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New cream shows promise for painful hand and foot pustules

NCT ID NCT07013201

Disease control Sponsor: LEO Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 4 times

Summary

This study tests a cream called delgocitinib for people with mild to severe palmoplantar pustulosis, a skin condition causing painful pus-filled blisters on hands and feet. About 135 adults will apply the cream twice daily for 16 weeks. The main goal is to see if the cream reduces symptoms by at least 75% compared to a placebo cream.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 135 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed and dated informed consent has been obtained prior to any protocol-related procedures. * Age 18 years or above at the time of informed consent signing. * Participant is able to comply with clinic visits and trial requirements and procedures, as assessed by the investigator. * Diagnosis of PPP in accordance with the consensus diagnostic criteria established by European Rare and Severe Psoriasis Expert Network: primary, persistent (\>3 months duration), sterile, macroscopically visible pustules on the palms and/or soles, with or without plaque psoriasis elsewhere on the body. * Confirmed PPP by central evaluation of photographs taken at screening. * Mild to severe PPP current condition defined by: * Disease duration of PPP of \>6 months before randomisation. * PPP-PGA of at least mild severity (PPP-PGA ≥2) at screening and baseline. * PPPASI ≥8 at screening and baseline. * Presence of ≥5 well-demarcated fresh pustules (white or yellow pustules) in total across all affected areas at screening and baseline. * Participants with prior experiences of inadequate response with topical corticosteroid(s) (TCS) or for whom TCS are inadvisable, as judged by the investigators. * A woman of childbearing potential must use an acceptable form of birth control throughout the trial up until the last administration of investigational medicinal product (IMP). Exclusion Criteria: * Presence or known history of drug-induced PPP (e.g., a new onset of PPP or an exacerbation of PPP from beta blockers, calcium channel blockers, lithium, or biologic therapy including infliximab, adalimumab, or etanercept). * Presence of acrodermatitis continua of Hallopeau. * Active dermatologic condition that could confound the diagnosis of PPP or interfere with assessment of the IMP, as assessed by the investigator. * Clinically significant infection on the palms or soles. * Concurrent plaque psoriasis covering \>5% of body surface area. * Clinically significant infection within 4 weeks prior to baseline, which, in the opinion of the investigator, may compromise the safety of the participant in the trial, interfere with evaluation of the IMP, or reduce the participant's ability to participate in the trial. Clinically significant infections are defined as: * A systemic infection. * A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication. * History of any known primary immunodeficiency disorder, including a positive human immunodeficiency virus test at screening, or the participant taking antiretroviral medications as determined by medical history and/or the participant's verbal report. * Major surgery within 8 weeks prior to screening or planned in-patient surgery or hospitalisation during the trial period. * Any documented active or suspected malignancy, or history of malignancy within 5 years prior to screening, except basal cell carcinoma of the skin, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix appropriately treated before the baseline visit. * Any disorder that is not stable and could: * Affect the safety of the participant throughout the trial. * Impede the participant's ability to complete the trial. Examples include, but are not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, and psychiatric disorders, as well as major physical impairment. * Any clinically significant abnormal finding occurring during the screening period and/or observed at the baseline visit that may put the participant at risk due to their participation in the trial or could influence the participant's ability to complete the trial. * Positive hepatitis B surface antigen and/or hepatitis B core antibody and positive hepatitis B virus DNA (participants who have tested positive for hepatitis B core antibody are eligible if tests for hepatitis B surface antigen and hepatitis B virus DNA are negative) or positive hepatitis C virus antibody serology confirmed by hepatitis C virus RNA at screening. * Known or suspected hypersensitivity to any component(s) of the IMP. * Current or recent chronic alcohol or drug abuse, or any other condition associated with poor compliance as judged by the investigator. * Women who are pregnant or lactating. * Systemic treatment within 4 weeks prior to baseline with immunosuppressive drugs (e.g., methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g., acitretin), tyrosine kinase inhibitors, phosphodiesterase-4 inhibitors, or corticosteroids (steroid eye drops and inhaled or intranasal steroids in the doses recommended in the product prescribing information for the treatment of allergic conjunctivitis, asthma, or rhinitis are allowed). * Use of tanning beds or phototherapy (e.g., ultraviolet B \[UVB\], ultraviolet A1 \[UVA1\], psoralen ultraviolet A \[PUVA\]) on the palms or soles within 4 weeks prior to baseline. * Use of systemic or topical janus kinase inhibitors (including delgocitinib/LEO 124249) within 4 weeks prior to baseline. * Cutaneously applied treatment with immunomodulators (e.g., phosphodiesterase-4 \[PDE-4\] inhibitors, pimecrolimus, tacrolimus, tapinarof, vitamin D3 derivatives) or TCS on the palms or soles within 2 weeks prior to baseline. * Use of systemic antibiotics or cutaneously applied antibiotics on the palms or soles within 2 weeks prior to baseline. * Other transdermal or cutaneously applied therapy on the palms or soles (except for the use of the participant's own non-medicated emollients) within 1 week prior to baseline. * Cutaneously applied treatments in regions other than the palms or soles, which could interfere with clinical trial evaluations or pose a safety concern (excluding treatments for psoriasis patches or other non-exclusionary skin conditions, if needed) within 1 week prior to baseline. * Treatment with any marketed biological therapy or investigational biologic agents: * Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer. * Other biologics, including but not limited to secukinumab, ustekinumab, tildrakizumab, ixekizumab, risankizumab, guselkumab, and tumour necrosis factor (TNF)-alpha inhibitors: within 3 months or 5 half-lives, whichever is longer, prior to baseline. * Treatment with any non-marketed drug substance (i.e., an agent that has not yet been made available for clinical use following registration) within the last 4 weeks prior to baseline or 5 half-lives, whichever is longer. * Current participation in any other interventional clinical trial. * Previously randomised in this clinical trial. * Previously randomised in a clinical trial with delgocitinib. * Employees of the trial site, or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals.

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Conditions

The condition(s) this trial relates to.

palmoplantar pustulosis psoriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Palmoplantar pustulosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    38 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • LEO Pharma Investigation Site

    RECRUITING

    Mayfield Heights, Ohio, 44124, United States

  • LEO Pharma Investigational Site

    RECRUITING

    Fountain Valley, California, 92708, United States

  • LEO Pharma Investigational Site

    RECRUITING

    Douglasville, Georgia, 30135, United States

  • LEO Pharma Investigational Site

    RECRUITING

    West Bloomfield, Michigan, 48322, United States

  • LEO Pharma Investigational Site

    RECRUITING

    Elmhurst, New York, 11373, United States

  • LEO Pharma Investigational Site

    RECRUITING

    Portland, Oregon, 97201, United States

  • LEO Pharma Investigational Site

    RECRUITING

    Philadelphia, Pennsylvania, 19103, United States

  • LEO Pharma Investigational Site

    RECRUITING

    Calgary, Alberta, T3A 2N1, Canada

  • LEO Pharma Investigational Site

    RECRUITING

    Edmonton, Alberta, T6W 4V4, Canada

  • LEO Pharma Investigational Site

    RECRUITING

    Surrey, British Columbia, V3R 6A7, Canada

  • LEO Pharma Investigational Site

    RECRUITING

    Winnipeg, Manitoba, R3M 3Z4, Canada

  • LEO Pharma Investigational Site

    RECRUITING

    Fredericton, New Brunswick, E3B 1G9, Canada

  • LEO Pharma Investigational Site

    RECRUITING

    Hamilton, Ontario, L8L 3C3, Canada

  • LEO Pharma Investigational Site

    COMPLETED

    Hamilton, Ontario, L8N 1Y2, Canada

  • LEO Pharma Investigational Site

    RECRUITING

    Markham, Ontario, L3P 1X2, Canada

  • LEO Pharma Investigational Site

    RECRUITING

    Waterloo, Ontario, N2J 1C4, Canada

  • LEO Pharma Investigational Site

    RECRUITING

    Montreal, Quebec, H2X 2V1, Canada

  • LEO Pharma Investigational Site

    RECRUITING

    Bad Bentheim, 48455, Germany

  • LEO Pharma Investigational Site

    RECRUITING

    Dresden, 01097, Germany

  • LEO Pharma Investigational Site

    RECRUITING

    Göttingen, 37075, Germany

  • LEO Pharma Investigational Site

    RECRUITING

    Kiel, 24105, Germany

  • LEO Pharma Investigational Site

    RECRUITING

    Lübeck, 23562, Germany

  • LEO Pharma Investigational Site

    RECRUITING

    Manheim, 68167, Germany

  • LEO Pharma Investigational Site

    RECRUITING

    Münster, 48149, Germany

  • LEO Pharma Investigational Site

    RECRUITING

    Osnabrück, 49074, Germany

  • LEO Pharma Investigational Site

    RECRUITING

    Witten, 58453, Germany

  • LEO Pharma Investigational Site

    RECRUITING

    Bialystok, 15-879, Poland

  • LEO Pharma Investigational Site

    RECRUITING

    Iwonicz-Zdrój, 38-440, Poland

  • LEO Pharma Investigational Site

    RECRUITING

    Lodz, 90-436, Poland

  • LEO Pharma Investigational Site

    RECRUITING

    Lublin, 20-011, Poland

  • LEO Pharma Investigational Site

    RECRUITING

    Rzeszów, 35-055, Poland

  • LEO Pharma Investigational Site

    RECRUITING

    Warsaw, 02-482, Poland

  • LEO Pharma Investigational Site

    RECRUITING

    Wroclaw, 50-556, Poland

  • LEO Pharma Investigational Site

    RECRUITING

    Wroclaw, 50-566, Poland

  • LEO Pharma Investigational Site

    RECRUITING

    Bristol, BS2 8HW, United Kingdom

  • LEO Pharma Investigational Site

    RECRUITING

    London, SE1 9RT, United Kingdom

  • LEO Pharma Investigational Site

    RECRUITING

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • LEO Pharma Investigational Site

    RECRUITING

    Salford, M6 8HD, United Kingdom

  • LEO Pharma Investigational Site

    RECRUITING

    Stourbridge, DY8 4JB, United Kingdom

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Other studies related to the condition(s) this trial covers.