Delgocitinib cream significantly improved chronic hand eczema in adult patients, according to topline results from the DELTA 1 study.

The phase 3 study (ClinicalTrials.gov Identifier: NCT04871711) compared delgocitinib cream, a topical pan-Janus kinase (JAK) inhibitor, to vehicle in patients with moderate to severe chronic hand eczema. The primary endpoint was the Investigator’s Global Assessment for chronic hand eczema (IGA-CHE) treatment success at week 16. Treatment success was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear, with little or no disease left) with at least a 2-step improvement from baseline.

Findings showed that the trial met its primary endpoint with a significantly larger proportion of delgocitinib-treated patients achieving treatment success compared with the vehicle arm. The study also met key secondary endpoints including a reduction of itch and pain scores of at least 4 points (as measured by the Hand Eczema Symptom Diary), as well as at least 75% improvement from baseline and at least 90% improvement from baseline on the Hand Eczema Severity Index at week 16.

“There are currently no topical treatments specifically developed and approved for the treatment of moderate to severe [chronic hand eczema], making it a challenging disease to treat,” said Jörg Möller, Executive Vice President, Global Research & Development, LEO Pharma. “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 [chronic hand eczema] to regain their social and occupational lives.”

Delgocitinib cream is also being evaluated for chronic hand eczema in the ongoing phase 3 DELTA 2 study (ClinicalTrials.gov Identifier: NCT04872101).

Reference

LEO Pharma announces positive phase 3 topline results from DELTA 1 trial with delgocitinib cream in adults with moderate to severe chronic hand eczema (CHE). News release. December 6, 2022. https://www.businesswire.com/news/home/20221205005373/en/LEO-Pharma-Announces-Positive-Phase-3-Topline-Results-From-DELTA-1-Trial-With-Delgocitinib-Cream-in-Adults-With-Moderate-to-Severe-Chronic-Hand-Eczema-CHE.