Delgocitinib Effective in Adolescents with CHE in Phase 3 DELTA TEEN Trial
With no FDA-approved treatments for moderate-to-severe chronic hand eczema in the teen population, the late-stage topline data are very promising.
The 16-week DELTA TEEN phase 3 trial of delgocitinib 20mg/g cream (Anzupgo) among adolescents with moderate to severe chronic hand eczema (CHE), met its primary endpoint, demonstrating a statistically significant improvement in CHE symptoms compared with cream vehicle, according to an announcement from LEO Pharma.1
DELTA TEEN Coordinating Investigator
Adjunct Associate Professor of Dermatology at Queen’s University
DELTA TEEN evaluated the safety and efficacy of twice-daily use of delgocitinib compared to placebo, with efficacy measured by the Investigator’s Global Assessment for CHE (IGA-CHE) treatment success at week 16. IGA-CHE treatment success, the primary endpoint, was defined as a score of 0 (clear) or 1 (almost clear) with at least a 2-step improvement from baseline score.1
The safety profile of delgocitinib reported from the randomized, double-blind, vehicle-controlled, parallel-group trial was consistent with that of previous pivotal trials, according to the news release.1
Study participants were aged 12 to 17 years with moderate-to-severe CHE and inadequate response to previous treatment with topical corticosteroids (CTS) or unable to tolerate the medications.2
Delgocitinib is a topical pan-JAK inhibitor, which modulates activation of JAK-STAT signaling, a primary mechanism underlying CHE pathogenesis. Inhibition of the pathway has been shown to reduce dermal inflammation, restore skin barrier function, and normalize alterations of the skin microbiome, LEO Pharma stated.
"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," Sonja Molin, MD, a professor, and academic dermatologist at Charite Universitätsmedizin Berlin and coordinating investigator, said in the LEO Pharma statement. "These findings further our understanding of how moderate-to-severe CHE manifests in adolescents and how to support this underserved patient group."1
Currently there are no approved therapies indicated for treatment of moderate to severe CHE in adolescents. Research shows the median age of the first occurrence of hand eczema in children is aged 12 years but relatively few studies have investigated the disorder in youth.3 Treatment options that are available are limited to those approved for other skin conditions and have no documented effect in CHE or are limited by restrictions to long-term use for safety reasons. There is a high unmet medical need in this young population.3
CHE is a persistent and frequently relapsing inflammatory condition, defined as hand eczema that lasts more than 3 months or recurs at least twice within a given year. Symptoms include pain, pruritus, erythema, lichenification, scaling, edema, and fissures.1
Delgocitinib is currently approved for treatment of moderate to severe CHE in adults who have not responded to or cannot tolerate TCS in the European Union, the United Kingdom, Switzerland, and the United Arab Emirates. The drug remains under investigation in other markets, including the United States. The successful results from DELTA TEEN support its potential expansion into the adolescent population, LEO Pharma stated, and the company plans to present detailed results at future scientific meetings and to submit them for publication in a peer reviewed journal 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,” Christophe Bourdon, LEO Pharma CEO, said in the statement. “[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.”1
