LEO Pharma's phase 3 DELTA TEEN trial has revealed positive results for delgocitinib cream in treating adolescents with moderate to severe chronic hand eczema (CHE). The study, a 16-week, randomized, double-blind, vehicle-controlled trial, assessed the efficacy and safety of twice-daily application of delgocitinib 20 mg/g cream in patients aged 12 to 17 years for whom topical corticosteroids were either inadequate or not advisable.
The DELTA TEEN trial met its primary endpoint, demonstrating a statistically significant improvement in CHE symptoms compared to the cream vehicle after 16 weeks. The primary endpoint was defined as the Investigator’s Global Assessment for Chronic Hand Eczema treatment success (IGA-CHE TS) at Week 16, with treatment success defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline.
Unmet Needs in Adolescent CHE Treatment
Currently, there are no approved therapies specifically indicated for moderate to severe CHE in the adolescent population. This lack of treatment options can significantly affect the quality of life for young patients. CHE, characterized by itch, pain, erythema, scaling, and fissures on the hands and wrists, can lead to psychosocial challenges, impact school performance, and limit leisure activities.
"Research on adolescents with CHE has revealed that the condition can considerably affect their quality of life, including psychosocial well-being, school performance and leisure activities," said Sonja Molin, MD, academic dermatologist at Charite Universitätsmedizin Berlin, adjunct associate professor of dermatology at Queen’s University, and coordinating investigator.
Delgocitinib: A Potential New Option
Delgocitinib is a topical pan-Janus kinase (JAK) inhibitor that inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE. By blocking this pathway, delgocitinib aims to reduce dermal inflammation, restore skin barrier function, and normalize alterations of the skin microbiome.
Clinical Implications and Future Directions
The positive results from the DELTA TEEN trial suggest that delgocitinib could offer a valuable addition to the treatment options for CHE in adolescents. The safety profile of delgocitinib in the trial was consistent with that of previous pivotal trials. LEO Pharma plans to submit detailed results from DELTA TEEN for scientific presentation and publication at a later date.
"The positive results from DELTA TEEN are encouraging and in line with LEO Pharma’s purpose of serving more and more people living with this debilitating condition," said Christophe Bourdon, CEO of LEO Pharma. "[Delgocitinib] is already available to adults in some markets, including Germany, and it is a critical next step to address the unmet need in this younger patient population."
CHE: A Chronic and Debilitating Condition
Chronic Hand Eczema (CHE) is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year. It is one of the most common skin disorders of the hands, with a prevalence rate of approximately 4.7%. CHE can cause significant psychological and functional burdens, impacting patient quality of life and potentially affecting careers and earning potential.
