LEO Pharma A/S has announced promising phase 3 results from its DELTA China trial, demonstrating statistically significant improvements in patients aged 12 and older with chronic hand eczema (CHE) treated with delgocitinib (Anzupgo) 20 mg/g cream. These findings, disclosed on February 27, highlight the potential of delgocitinib as a treatment option for individuals with moderate to severe CHE who do not respond to or cannot use topical corticosteroids.
Chronic hand eczema, the most common skin condition affecting the hands, has a prevalence rate of approximately 4.7%. It significantly disrupts daily activities for many patients. Delgocitinib, a topical pan-Janus kinase (JAK) inhibitor, works by targeting the JAK-STAT signaling pathway, which is implicated in the inflammation and skin barrier dysfunction seen in CHE.
Kreesten Meldgaard Madsen, Chief Development Officer at LEO Pharma, emphasized the global importance of the results, stating, “Skin conditions are not specific to borders and nor is our commitment to research. The results from this phase 3 trial in the Chinese population build upon our expanding collection of scientific data for treating moderate to severe CHE globally.”
Delgocitinib cream has already been approved in several countries, including the United Kingdom, European Union, Switzerland, and the United Arab Emirates, for adults with moderate to severe CHE who are unable to use topical corticosteroids. The cream works by inhibiting the JAK-STAT pathway, a critical mechanism in the pathogenesis of CHE, which contributes to inflammation and skin barrier dysfunction.
The DELTA China study, a phase 3 clinical trial, was designed to assess the efficacy, safety, and pharmacokinetics (PK) of delgocitinib cream in Chinese patients with CHE. The trial featured a 16-week double-blind, randomized, vehicle-controlled treatment phase, followed by a 36-week open-label extension.
A total of 362 patients participated, with a 2:1 randomization ratio to receive either delgocitinib or a cream vehicle. The primary endpoint of the trial was the Investigator’s Global Assessment for Chronic Hand Eczema Score (IGA-CHE TS) at 16 weeks. The results revealed significant improvements in the severity of CHE in the delgocitinib group compared to the vehicle group (P < 0.05).
The safety profile of delgocitinib during the 16-week period was consistent with results from previous pivotal trials, and pharmacokinetic data showed low systemic exposure to the drug. The open-label extension phase of the DELTA China trial is ongoing, with further results expected to be shared in future scientific presentations and publications.
These findings are particularly important for the Chinese market, where no medications are currently approved specifically for moderate to severe CHE. LEO Pharma also continues to investigate delgocitinib in other markets, including the United States, as part of its efforts to expand treatment options for CHE.
Byron Yin, General Manager of LEO Pharma in China, commented on the results, stating, “Following the results from DELTA China, including the consistent safety profile and pharmacokinetics data, we will continue our work to investigate delgocitinib cream as a potential treatment option for patients living with moderate to severe CHE, as there are currently no approved treatments specifically for CHE available here in China.”
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