What is delgocitinib cream studying for palmoplantar pustulosis?

Delgocitinib cream is being studied to see how well it works for treating palmoplantar pustulosis, a skin condition with pustules on the hands and feet. The trial compares this cream applied twice daily with a placebo cream over 16 weeks. It aims to understand if delgocitinib can improve symptoms and quality of life for adults with this condition.

Who may be eligible for this palmoplantar pustulosis clinical trial?

Adults aged 18 years or older with a confirmed diagnosis of mild to severe palmoplantar pustulosis are eligible. Participants must have visible pustules on their palms or soles and have had the condition for more than 6 months. Both men and women can join, but women of childbearing potential must use birth control. Please review eligibility criteria for more details.

Is there any cost to participate in this palmoplantar pustulosis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID07013201

Phase 2a Study to Evaluate Twice Daily Delgocitinib Cream 20 mgg Versus Placebo in Adults With Mild to Severe Palmoplantar Pustulosis Over 16 Weeks

Led by LEO Pharma · Updated on 2026-07-21

135

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of delgocitinib cream 20 mgg applied twice daily compared to a cream vehicle in treating adults with mild to severe palmoplantar pustulosis PPP. This trial is a phase 2a, double-blind study focusing on this skin condition characterized by pustules on the palms and soles. The main goal is to see how well delgocitinib cream improves symptoms over a 16-week treatment period. Participants will be randomly assigned to one of two groups one group will apply delgocitinib cream twice a day for 16 weeks, while the other group will use a matching vehicle cream twice daily for the same duration. The study includes a total of approximately 18 weeks for each participant, involving around 9 visits. The trial compares the active cream to the placebo cream to assess efficacy and safety. During the study, participants will attend scheduled visits to monitor their condition and collect data on skin symptoms, pustule counts, and quality of life measures. Researchers will assess the improvement in PPP severity using specific scales such as the PPP Area and Severity Index PPPASI. Safety is monitored through reports of any treatment-emergent side effects. Overall participation lasts about 18 weeks, including screening and treatment phases.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Signed and dated informed consent obtained before any study procedures.
Age 18 years or older at consent.
Ability to attend clinic visits and follow trial procedures.
Diagnosed with palmoplantar pustulosis (PPP) with pustules on palms and/or soles lasting more than 3 months.
Confirmed PPP by central photograph evaluation.
Mild to severe PPP with disease duration over 6 months.
PPP Physician Global Assessment (PGA) score of at least mild severity (score ≥2) at screening and baseline.
PPP Area and Severity Index (PPPASI) score of 8 or higher at screening and baseline.
At least 5 well-defined fresh pustules on affected areas at screening and baseline.
Prior inadequate response to topical corticosteroids or where corticosteroids are not advised.
Women of childbearing potential must use acceptable birth control during the trial until last study drug administration.

You will not qualify if you...

History or presence of drug-induced PPP.
Presence of acrodermatitis continua of Hallopeau.
Active skin conditions that interfere with PPP diagnosis or study treatment assessment.
Significant infection on palms or soles.
Plaque psoriasis covering more than 5% of body surface area.
Significant infections within 4 weeks before baseline.
Known primary immunodeficiency or positive HIV test.
Major surgery within 8 weeks before screening or planned hospitalization during trial.
Active or suspected malignancy within 5 years except certain skin or cervical cancers.
Unstable disorders affecting safety or ability to complete the trial.
Clinically significant abnormal findings at screening or baseline.
Positive hepatitis B or C infection.
Known allergy to study cream components.
Current or recent substance abuse affecting compliance.
Pregnant or breastfeeding women.
Certain systemic or topical treatments within defined timeframes before baseline.
Participation in other interventional clinical trials or previous randomization in this or delgocitinib trials.
Employees or immediate family of the trial site involved in study conduct.

Research Team

Clinical Disclosure

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Phase 2a Study to Evaluate Twice Daily Delgocitinib Cream 20 mgg Versus Placebo in Adults With Mild to Severe Palmoplantar Pustulosis Over 16 Weeks

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria