LEO shares positive results for delgocitinib cream in head-to-head chronic hand eczema study
24 Jan 2024
Clinical ResultDrug ApprovalPhase 3
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Source: PMLiVE
LEO Pharma has announced positive results from a head-to-head study of its investigational JAK-inhibitorJAK-inhibitor cream, delgocitinib, in adults with severe chronic hand eczema (CHE).
Hand eczema is the most common skin disorder of the hands and one of the most common types of eczema.
In patients with hand eczema, the skin is generally dry, scaly and thickened, and the fingers can become swollen when the eczema is flaring. Other symptoms may include cracking, soreness, bleeding and, in some cases, blisters.
CHE, which affects a substantial number of patients, is defined as hand eczema that lasts for more than three months or relapses twice or more within a year.
Alitretinoin is currently the only treatment specifically approved to treat severe CHE in patients who do not respond to topical corticosteroids.
The late-stage DELTA FORCE study has been comparing the efficacy and safety of twice-daily delgocitinib cream with once-daily alitretinoin capsules.
The primary endpoint of the trial was met with delgocitinib cream demonstrating a superior reduction in Hand Eczema Severity Index (HECSI) score from baseline to week 12 compared to alitretinoin capsules.
The candidate also demonstrated superiority to alitretinoin capsules in all key secondary outcome measures, including Investigator’s Global Assessment-CHE treatment success, a reduction in HECSI score from baseline to week 24, and a significant improvement in health-related quality of life.
Additionally, patients receiving delgocitinib cream experienced a lower number of treatment-emergent adverse events compared to those receiving alitretinoin capsules, and no specific treatment-emergent safety concerns were identified for the candidate.
Further data analyses will be conducted to determine any “additional potential” of delgocitinib cream in the treatment of adults with moderate-to-severe CHE, LEO said, adding that detailed results from the trial are planned to be submitted for scientific presentation and publication “at a later date”.
Kreesten Meldgaard Madsen, chief development officer at LEO, said: “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.”
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