LEO Pharma A/S has announced promising results from the Phase 3 DELTA TEEN trial, demonstrating that delgocitinib (Anzupgo) 20 mg/g cream is effective in treating adolescents aged 12 to 17 years with chronic hand eczema (CHE). The cream proved beneficial for those whose condition had not responded adequately to or was deemed inappropriate for topical corticosteroids.
Delgocitinib, a topical pan-Janus kinase (JAK) inhibitor, met all primary and secondary endpoints in the 16-week, randomized, double-blind, parallel-group, multi-site DELTA TEEN study (NCT05355818). This marks the fifth successful Phase 3 trial for delgocitinib, further supporting its potential as a treatment for this condition.
Currently approved for adult use in the European Union, United Kingdom, Switzerland, and the United Arab Emirates, the cream works by inhibiting the JAK-STAT signaling pathway, which plays a key role in the development of CHE, according to LEO Pharma.
The primary endpoint of the DELTA TEEN trial was achieved by the treatment, with success defined as an Investigator’s Global Assessment for Chronic Hand Eczema Treatment Success (IGA-CHE TS) score of 0 (clear) or 1 (almost clear), and at least a two-step improvement from baseline after 16 weeks.
Detailed results from the study are expected to be presented at a scientific meeting and published in a peer-reviewed journal in the near future.
“Chronic hand eczema can significantly impact adolescents, affecting their quality of life, including psychosocial well-being, school performance, and participation in leisure activities,” said Dr. Sonja Molin, an academic dermatologist at Charité Universitätsmedizin Berlin and coordinating investigator of the study. “These findings contribute to a deeper understanding of how moderate to severe CHE affects adolescents and how to best support this underserved group.”
Chronic hand eczema is characterized by persistent symptoms lasting more than three months or recurring twice or more within a year. It affects approximately 4.7% of the population, and many cases progress to become chronic. The condition is marked by symptoms such as itching, pain, erythema, scaling, thickening of the skin, and fissures, particularly on the hands and wrists.
Currently, there are no approved treatments for moderate to severe CHE in adolescents.
The DELTA TEEN study included adolescents diagnosed with CHE that had lasted for more than three months or recurred twice or more within the last year. Participants also had moderate to severe disease, as assessed by IGA-CHE, and had a history of inadequate response to topical corticosteroids (TCS) or were deemed unsuitable for TCS use.
Christophe Bourdon, CEO of LEO Pharma, expressed optimism about the trial results: “The positive results from DELTA TEEN are in line with LEO Pharma’s mission to provide solutions to those suffering from this debilitating condition. With Anzupgo already available to adults in certain markets, it is a crucial step forward in addressing the unmet needs of the adolescent population.”
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