RecruitingPHASE3INTERVENTIONAL

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

This research study is investigating a new medication, bimekizumab, to see how well it treats palmoplantar pustulosis (PPP) and if it's safe to use. PPP is a skin condition that causes painful pustules on the palms of the hands and/or soles of the feet. Participants will either receive bimekizumab or a placebo (a dummy treatment with no active medicine). The study aims to compare the effects of bimekizumab against the placebo to understand its benefits and any potential side effects for people living with PPP. This is a Phase 3 study, meaning it's a larger study designed to confirm the medicine's effectiveness and safety before it can be considered for wider use.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

UCB Biopharma SRL

Enrolment target

320

Start

14 Nov 2025

Estimated completion

22 Nov 2029

Palmoplantar Pustulosis

What is this study about?

This clinical trial is designed to understand more about a new medicine called bimekizumab and its potential role in treating a specific skin condition known as palmoplantar pustulosis (PPP). PPP causes uncomfortable and often painful outbreaks of pus-filled bumps (pustules) on the palms of your hands and/or the soles of your feet. These pustules can come and go, making daily life challenging for those affected.

The main goal of this study is to compare how effective bimekizumab is at reducing these pustules and other PPP symptoms, against a 'placebo'. A placebo is a dummy treatment that looks like the real medicine but contains no active ingredients. This comparison helps researchers determine if any improvements seen are genuinely due to bimekizumab or if they might have happened anyway. The study will also carefully monitor any side effects to understand the safety of bimekizumab.

This is a Phase 3 study, which means it's a crucial stage in drug development. At this point, the medicine has already gone through earlier safety tests. Now, a larger group of people are involved to confirm the findings from previous stages, gather more information on effectiveness and safety, and compare it against standard approaches. The information gained from this study is vital for potentially making bimekizumab available to a wider group of people with PPP in the future.

Key takeaways

This study evaluates a new medicine, bimekizumab, for palmoplantar pustulosis (PPP).
It aims to see if bimekizumab works better and is safer than a dummy treatment (placebo).
Suitable for adults (18+) with active PPP on their hands or feet.
Participation involves regular clinic visits, assessments, and taking study medication.
Potential benefits include improved PPP symptoms; potential risks include side effects.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have been diagnosed with palmoplantar pustulosis (PPP) for at least six months and have active pustules on your hands or feet at the time of screening. Your PPP symptoms also need to be at a certain level of severity, which the study doctors will assess using specific scoring systems.

There are also some reasons why you might not be able to take part. For example, if your PPP symptoms get significantly better between your initial checks and the start of the study, you might not be eligible. Also, if you have other skin conditions that look similar to PPP or might make it harder for doctors to check your PPP, you might not be able to join. These include conditions like certain types of psoriasis not related to PPP, or severe eczema affecting your hands.

Finally, if you're taking or have recently taken certain medications, especially particular treatments for psoriasis or if you've been in a study for bimekizumab before, you might not be able to participate. The study team will carefully review all your medical information to make sure it's safe and appropriate for you to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with palmoplantar pustulosis (PPP) for at least 6 months?
Do you currently have active pustules on your palms and/or soles?
Are your PPP symptoms severe enough that your doctor would consider systemic treatment or light therapy?
Have you avoided specific medications that might interfere with the study?
Have you never taken bimekizumab or participated in a bimekizumab study before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the clinic for assessments. These visits will involve checks of your skin condition, blood tests, and possibly other examinations to monitor your health and how the treatment is affecting you. You will be given either the study medicine (bimekizumab) or a placebo, which you will take as instructed by the study team.

Throughout the study, the research team will closely monitor your PPP symptoms, any side effects you might experience, and your overall well-being. There will be a follow-up period after you finish taking the study medication to ensure your health is stable. The total duration of your participation, including all visits and follow-ups, will be explained in detail by the study team, but typically, Phase 3 studies run for several months to over a year.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. You might benefit from receiving a new medication that could improve your palmoplantar pustulosis symptoms. However, there's also a chance you might receive the placebo, which won't contain active medicine, and your condition may not improve. Bimekizumab, like any medication, may have side effects, which the study team will monitor closely. You will be given full details of any known side effects before you agree to take part. Remember, joining a study is always voluntary, and you have the right to withdraw at any time without giving a reason, and your medical care will not be affected.

Locations (41)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Ppp001 50233
Verified postcode
Barrie, Canada· Recruiting
Ppp001 50749
Verified postcode
Fredericton, Canada· Recruiting
Ppp001 50765
Verified postcode
London, Canada· Recruiting
Ppp001 50740
Verified postcode
Québec, Canada· Recruiting
Ppp001 50752
Verified postcode
Red Deer, Canada· Recruiting
Ppp001 50750
Verified postcode
Surrey, Canada· Recruiting
Ppp001 20357
Verified postcode
Beijing, China· Recruiting
Ppp001 20137
Verified postcode
Chengdu, China· Recruiting
Ppp001 20352
Verified postcode
Chengdu, China· Recruiting
Ppp001 20350
Verified postcode
Chongqing, China· Recruiting
Ppp001 20313
Verified postcode
Guangzhou, China· Recruiting
Ppp001 20022
Verified postcode
Hangzhou, China· Recruiting

Common questions

What is palmoplantar pustulosis (PPP)?

PPP is a skin condition that causes pus-filled bumps (pustules) on the palms of your hands and/or the soles of your feet.

What is bimekizumab?

Bimekizumab is the new medicine being tested in this study to see if it helps treat PPP.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real medicine but doesn't contain any active ingredients. It's used to compare against the new medicine.

How long will the study last?

The total duration of your participation, including all visits and follow-ups, will be explained by the study team.

Can I leave the study at any time?

Yes, your participation is completely voluntary, and you can withdraw from the study at any time without affecting your medical care.

How to find out more

UCB Cares

ucbcares@ucb.com +18445992273 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.