Phase 3 clinical trial focuses on adults with moderate-to-severe chronic hand eczema.
LEO Pharma has announced positive results from its DELTA 1 trial – the first of two pivotal phases 3 clinical trials involving delgocitinib cream.
The treatment is an investigational topical pan-Janus kinase (JAK)-inhibitor for 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, and the treatment was generally well-tolerated. Furthermore, all or most of the symptoms of CHE were cleared early in the treatment period in a significantly larger proportion of subjects treated with delgocitinib cream compared to control subjects.
Further analysis of the data set will be conducted to determine the full potential of delgocitinib cream, while detailed results from DELTA 1 are planned to be submitted for scientific presentation and publication at a later date. Meanwhile, the cream is also being investigated in the second pivotal trial – DELTA 2 – which is ongoing.
Jörg Möller, executive vice president, of global research and development at LEO Pharma, reflected: “In its moderate to severe form, CHE can cause unbearable recurring symptoms, which negatively impact the quality of life, physical functioning and ability to work. There are currently no topical treatments specifically developed and approved for the treatment of moderate-to-severe CHE, making it a challenging disease to treat.”
“We are encouraged by these top-line phase 3 trial results, which show that delgocitinib cream provided fast symptom relief and could be an efficacious and well-tolerated treatment solution, helping adults suffering from moderate to severe CHE to regain their social and occupational lives,” he added.
CHE is defined as hand eczema that lasts for more than three months or relapses twice or more within a year. The condition is the most common skin disorder of the hand, affecting an estimated 1-5% of the general population.