain9 sites, 9 recruiting
- 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
United States8 sites, 8 recruiting
- 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
Canada7 sites, 7 recruiting
- 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
France3 sites, 3 recruiting
- Recruiting
Ppp001 40067
Lyon
- Recruiting
Ppp001 40874
Nice
- Recruiting
Ppp001 40887
Toulon
Hungary3 sites, 3 recruiting
- Recruiting
Ppp001 40203
Budapest
- Recruiting
Ppp001 40895
Debrecen
- Recruiting
Ppp001 40894
Orosháza
Italy3 sites, 3 recruiting
- Recruiting
Ppp001 40816
Brescia
- Recruiting
Ppp001 40567
Roma
- Recruiting
Ppp001 40830
Rozzano
United Kingdom3 sites, 3 recruiting
- Recruiting
Ppp001 40113
London
- Recruiting
Ppp001 40880
London
- Recruiting
Ppp001 40108
Salford
Czechia2 sites, 2 recruiting
- Recruiting
Ppp001 40748
Plzen-bory
- Recruiting
Ppp001 40881
Ústí nad Labem
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).
- Conditions
- Palmoplantar Pustulosis
- 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 group | Role | What they receive |
|---|---|---|
| Bimekizumab | Experimental | Subjects randomized to this arm will receive the bimekizumab dosing regimen for the entire duration of the study. Receives: Drug: Bimekizumab |
| Placebo | Placebo comparator | Subjects 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.
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)
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
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
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
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
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
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
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
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)
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)
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.
- First posted21 Oct 2025
- Study start14 Nov 2025
- Primary completion27 Dec 2027 (estimated)
- Study completion22 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palmoplantar PustulosisStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 22733 (UCB)
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.