A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis
NCT ID: NCT07219420
Last Updated: 2026-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2025-11-14
2029-10-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Bimekizumab
Subjects randomized to this arm will receive the bimekizumab dosing regimen for the entire duration of the study.
Bimekizumab
Study participants will receive bimekizumab at pre-specified time points.
Placebo
Subjects randomized to this arm will receive placebo during the initial treatment period before transitioning to bimekizumab in the maintenance treatment period.
Placebo
Study participants will receive matching placebo at pre-specified time points.
Interventions
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Bimekizumab
Study participants will receive bimekizumab at pre-specified time points.
Placebo
Study participants will receive matching placebo at pre-specified time points.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 22733 (UCB)
Locations
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Ppp001 50233
Barrie, , Canada
Ppp001 50749
Fredericton, , Canada
Ppp001 50740
Québec, , 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 40886
Hellerup, , Denmark
Ppp001 40875
Ahaus, , Germany
Ppp001 40893
Bochum, , Germany
Ppp001 40895
Debrecen, , Hungary
Ppp001 40894
Orosháza, , Hungary
Ppp001 40625
Lodz, , Poland
Ppp001 40757
Poznan, , Poland
Ppp001 40604
Warsaw, , Poland
Ppp001 40862
Wroclaw, , Poland
Ppp001 40889
Málaga, , Spain
Countries
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Central Contacts
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Other Identifiers
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U1111-1322-7183
Identifier Type: REGISTRY
Identifier Source: secondary_id
PPP001
Identifier Type: -
Identifier Source: org_study_id
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