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Looking for participantsPhase3

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis

Sponsor: UCB Biopharma SRL

NCT ID: NCT07219420

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Bimekizumab (drug), Placebo (drug)
How long the study runs
Study runs about 48 months (dates as stated)
About the drug or intervention
Bimekizumab — drug: Study participants will receive bimekizumab at pre-specified time points. · Placebo — drug: Study participants will receive matching placebo at pre-specified time points.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at how well a medicine called bimekizumab works and how safe it is for adults with palmoplantar pustulosis, a condition that causes pustules (small fluid-filled bumps) on the palms of the hands and/or the soles of the feet. The study is being run by UCB Biopharma SRL. Whether it fully works or is safe is what the study aims to find out.

Who can take part

  • You are at least 18 years old when you sign the consent form
  • You have had palmoplantar pustulosis for at least 24 weeks before the screening visit
  • Your condition scores at screening and baseline are high enough (PPPASI of 12 or more and PPP-IGA of 3 or more) — these are measures of how severe your palmoplantar pustulosis is
  • You have pustules on your palms and/or soles at screening and baseline, with more than 5 active pustules of a certain severity
  • You are someone who could be offered treatment by mouth or injection (systemic therapy) or light treatment (phototherapy)

Who may not be able to

  • Your symptoms improve a lot between the screening visit and the baseline visit
  • You have certain other skin conditions, such as plaque psoriasis on the palms or soles, guttate psoriasis, erythrodermic psoriasis, generalised pustular psoriasis, a condition called Acrodermatitis continua of Hallopeau, atopic dermatitis, dyshidrotic eczema, or long-term hand eczema
  • Your pustulosis or psoriasis was caused or made worse by certain medicines (for example beta blockers, some blood pressure medicines called calcium channel inhibitors, lithium, or medicines called TNF inhibitors)
  • You have skin marks or problems that could make it hard for the study team to assess your palmoplantar pustulosis
  • You are taking, or have taken, medicines that are not allowed in the study, or you have not stopped them for the required time before the baseline visit
  • You are taking or have ever taken a medicine that blocks interleukin-17A and interleukin-17F (natural substances in the body), including bimekizumab, or you have taken part in an earlier study of bimekizumab

What taking part involves

  • • Not stated — ask the trial team. The study tests a medicine called bimekizumab, but details of how it is given and what dose are not stated.

Time commitment: Not stated — ask the trial team. The study involves at least two visits (a screening visit and a baseline visit) before starting, but the total number of visits and how long the study lasts are not stated.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
320
Started
2025-11-14
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for palmoplantar pustulosis
  • • Phase3 - 320 participants
  • • The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with palmoplantar pustulosis

Where?

  • • London - Ppp001 40113
  • • London - Ppp001 40880
  • • Salford - Ppp001 40108

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Palmoplantar Pustulosis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓At least 18 years of age inclusive, at the time of signing the agreement to take part 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...

Who cannot take part

  • ✗Has PPP symptoms which improve significantly between the Screening Visit and Baseline Visit, defined as a reduction...
  • ✗Has cutaneous lesions that may interfere with the evaluation of the affected area and/or evaluation of the severity...
  • ✗Is taking or has taken prohibited or restricted medications without meeting the mandatory discontinuation or...
  • ✗Is taking or has ever taken an interleukin (IL)-17A/IL-17F inhibitor, including bimekizumab, or has participated in...
See the full 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

Where Is This Study? (3 UK sites)

Ppp001 40113

London, United Kingdom

Recruiting

Ppp001 40880

London, United Kingdom

Recruiting

Ppp001 40108

Salford, United Kingdom

Recruiting

How to Get in Touch

UCB Cares

Sponsor contact

CONTACT

+18445992273 ucbcares@ucb.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08