Positive phase 3 results reported for delgocitinib cream for chronic hand eczema

Delgocitinib cream met the primary endpoint in the DELTA 1 pivotal phase 3 clinical trial for the treatment of moderate to severe chronic hand eczema in adults, according to a press release from Leo Pharma.

The randomized, double-blind, vehicle-controlled, multicenter trial included 487 participants with moderate to severe chronic hand eczema (CHE). Delgocitinib cream, an investigational topical pan-Janus kinase inhibitor, met the study’s primary endpoint by significantly improving CHE after 16 weeks of treatment compared with vehicle. Early in the treatment period, all or most of the CHE signs and symptoms were cleared in a significantly larger proportion of those treated with delgocitinib cream compared with vehicle.

The majority of adverse events were nonserious, mild or moderate and not related to the treatment, the release said.

“In its moderate to severe form, CHE can cause unbearable recurring symptoms, which negatively impact quality of life, physical functioning and ability to work,” Jörg Möller, executive vice president of global research and development at Leo Pharma, said in the release. “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.”

Delgocitinib cream for CHE is also being investigated in the ongoing DELTA 2 trial, a second pivotal trial. Analysis of the DELTA 1 data will continue.

Reference:

• Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1). https://clinicaltrials.gov/ct2/show/NCT04871711. Updated Nov. 2, 2022. Accessed Dec. 14, 2022.