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

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

NCT07013201

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

Led by LEO Pharma · Updated on 2026-03-16

135

Participants Needed

Research Sites

65 weeks

Total Duration

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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 before any study procedures
Age 18 years or older at consent signing
Able to comply with clinic visits and study procedures
Diagnosis of palmoplantar pustulosis (PPP) with primary, persistent (over 3 months) sterile pustules on palms and/or soles
Confirmed PPP by central photographic evaluation at screening
Mild to severe PPP with disease duration over 6 months
PPP Physician Global Assessment (PPP-PGA) score of 2 or more at screening and baseline
PPP Area and Severity Index (PPPASI) score of 8 or more at screening and baseline
Presence of 5 or more well-demarcated fresh pustules on all affected areas at screening and baseline
Prior inadequate response to topical corticosteroids or corticosteroids inadvisable as judged by investigator
Women of childbearing potential must use acceptable birth control throughout the trial until last study drug administration

You will not qualify if you...

Presence or history of drug-induced PPP
Presence of acrodermatitis continua of Hallopeau
Active skin conditions that could confuse PPP diagnosis or interfere with study assessments
Clinically significant infection on palms or soles
Plaque psoriasis covering more than 5% of body surface area
Significant infection within 4 weeks prior to baseline that may affect safety or study participation
Known primary immunodeficiency or positive HIV test, or taking antiretroviral medications
Major surgery within 8 weeks before screening or planned hospitalization during study
Active or suspected malignancy within 5 years before screening except certain treated skin or cervical cancers
Any unstable disorder affecting safety or ability to complete the trial
Clinically significant abnormal findings during screening or baseline
Positive hepatitis B surface antigen/core antibody with positive DNA or positive hepatitis C antibody confirmed by RNA
Known or suspected allergy to any study drug components
Current or recent chronic alcohol or drug abuse or poor compliance
Pregnant or lactating women
Systemic immunosuppressive, immunomodulating, retinoid, tyrosine kinase inhibitor, phosphodiesterase-4 inhibitor, or corticosteroid treatment within 4 weeks before baseline (with some allowed inhaled or intranasal steroids)
Use of tanning beds or phototherapy on palms or soles within 4 weeks before baseline
Use of systemic or topical janus kinase inhibitors within 4 weeks before baseline
Topical immunomodulators or corticosteroids on palms or soles within 2 weeks before baseline
Use of systemic or topical antibiotics on palms or soles within 2 weeks before baseline
Use of other topical therapies on palms or soles within 1 week before baseline except non-medicated emollients
Topical treatments on other regions that may interfere with study or pose safety concerns within 1 week before baseline
Treatment with certain biological therapies within specified timeframes before baseline
Treatment with any non-marketed drug within 4 weeks before baseline
Current participation in another interventional clinical trial
Previously randomized in this or a delgocitinib clinical trial
Employment or immediate family relation to trial site staff or involved individuals

AI-Screening