LEO Pharma has announced positive topline results from its phase 3 trial evaluating the efficacy of delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, as a treatment for adults with moderate-to-severe chronic hand eczema (CHE).
The DELTA 1 trial met its primary endpoint, demonstrating a statistically significant improvement in CHE after 16 weeks of twice-daily applications of delgocitinib cream compared to vehicle.
The company reported that all or most of the signs and symptoms of CHE were cleared early in the treatment period in a ‘significantly larger’ proportion of patients treated with delgocitinib cream compared to those in the vehicle group.
Hand eczema (HE) is the most common skin disorder of the hands that affects an estimated 1-5% of the general population, with a one-year prevalence rate of around 9%. CHE, which affects a substantial number of patients, is defined as HE that lasts for more than three months or relapses twice or more within a year.
CHE is characterised by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.
“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,” said Jörg Möller, executive vice president, global research and development, LEO Pharma.
He added the company was “encouraged by these topline 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 regain their social and occupational lives”.
Data from the trial will be further analysed to determine the full potential of delgocitinib cream, the company said, and plans have already been made to submit detailed results from the study 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.
The trial shares its primary objective with DELTA 1, evaluating the efficacy of twice-daily applications of delgocitinib cream compared with vehicle in the treatment of adults with moderate-to-severe CHE. The primary endpoint of the trials is the Investigator’s Global Assessment for CHE treatment success at week 16.