New hope for painful hand and foot pustules: phase 3 trial launches
NCT ID NCT07219420
First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 6 times
Summary
This phase 3 trial tests whether the drug bimekizumab can clear or nearly clear the pustules and skin lesions of palmoplantar pustulosis (PPP) on the hands and feet. About 320 adults with moderate to severe PPP will receive either bimekizumab or a placebo for 16 weeks, with an option to continue on the drug afterward. The main goal is to see how many achieve clear or almost clear skin at week 16.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bimekizumab (BIMZELX)
- What this could lead to
- If it works, this could provide a new treatment option for people with painful pustules on hands and feet.
- What could go wrong
- This is a late-stage trial, but results may not apply to all patients. Side effects are possible, and the drug may not work better than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 320 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
91 sites in 13 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ppp001 20022
RECRUITINGHangzhou, China
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Ppp001 20104
RECRUITINGSeoul, South Korea
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Ppp001 20136
RECRUITINGTianjin, China
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Ppp001 20137
RECRUITINGChengdu, China
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Ppp001 20184
RECRUITINGShenzhen, China
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Ppp001 20193
RECRUITINGHangzhou, China
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Ppp001 20208
RECRUITINGSeongnam-si, South Korea
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Ppp001 20211
RECRUITINGBucheon-si, South Korea
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Ppp001 20214
RECRUITINGBusan, South Korea
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Ppp001 20215
RECRUITINGGwangju, South Korea
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Ppp001 20216
RECRUITINGSeoul, South Korea
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Ppp001 20220
RECRUITINGSeoul, South Korea
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Ppp001 20311
RECRUITINGGuangzhou, China
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Ppp001 20313
RECRUITINGGuangzhou, China
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Ppp001 20344
RECRUITINGJinan, China
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Ppp001 20345
RECRUITINGShanghai, China
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Ppp001 20350
RECRUITINGChongqing, China
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Ppp001 20351
RECRUITINGSeoul, South Korea
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Ppp001 20352
RECRUITINGChengdu, China
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Ppp001 20353
RECRUITINGYinchuan, China
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Ppp001 20354
RECRUITINGSeoul, South Korea
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Ppp001 20355
RECRUITINGJinan, China
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Ppp001 20356
RECRUITINGXi'an, China
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Ppp001 20357
RECRUITINGBeijing, China
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Ppp001 20359
RECRUITINGSeoul, South Korea
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Ppp001 20366
RECRUITINGAnyang-si, South Korea
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Ppp001 20367
RECRUITINGJeonju, South Korea
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Ppp001 40067
RECRUITINGLyon, France
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Ppp001 40108
RECRUITINGSalford, United Kingdom
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Ppp001 40113
RECRUITINGLondon, United Kingdom
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Ppp001 40177
RECRUITINGMünster, Germany
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Ppp001 40203
RECRUITINGBudapest, Hungary
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Ppp001 40230
RECRUITINGValencia, Spain
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Ppp001 40249
RECRUITINGKiel, Germany
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Ppp001 40266
RECRUITINGBadalona, Spain
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Ppp001 40297
RECRUITINGManises, Spain
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Ppp001 40334
RECRUITINGWroclaw, Poland
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Ppp001 40356
RECRUITINGDresden, Germany
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Ppp001 40366
RECRUITINGRostock, Germany
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Ppp001 40396
RECRUITINGRzeszów, Poland
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Ppp001 40515
RECRUITINGBerlin, Germany
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Ppp001 40567
RECRUITINGRoma, Italy
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Ppp001 40604
RECRUITINGWarsaw, Poland
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Ppp001 40625
RECRUITINGLodz, Poland
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Ppp001 40626
RECRUITINGBialystok, Poland
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Ppp001 40637
RECRUITINGGdansk, Poland
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Ppp001 40740
RECRUITINGBad Bentheim, Germany
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Ppp001 40743
RECRUITINGSzczecin, Poland
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Ppp001 40747
RECRUITINGMainz, Germany
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Ppp001 40748
RECRUITINGPlzen-bory, Czechia
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Ppp001 40750
RECRUITINGAlicante, Spain
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Ppp001 40757
RECRUITINGPoznan, Poland
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Ppp001 40788
RECRUITINGTorun, Poland
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Ppp001 40816
RECRUITINGBrescia, Italy
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Ppp001 40830
RECRUITINGRozzano, Italy
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Ppp001 40862
RECRUITINGWroclaw, Poland
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Ppp001 40866
RECRUITINGGöttingen, Germany
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Ppp001 40868
RECRUITINGValencia, Spain
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Ppp001 40874
RECRUITINGNice, France
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Ppp001 40875
RECRUITINGAhaus, Germany
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Ppp001 40876
RECRUITINGWarsaw, Poland
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Ppp001 40878
RECRUITINGKatowice, Poland
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Ppp001 40879
RECRUITINGSantiago de Compostela, Spain
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Ppp001 40880
RECRUITINGLondon, United Kingdom
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Ppp001 40881
RECRUITINGÚstí nad Labem, Czechia
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Ppp001 40885
RECRUITINGGranada, Spain
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Ppp001 40886
RECRUITINGHellerup, Denmark
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Ppp001 40887
RECRUITINGToulon, France
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Ppp001 40888
RECRUITINGMadrid, Spain
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Ppp001 40889
RECRUITINGMálaga, Spain
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Ppp001 40891
RECRUITINGBielefeld, Germany
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Ppp001 40892
RECRUITINGLübeck, Germany
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Ppp001 40893
RECRUITINGBochum, Germany
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Ppp001 40894
RECRUITINGOrosháza, Hungary
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Ppp001 40895
RECRUITINGDebrecen, Hungary
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Ppp001 40915
RECRUITINGKrakow, Poland
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Ppp001 50176
RECRUITINGFremont, California, 94538, United States
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Ppp001 50202
RECRUITINGFairborn, Ohio, 45324, United States
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Ppp001 50233
RECRUITINGBarrie, Canada
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Ppp001 50354
RECRUITINGCalgary, Canada
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Ppp001 50733
RECRUITINGMayfield Heights, Ohio, 44124, United States
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Ppp001 50740
RECRUITINGQuébec, Canada
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Ppp001 50744
RECRUITINGOklahoma City, Oklahoma, 73170, United States
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Ppp001 50745
RECRUITINGColumbus, Ohio, 43213, United States
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Ppp001 50746
RECRUITINGMiami, Florida, 33126, United States
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Ppp001 50749
RECRUITINGFredericton, Canada
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Ppp001 50750
RECRUITINGSurrey, Canada
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Ppp001 50752
RECRUITINGRed Deer, Canada
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Ppp001 50754
RECRUITINGBirmingham, Alabama, 35205, United States
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Ppp001 50757
RECRUITINGAuburn Hills, Michigan, 48326, United States
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Ppp001 50765
RECRUITINGLondon, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug picankibart aims to treat stubborn hand and foot pustules
- Scientists seek skin samples to unlock secrets of common rashes
- New drug hope for painful hand and foot pustules
- AI boosts doctor accuracy for rare skin diseases in new study
- Promising drug for hand and foot blisters falls short in early trial
- Spesolimab shows promise for Long-Term control of painful hand and foot pustules