Trial to Investigate Delgocitinib Cream in Adults With Mild to Severe Palmoplantar Pustulosis
Research type
Research Study
Full title
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
IRAS ID
1012118
Contact name
Stephany Micallef
Contact email
Sponsor organisation
LEO Pharma A/S
Eudract number
0000-000000-00
Research summary
Palmoplantar pustulosis (PPP) is an auto-inflammatory disease that causes painful skin lesions to appear on the hands and feet. PPP is a debilitating disease that significantly reduces patient’s quality of life. Currently there are no approved treatments for PPP. There is a need for new, safer and more effective treatments to be developed for the treatment of PPP.
LEO Pharma (the sponsor) are running 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 patients with Mild to Severe PPP. Delgocitinib cream is the study medication being investigated in this research study. The aim of this clinical study is to test the effectiveness and safety of Delgocitinib cream compared to a cream vehicle (dummy cream) in the treatment of patients with PPP.
Participants are expected to be in this study for up to 22 weeks. Study participants will visit the study site at the time points specified in the participant information sheet. Participants will also undergo procedures such as blood and urine pregnancy tests , ECGs, and a physical examination throughout the study . Some participants will have skin biopsies taken (voluntary) and others will have skin tape strips taken (mandatory, selected sites only)
Prior to undergoing any study procedures participants must sign an informed consent form. The research study has 3 periods, the screening period to determine eligibility (up to 4 weeks), Treatment period (16 weeks) and the safety follow-up period (2 weeks).
The treatment will be applied directly on the skin lesions determined by the study doctor. The participant will be informed on how they can apply the treatment at home.
This clinical research study is expected to include 135 participants aged 18 years and above.REC name
East of Scotland Research Ethics Service REC 2
REC reference
25/ES/0053
Date of REC Opinion
5 Aug 2025
REC opinion
Further Information Favourable Opinion