Chronic hand eczema can have a significant negative impact on quality of life.
Leo Pharma announced the recent positive phase 3 data from the DELTA 2 (NCT04872101) trial investigating the safety and efficacy of delgocitinib cream for the treatment of moderate-to-severe chronic hand eczema (CHE) in adults. DELTA 2 met all of its primary and key secondary endpoints. Positive results from DELTA 2, the second phase 3 trial of delgocitinib, further confirm the reported positive phase 3 results of the first DELTA 1 trial (NCT04871711).
The primary endpoint of DELTA 2 is a statistically significant improvement in CHE after 16 weeks of treatment with delgocitinib cream compared to placebo, with a good tolerability profile. All or most of the symptoms of CHE were cleared early in the treatment period for a large percentage of patients treated with delgocitinib cream compared to participants treated with the placebo.
The primary endpoint of the DELTA 1 and DELTA 2 trials is the Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at week 16. CHE 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).
The 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, at least 75% improvement from baseline, and at least 90% improvement from baseline on the Hand Eczema Severity Index (HECSI) at week 16. The key safety endpoints of the trials are determined by the number of treatment-emergent adverse events from baseline to week 16.
Participants who completed 16 weeks of treatment with delgocitinib cream or placebo applied twice daily in clinical trials DELTA 1 or DELTA 2 were offered to participate in the DELTA 3 extension trial. The goal of the extension trial is to evaluate the long-term effects of delgocitinib.
Delgocitinib is an investigational topical pan-Janus kinase (JAK)- inhibitor that inhibits the activation of the JAK-STAT pathway, responsible for the pathophysiology of chronic inflammatory diseases. Patients with CHE frequently experienced erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on the hands and wrists.