The 16-week study by Leo Pharma assessed the efficacy of the cream in adults.
Leo Pharma released results of the DELTA 1 pivotal phase 3 clinical trial of delgocitinib cream for the treatment of moderate to severe chronic hand eczema (CHE).1
The 16-week study in adult participants followed them as they regularly visited the study doctor to assess their CHE and to answer questions about itch, pain, symptoms, and quality of life.
The randomized, double-blind, vehicle-controlled, multicenter trial included 487 participants with moderate to severe CHE. Patients were treated with twice daily delgocitinib cream 20 mg/g compared to cream vehicle. Delgocitinib cream met the study’s primary endpoint by significantly improving CHE after 16 weeks of treatment.
The primary endpoint of the trials is the Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at Week 16. Treatment success is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear, with little or no disease left) with at least a two-step improvement from baseline. Additional IGA-CHE scores include 2 (mild), 3 (moderate) and 4 (severe).
Key secondary endpoints at Week 16 include reduction of itch and pain scores of ≥4 points measured by the Hand Eczema Symptom Diary (HESD) from baseline to Week 16, as well as at least 75% improvement from baseline and at least 90% improvement from baseline on the Hand Eczema Severity Index (HECSI) at Week 16. The number of treatment-emergent adverse events from baseline to Week 16 defines the key safety endpoint of the trials.
Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor and works by blocking activation of the JAK-STAT pathway, which is a known contributor to the pathophysiology of chronic inflammatory diseases. The cream is the only treatment in the United States in development specifically for CHE, which is
described as hand eczema lasting more than 3 months or relapsing twice or more within a year. CHE can cause swelling, itching, blisters, and severe pain. Detailed results from DELTA 1 are planned to be submitted for scientific presentation and publication at a later date. In addition to the DELTA 1 trial, delgocitinib cream is also being investigated in the second pivotal trial DELTA 2, which is still ongoing.
Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1). Updated Nov. 2, 2022. Accessed Dec. 20, 2022. https://clinicaltrials.gov/ct2/show/NCT04871711.