Delgocitinib cream demonstrated a superior reduction in Hand Eczema Severity Index (HECSI) score from baseline to Week 12 compared to alitretinoin capsules in people with severe chronic hand eczema, according to results from the DELTA FORCE Trial, which is the first head-to-head phase 3 trial comparing a systemic and topical treatment for CHE.
Delgocitinib cream also showed superiority to alitretinoin capsules in all key secondary outcome measures, including Investigator’s Global Assessment (IGA)-CHE treatment success, health-related quality of life (HRQoL), and there was a lower number of treatment-emergent adverse events in the Delgocitinib-treated group, the study showed.
DELTA FORCE is a head-to-head trial in adult participants with severe chronic hand eczema (CHE) comparing a potential new topical treatment with a systemic treatment. It is a phase 3, two-arm trial (N=513) that compares the efficacy and safety of delgocitinib cream with alitretinoin capsules.
Alitretinoin is the only treatment currently approved to specifically treat severe CHE in patients who do not respond to topical corticosteroids. Delgocitinib cream is currently under investigation and is not yet approved for use by any health authority.
Delgocitinib cream achieved the primary outcome measure of the trial by demonstrating a superior reduction in Hand Eczema Severity Index (HECSI) score from baseline to Week 12 compared to alitretinoin capsules, the study showed.
Delgocitinib cream also demonstrated superiority to alitretinoin capsules in all key secondary outcome measures, including Investigator’s Global Assessment (IGA)-CHE treatment success, a reduction in HECSI score from baseline to Week 24, and a significant improvement in health-related quality of life (HRQoL), as measured by the Dermatology Life Quality Index (DLQI).
Furthermore, patients receiving delgocitinib cream had a lower number of treatment-emergent adverse events (AEs) compared to those receiving alitretinoin capsules. No specific treatment-emergent safety concerns were identified for delgocitinib cream, and the overall safety profile was consistent with what was observed in DELTA 1, 2 and 3.
“Currently, there is only one specific treatment option available for those living with severe CHE. We are confident that with the DELTA FORCE study, delgocitinib cream may play a crucial role in expanding the options available for patients in this hard-to-treat condition,” says Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma, in a news release.
“Our hands are integral to everything we do. I have heard countless stories from patients about just how much this condition impacts their everyday lives socially, psychologically and physically. CHE often limits their ability to work,” adds Alexander Egeberg, Head of Global Medical Affairs, LEO Pharma. “With such a considerable unmet need for patients living with CHE, we are proud to have conducted this study, which we hope can drive forward a potential new treatment option with delgocitinib cream”.
Further data analyses will be conducted to determine any additional potential of delgocitinib cream in the treatment of adults with moderate to severe CHE.
Detailed results from DELTA FORCE are planned to be submitted for scientific presentation and publication at a later date.
