Denmark-based LEO Pharma A/S has announced the commencement of a China Phase III clinical study with the enrollment and dosing of the first patient for its delgocitinib cream, marking the first clinical study for the product in China. This milestone signifies the company’s efforts to address moderate to severe adult chronic hand eczema with a novel treatment option.
Delgocitinib: A Novel Treatment for Chronic Inflammatory Skin Disease
Delgocitinib is a first-in-class investigational pan-JAK inhibitor designed for external use. It functions by inhibiting the activation of the JAK-STAT signaling pathway, which is implicated in the development of chronic inflammatory skin diseases. This pathway is pivotal from a pathophysiological standpoint and plays a significant role in the immune system’s response.
Phase III Study Design and Expectations
The Phase III study aims to assess the efficacy, safety, and pharmacokinetics of delgocitinib cream in patients with moderate to severe chronic hand eczema. The trial is expected to enroll 360 patients across 37 centers in China, providing a robust dataset to evaluate the potential benefits of the treatment. The study’s outcomes could significantly contribute to the treatment landscape for chronic hand eczema, a condition that affects many adults and significantly impacts their quality of life.-Fineline Info & Tech
