Recruiting

Delgocitinib Cream for Palmoplantar Pustulosis in Adults

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What is being tested

Delgocitinib cream

+ Vehicle cream

Drug
Who is being recruted

Psoriasis+1

+ Skin Diseases

+ Skin and Connective Tissue Diseases

Over 18 Years
+37 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorLEO Pharma
Study ContactClinical Disclosure
Last updated: January 21, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 11, 2025

Actual date on which the first participant was enrolled.

This study aims to test how well a cream called delgocitinib works for treating adults with a skin condition known as palmoplantar pustulosis (PPP), which affects the palms of the hands and soles of the feet. People with PPP experience painful blisters and inflammation, and this study seeks to find out if the cream can reduce these symptoms. By comparing delgocitinib cream to a placebo cream (which has no active medication), researchers hope to determine if it can be an effective treatment option for those suffering from this condition. Participants in the study apply the delgocitinib cream or a placebo cream twice a day for 16 weeks. The study lasts about 18 weeks in total, including follow-ups, with around nine visits to the research site. The effectiveness of the treatment is monitored by assessing changes in the condition of the skin. Safety is also closely observed to ensure that the cream does not cause harmful effects. This research is crucial as it could provide a new and effective way to relieve symptoms for people dealing with palmoplantar pustulosis.

Official TitleA 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 
NCT07013201
Principal SponsorLEO Pharma
Study ContactClinical Disclosure
Last updated: January 21, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

135 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

PsoriasisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Papulosquamous

Criteria

9 inclusion criteria required to participate
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.
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.
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28 exclusion criteria prevent from participating
Concurrent plaque psoriasis covering >5% of body surface area.
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.
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.
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).
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants with mild to severe PPP will receive 20 mg/g of delgocitinib cream twice a day for 16 weeks.

Group II

Placebo
Participants with mild to severe PPP will receive matching vehicle cream twice a day for 16 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 32 locations

Recruiting

LEO Pharma Investigational Site

Fountain Valley, United StatesSee the location
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LEO Pharma Investigational Site

Douglasville, United States
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LEO Pharma Investigational Site

West Bloomfield, United States
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LEO Pharma Investigational Site

Elmhurst, United States
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32 Study Centers