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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-14

Study Completion Date

2029-10-29

Brief Summary

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

Detailed Description

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Conditions

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Palmoplantar Pustulosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Group Type EXPERIMENTAL

Bimekizumab

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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BIMZELX, UCB4940 PLB

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Biopharma SRL

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Ppp001 50749

Fredericton, , Canada

Site Status RECRUITING

Ppp001 50740

Québec, , Canada

Site Status RECRUITING

Ppp001 20357

Beijing, , China

Site Status RECRUITING

Ppp001 20137

Chengdu, , China

Site Status RECRUITING

Ppp001 20352

Chengdu, , China

Site Status RECRUITING

Ppp001 20350

Chongqing, , China

Site Status RECRUITING

Ppp001 20313

Guangzhou, , China

Site Status RECRUITING

Ppp001 20022

Hangzhou, , China

Site Status RECRUITING

Ppp001 20355

Jinan, , China

Site Status RECRUITING

Ppp001 20345

Shanghai, , China

Site Status RECRUITING

Ppp001 20184

Shenzhen, , China

Site Status RECRUITING

Ppp001 40886

Hellerup, , Denmark

Site Status RECRUITING

Ppp001 40875

Ahaus, , Germany

Site Status RECRUITING

Ppp001 40893

Bochum, , Germany

Site Status RECRUITING

Ppp001 40895

Debrecen, , Hungary

Site Status RECRUITING

Ppp001 40894

Orosháza, , Hungary

Site Status RECRUITING

Ppp001 40625

Lodz, , Poland

Site Status RECRUITING

Ppp001 40757

Poznan, , Poland

Site Status RECRUITING

Ppp001 40604

Warsaw, , Poland

Site Status RECRUITING

Ppp001 40862

Wroclaw, , Poland

Site Status RECRUITING

Ppp001 40889

Málaga, , Spain

Site Status RECRUITING

Countries

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Canada China Denmark Germany Hungary Poland Spain

Central Contacts

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UCB Cares

Role: CONTACT

+18445992273

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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