Delgocitinib Cream for Palmoplantar Pustulosis in Adults

What is being tested

Delgocitinib cream

+ Vehicle cream

Drug

Who is being recruted

Palmoplantar Pustulosis

Over 18 Years

+37 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled

Phase 2

Interventional

Study Start: September 2025

See protocol details

Summary

Principal SponsorLEO Pharma

Study ContactClinical Disclosure

Last updated: October 15, 2025

Sourced from a government-validated database.Claim as a partner

Study start date: September 11, 2025Actual 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

Principal SponsorLEO Pharma

Study ContactClinical Disclosure

Last updated: October 15, 2025

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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

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

Conditions

Criteria

Any sexBiological sex of participants that are eligible to enroll.

Over 18 YearsRange of ages for which participants are eligible to join.

Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Palmoplantar Pustulosis

Criteria

9 inclusion criteria required to participate

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).

Participants with prior experiences of inadequate response with topical corticosteroid(s) (TCS) or for whom TCS are inadvisable, as judged by the investigators.

Presence of ≥5 well-demarcated fresh pustules (white or yellow pustules) in total across all affected areas at screening and baseline.

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.

Show More Criteria

28 exclusion criteria prevent from participating

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.

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.

Previously randomised in a clinical trial with delgocitinib.

Show More Criteria

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

An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.

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 21 locations

Recruiting

LEO Pharma Investigational SiteFountain Valley, United StatesSee the location

Recruiting

LEO Pharma Investigational SiteDouglasville, United States

Recruiting

LEO Pharma Investigation SiteMayfield Heights, United States

Recruiting

LEO Pharma Investigational SiteMayfield Heights, United States

Recruiting

21 Study Centers

Delgocitinib Cream for Palmoplantar Pustulosis in Adults