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A Study Testing How Well Bimekizumab Works and How Safe It Is for Adults with Palmoplantar Pustulosis

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at a condition called palmoplantar pustulosis, which is a skin disease that causes painful blisters filled with fluid to appear on the palms of the hands and soles of the feet. People with this condition often experience pain and discomfort that can affect their daily activities and quality of life. The treatment being tested in this study is called bimekizumab, which is given as an injection under the skin. Some people in the study will receive bimekizumab while others will receive placebo. The purpose of the study is to evaluate the efficacy of bimekizumab compared with placebo in participants with palmoplantar pustulosis at Week 16.

During the study, participants will receive their assigned treatment through injections that are given using pre-filled syringes or pre-filled pens. The study will measure how well the treatment works by looking at changes in the skin condition, including the number and severity of pustules on the hands and feet. Doctors will use specific scoring systems to track improvements in the skin. The study will also look at how the treatment affects pain levels and quality of life by asking participants to complete questionnaires about their symptoms and how the condition impacts their daily activities.

The study has two parts: a main treatment period and an open-label extension period where all participants may receive the active treatment. Throughout the study, doctors will carefully monitor participants for any side effects or unwanted reactions to the treatment. They will track all health problems that occur during the study, including serious health issues and any problems that might cause participants to stop taking the study treatment. Regular check-ups and assessments will be conducted to ensure participant safety and to measure how well the treatment is working over time.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit and treatment start

    At the baseline visit, your palmoplantar pustulosis (a skin condition causing pustules on palms and soles) will be assessed using specific scoring systems to measure the severity of your condition.

    Your skin will be evaluated to confirm that you have pustules on the palms of your hands and soles of your feet, with specific criteria regarding the number and severity of pustules.

    You will be randomly assigned to receive either bimekizumab or placebo (an inactive substance). This is a double-blind study, which means neither you nor your doctor will know which treatment you are receiving during the initial phase.

    You will begin receiving your assigned treatment through subcutaneous injection (injection under the skin). The medication will be administered using either a pre-filled syringe or a pre-filled pen.

  2. Step 2

    Treatment period from baseline to week 8

    You will continue receiving your assigned treatment (either bimekizumab or placebo) through subcutaneous injections according to the study schedule.

    The treatment may be administered as 160 mg or 320 mg doses, depending on the study protocol.

    At week 8, your skin condition will be assessed to evaluate how well the treatment is working. This will include measuring the reduction in pustules and overall severity of your condition.

  3. Step 3

    Treatment period from week 8 to week 16

    You will continue receiving your assigned treatment through subcutaneous injections.

    Your condition will be monitored throughout this period for any changes in symptoms and any side effects that may occur.

  4. Step 4

    Week 16 assessment

    At week 16, a comprehensive assessment of your skin condition will be performed. This is the primary evaluation point of the study.

    Your doctor will assess whether your skin has cleared or almost cleared using the PPP-IGA (Palmoplantar Pustulosis-Investigator Global Assessment) scoring system.

    The improvement in your condition will be measured using the PPPASI (Palmoplantar Pustulosis Area Severity Index) to determine the percentage reduction in severity.

    You will complete questionnaires about how your skin condition affects your quality of life using the DLQI (Dermatology Life Quality Index).

    You will be asked to rate your pain in the palmoplantar areas using a numerical scale.

  5. Step 5

    Open-label extension period

    After week 16, you may be eligible to enter an open-label extension phase. During this phase, all participants will know they are receiving bimekizumab (not placebo).

    You will continue to receive bimekizumab through subcutaneous injections.

    Regular monitoring visits will continue to assess the effectiveness of the treatment and monitor for any side effects.

  6. Step 6

    Safety follow-up period

    After completing the treatment period, you will enter a safety follow-up period.

    During this time, you will be monitored for any adverse events (unwanted or harmful effects) that may occur after stopping the study treatment.

    Any serious side effects or events that led to stopping the treatment will be recorded and evaluated.

Who can join the trial?

6 criteria

  • You must be at least 18 years old or older when you sign the consent form to join the study.
  • You must have been diagnosed with palmoplantar pustulosis (a skin condition that causes small pus-filled bumps on the palms of your hands and soles of your feet) for at least 24 weeks (about 6 months) before the first study visit.
  • You must have a PPPASI score of 12 or higher at both the first visit and the starting visit. PPPASI is a scoring system that measures how severe and widespread your skin condition is on your palms and soles.
  • You must have a PPP-IGA score of 3 or higher at both the first visit and the starting visit. PPP-IGA is a score given by the doctor to rate the overall severity of your skin condition.
  • You must have pustules (small bumps filled with pus) on the palms of your hands or soles of your feet at both the first visit and the starting visit. This means at least one area must have a pustule severity score of 2 or higher, and you must have more than 5 active white-yellow pustules across all areas.
  • You must be someone who could benefit from systemic therapy (medicine that works throughout your whole body) or phototherapy (treatment using special light).

Who cannot join the trial?

3 criteria

  • The study does not list specific exclusion criteria in the provided information, which means the detailed reasons why someone cannot participate are not available in this document.
  • Generally, clinical trials have exclusion criteria to ensure patient safety and study accuracy, but these specific details would need to be obtained from the complete study documentation.
  • If you have questions about whether you can participate, the research team would need to review your individual medical situation against their full list of requirements.
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Investigated drugs

  • Bimekizumab

    is a medication being tested in this study to treat palmoplantar pustulosis, which is a skin condition that causes painful blisters and pustules on the palms of the hands and soles of the feet. This medicine works by blocking certain proteins in the body that cause inflammation and skin problems. Participants in the study will receive this medication to see if it can help improve their skin condition.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active medicine. Some participants will receive placebo instead of the actual medication so that researchers can compare the results and determine if the real medication is truly effective in treating the condition.

What is already known about the treatment

Bimekizumab – Bimekizumab is an injectable medication given under the skin that is currently being studied in clinical trials for the treatment of palmoplantar pustulosis, a chronic skin condition that causes painful blisters and pustules on the palms of the hands and soles of the feet. This medication works by blocking two specific proteins in the body called interleukin-17A and interleukin-17F, which are responsible for causing inflammation and triggering the immune system to attack healthy skin cells. It belongs to a class of drugs known as biologic therapies or monoclonal antibodies, which are designed to target specific parts of the immune system to reduce inflammation and improve symptoms.

Investigated diseases

Palmoplantar Pustulosis – Palmoplantar pustulosis is a chronic skin condition that affects the palms of the hands and soles of the feet. The disease is characterized by the repeated appearance of small, pus-filled blisters called pustules on the skin of these areas. These pustules typically develop on reddened, thickened skin and may cause pain and discomfort. Over time, the pustules dry out and form brown scales or crusts, but new pustules continue to appear in cycles. The affected skin often becomes cracked and painful, which can interfere with daily activities such as walking or using the hands. The condition follows a relapsing course, with periods of flare-ups alternating with periods of relative improvement.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520337-80-00Protocol codePPP001Estimated enrolment380 patientsSponsorUCB Biopharma

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).