BALLERUP, Denmark– LEO Pharma A/S, a global leader in medical dermatology, today announced positive results of the DELTA 2 trial. DELTA 2 is the second of two pivotal phase 3 clinical trials with delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, for the potential treatment of adults with moderate to severe chronic hand eczema (CHE).
The trial met its primary endpoint with a statistically significant improvement in CHE after 16 weeks of treatment with delgocitinib cream compared to cream vehicle, and the treatment was well-tolerated. All or most of the signs and symptoms of CHE were cleared early in the treatment period for a significantly larger proportion of patients treated with delgocitinib cream compared to subjects treated with cream vehicle. DELTA 2 is the second phase 3 trial to achieve its primary and all key secondary endpoints, confirming the positive results of the DELTA 1 trial.
“It is incredibly exciting to see the level of consistency that our DELTA 2 results show in line with the positive DELTA 1 results announced late last year”, said Jörg Möller, Executive Vice President, Global Research & Development, LEO Pharma. “CHE is a condition that we know can have a hugely negative impact on patient quality of life, physical functioning, and ability to work. These results bring us one step closer towards establishing delgocitinib as a best-in-class innovative topical treatment for patients affected by this hard-to-treat disease.”
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 to evaluate the long-term effects of delgocitinib cream.2
Further analyses of the data set will be conducted to determine the full potential of delgocitinib cream in the treatment of adults with moderate to severe CHE. Detailed results from DELTA 2 are planned to be submitted for scientific presentation and publication at a later date.
