Phase III DELTA 1 trial of delgocitinib cream shows improvements in primary and key secondary endpoints for severe chronic hand eczema with data presented at American Academy of Dermatology 2023 Annual Meeting.- LEO Pharma

The safety and efficacy of delgocitinib cream is under investigation and has not been evaluated by any health authority.

The DELTA 1 trial randomized 487 adults with moderate-to-severe CHE to twice-daily delgocitinib cream 20 mg/g (n=325) or cream vehicle (n=162) for 16 weeks followed by a 36-week extension trial. The primary endpoint was the proportion of patients with moderate to severe CHE who achieved an Investigator’s Global Assessment (IGA)-CHE score of 0 (clear) or 1 (almost clear: barely perceptible erythema only) with an at least 2 point improvement from baseline at Week 16. A significantly greater proportion of delgocitinib-treated patients, compared to cream vehicle, achieved this IGA-CHE improvement (19.7% vs. 9.9%; p=0.006). Similar differences were observed at Week 4 (15.4% vs. 4.9%; p<0.001) and week 8 (22.8% vs. 10.5%; p="0.001)."></0.001)>

The trial also achieved its key secondary endpoints at Week 16. A significantly greater proportion of delgocitinib-treated patients achieved an at least 75% improvement in Hand Eczema Severity Index (HECSI-75) compared to cream vehicle (49.2% vs. 23.5%; p<0.001). a similar trend was observed in those achieving an at least 90% improvement (hecsi-90) (29.5% vs. 12.3%; p><0.001). the dermatology life quality index (dlqi) was another key secondary endpoint used to measure patient-reported efficacy. an at least 4-point improvement was observed in 74.4% of delgocitinib-treated patients compared to 50.0% for cream vehicle (p><0.001).></0.001).></0.001).></0.001).>

Over the 16-week trial period, no difference was observed between delgocitinib and cream vehicle in the proportion of patients who presented adverse events (AEs) and serious AEs. Rates of AEs, AEs probably or possibly related to study drug or AEs leading to discontinuation of study drug were numerically higher with cream vehicle compared to delgocitinib from baseline to trial completion (delgocitinib 45.2% vs. cream vehicle 50.6%, 3.7% vs. 8.0% and 0.6% vs. 3.7%, respectively). The most common AEs (at least 5% in any treatment group) during the study were COVID-19 infections and nasopharyngitis and rates were comparable between the treatment arms. Subjects who completed 16 weeks of treatment in trials DELTA 1 or DELTA 2 were offered to roll-over to the DELTA 3 extension trial evaluate the long-term safety and efficacy of an as-needed treatment with twice-daily applications of delgocitinib cream. Data were presented in one of two LEO Pharma late-breaking sessions at the American Academy of Dermatology (AAD) 2023 Annual Meeting.