LEO Pharma Publishes Chronic Hand Eczema Phase 3 Data in The Lancet

LEO Pharma A/S, a global authority in medical dermatology, has announced that the results from its DELTA 1 and DELTA 2 phase 3 clinical trials for delgocitinib cream have been published in The Lancet. This marks the first time The Lancet has featured data on an investigational topical pan-Janus kinase (JAK) inhibitor aimed at treating moderate to severe chronic hand eczema (CHE).

The DELTA 1 and DELTA 2 trials were randomized, double-blind, multi-center, vehicle-controlled studies that assessed the safety and efficacy of delgocitinib cream versus a cream vehicle. The trials targeted adult patients with moderate to severe CHE who had inadequate responses to topical corticosteroids or for whom corticosteroids were not advisable.

Kreesten Meldgaard Madsen, LEO Pharma’s Chief Development Officer, highlighted the importance of having the trial results showcased in such a prestigious medical journal. He noted that it signifies a vital step in their mission to raise awareness and develop new treatment options for individuals living with CHE. He expressed pride in the milestone and commended the efforts of everyone involved in the trials.

Dr. Robert Bissonnette, the lead author and MD from Innovaderm Research in Montreal, also praised the publication, noting that CHE has historically been under-researched. He emphasized that the findings of the DELTA 1 and DELTA 2 trials in The Lancet could help spotlight the condition and foster further research, ultimately improving the lives of those affected by CHE.

The primary and secondary endpoints were successfully met in both DELTA 1 and DELTA 2 trials. The primary objective was to evaluate the safety and efficacy of twice-daily applications of delgocitinib cream compared to a cream vehicle. The primary endpoint was defined as the Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at Week 16, indicating a score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from the baseline.

Key secondary endpoints included a significant reduction in itch and pain scores, measured by the Hand Eczema Symptom Diary (HESD) from baseline to Week 16. Additional metrics included at least 75% and 90% improvement on the Hand Eczema Severity Index (HECSI) at Week 16. The trials also monitored treatment-emergent adverse events from baseline to the 16-week mark.

Participants who completed the initial 16 weeks of treatment with delgocitinib cream or the cream vehicle were given the option to enroll in the DELTA 3 open-label, multi-site 36-week extension trial. The extension aimed to evaluate the long-term safety of delgocitinib.

Chronic hand eczema (CHE) is a persistent condition characterized by skin inflammation, itchiness, and pain. It can cause symptoms such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures. CHE significantly affects patients' quality of life, with about 70% of individuals experiencing disruptions in daily activities and professional life.

Delgocitinib cream, an investigational topical pan-Janus kinase (JAK) inhibitor, works by inhibiting the activation of JAK-STAT signaling, a key pathway in CHE pathogenesis. LEO Pharma is working on developing this cream for treating moderate to severe CHE in adults. Under a 2014 license agreement with Japan Tobacco Inc. (JT), LEO Pharma has the exclusive rights to develop and commercialize delgocitinib globally, except in Japan.

LEO Pharma, founded in 1908 and headquartered in Denmark, is dedicated to improving care standards for people with skin conditions. The company, majority-owned by the LEO Foundation, has a long history of dermatological research and development and offers a wide range of therapies. In 2023, LEO Pharma reported net sales of DKK 11.4 billion.