New Positive Phase 3 Data of Delgocitinib for Chronic Hand Eczema

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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.

Reference

1. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 2). ClinicalTrials.gov Identifier: NCT04872101. Updated January 9, 2023. Accessed February 10, 2023. https://clinicaltrials.gov/ct2/show/NCT04872101?term=DELTA+2&cond=Chronic+Hand+Eczema&draw=2&rank=1