Phase III DELTA 1 trial of Corectim 0.5% ointment meets primary endpoint in chronic hand eczema
LEO Pharma announced positive results of the DELTA 1 trial
DELTA 1 is the first of two pivotal phase III clinical trials with Corectim 0.5% ointment (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 compared to vehicle and the treatment was generally well-tolerated. All or most of the signs and symptoms of CHE were cleared early in the treatment period in a significantly larger proportion of subjects treated with delgocitinib cream compared to subjects treated with vehicle.
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 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.