Recruiting NCT07219420
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bimekizumab, Placebo.
- Who it may be relevant to
- Registry conditions: Palmoplantar Pustulosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, China, Czechia, Denmark +8
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP).
Interventions
- Drug Bimekizumab
Study participants will receive bimekizumab at pre-specified time points. - Drug Placebo
Study participants will receive matching placebo at pre-specified time points.
Primary outcome measures
- Palmoplantar pustulosis-Investigator Global Assessment 0/1 (PPP-IGA 0/1) response at Week 16 [Time frame: At Week 16]
Secondary outcome measures (10)
- Palmoplantar Pustulosis Area Severity Index 50 (PPPASI50) response at Week 16 [Time frame: At Week 16]
- PPPASI75 response at Week 16 [Time frame: At Week 16]
- PPPASI90 response at Week 16 [Time frame: At Week 16]
- PPPASI50 response at Week 8 [Time frame: At Week 8]
- PPP-IGA 0/1 response at Week 8 [Time frame: At Week 8]
- Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16 [Time frame: From Baseline to Week 16]
- Change from Baseline in Numerical Rating Scale (NRS) - PPP Pain score in the palmoplantar areas at Week 16 [Time frame: From Baseline to Week 16]
- Incidence of treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-up (SFU) Period [Time frame: 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 [Time frame: 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 [Time frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 117)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 15 centers
- Ppp001 20357 — Beijing
- Ppp001 20137 — Chengdu
- Ppp001 20352 — Chengdu
- Ppp001 20350 — Chongqing
- Ppp001 20311 — Guangzhou
- Ppp001 20313 — Guangzhou
- Ppp001 20022 — Hangzhou
- Ppp001 20193 — Hangzhou
- … and 7 more centers
Poland · 13 centers
- Ppp001 40626 — Bialystok
- Ppp001 40637 — Gdansk
- Ppp001 40878 — Katowice
- Ppp001 40915 — Krakow
- Ppp001 40625 — Lodz
- Ppp001 40757 — Poznan
- Ppp001 40396 — Rzeszów
- Ppp001 40743 — Szczecin
- … and 5 more centers
Germany · 12 centers
- Ppp001 40875 — Ahaus
- Ppp001 40740 — Bad Bentheim
- Ppp001 40515 — Berlin
- Ppp001 40891 — Bielefeld
- Ppp001 40893 — Bochum
- Ppp001 40356 — Dresden
- Ppp001 40866 — Göttingen
- Ppp001 40249 — Kiel
- … and 4 more centers
South Korea · 11 centers
- Ppp001 20366 — Anyang-si
- Ppp001 20211 — Bucheon-si
- Ppp001 20214 — Busan
- Ppp001 20215 — Gwangju
- Ppp001 20367 — Jeonju
- Ppp001 20208 — Seongnam-si
- Ppp001 20104 — Seoul
- Ppp001 20216 — Seoul
- … and 3 more centers
Spain · 9 centers
- Ppp001 40750 — Alicante
- Ppp001 40266 — Badalona
- Ppp001 40885 — Granada
- Ppp001 40888 — Madrid
- Ppp001 40297 — Manises
- … and 4 more centers
Canada · 7 centers
- Ppp001 50233 — Barrie
- Ppp001 50354 — Calgary
- Ppp001 50749 — Fredericton
- Ppp001 50765 — London
- Ppp001 50740 — Québec
- Ppp001 50752 — Red Deer
- Ppp001 50750 — Surrey
United States · 6 centers
- Ppp001 50754 — Birmingham
- Ppp001 50746 — Coral Gables
- Ppp001 50757 — Auburn Hills
- Ppp001 50745 — Columbus
- Ppp001 50202 — Fairborn
- Ppp001 50744 — Oklahoma City
France · 3 centers
- Ppp001 40067 — Lyon
- Ppp001 40874 — Nice
- Ppp001 40887 — Toulon
Hungary · 3 centers
- Ppp001 40203 — Budapest
- Ppp001 40895 — Debrecen
- Ppp001 40894 — Orosháza
Italy · 3 centers
- Ppp001 40816 — Brescia
- Ppp001 40567 — Roma
- Ppp001 40830 — Rozzano
United Kingdom · 3 centers
Center list to be confirmed — check the primary protocol.
Czechia · 1 center
- Ppp001 40881 — Ústí nad Labem
Denmark · 1 center
- Ppp001 40886 — Hellerup
Identifiers
NCT: NCT07219420 · PPP001 · U1111-1322-7183 · 2024-520337-80-00