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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Palmoplantar Pustulosis

Interventions

Type	Name	Description
DRUG	Delgocitinib cream	Topical application
DRUG	Vehicle cream	Topical application

Timeline

• Start date: 2025-09-11
• Primary completion: 2026-12-14
• Completion: 2026-12-14
• First posted: 2025-06-10
• Last updated: 2026-03-16

Locations

36 sites across 5 countries: United States, Canada, Germany, Poland, United Kingdom

Regulatory

• FDA-regulated drug study