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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to Severe Palmoplantar Pustulosis

A Proof-of-concept Phase 2a, Double-blind, 2-arm Trial to Investigate the Efficacy and Safety of Twice Daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle During a 16-week Treatment Period in Adult Subjects With Mild to Severe Palmoplantar Pustulosis

A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to Severe Palmoplantar Pustulosis (NCT07013201) is a Phase 2 interventional studying Palmoplantar Pustulosis, sponsored by LEO Pharma. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The main objective of the study is to evaluate the efficacy of twice daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adult participants with mild to severe palmoplantar pustulosis (PPP). Total study duration for each participants will be approximately 18 weeks, for an approximate total of 9 visits.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Palmoplantar Pustulosis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 135 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Palmoplantar Pustulosis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Signed and dated willing to sign a consent form has been obtained prior to any protocol-related procedures. - Age 18 years or above at the time of willing to sign a consent form 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). Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Delgocitinib cream

Topical application

DRUG

Vehicle cream

Topical application

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

LEO Pharma Investigational Site
Fountain Valley, California, United States
LEO Pharma Investigational Site
Douglasville, Georgia, United States
LEO Pharma Investigational Site
West Bloomfield, Michigan, United States
LEO Pharma Investigational Site
Elmhurst, New York, United States
LEO Pharma Investigation Site
Mayfield Heights, Ohio, United States
LEO Pharma Investigational Site
Portland, Oregon, United States
LEO Pharma Investigational Site
Philadelphia, Pennsylvania, United States
LEO Pharma Investigational Site
Surrey, British Columbia, Canada
LEO Pharma Investigational Site
Winnipeg, Manitoba, Canada
LEO Pharma Investigational Site
Fredericton, New Brunswick, Canada
LEO Pharma Investigational Site
Hamilton, Ontario, Canada
LEO Pharma Investigational Site
Hamilton, Ontario, Canada
LEO Pharma Investigational Site
Markham, Ontario, Canada
LEO Pharma Investigational Site
Waterloo, Ontario, Canada
LEO Pharma Investigational Site
Montreal, Quebec, Canada
LEO Pharma Investigational Site
Bad Bentheim, Germany
LEO Pharma Investigational Site
Dresden, Germany
LEO Pharma Investigational Site
Göttingen, Germany
LEO Pharma Investigational Site
Kiel, Germany
LEO Pharma Investigational Site
Lübeck, Germany

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07013201), the sponsor (LEO Pharma), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07013201 clinical trial studying?

The main objective of the study is to evaluate the efficacy of twice daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adult participants with mild to severe palmoplantar pustulosis (PPP). Total study duration for each participants will be approximately 18 weeks, for an approximate total of 9 visits. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07013201?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07013201?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07013201. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07013201. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.