Delgocitinib Could Close Gap in Adolescent CHE Treatment

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Adolescents with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids prove inadequate or inappropriate, have historically faced limited treatment options. LEO Pharma's recent DELTA TEEN phase 3 clinical trial assessed the efficacy and safety of delgocitinib (Anzupgo) cream, a pan-Janus kinase (JAK) inhibitor, in this demographic.¹

"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 Professor Sonja Molin, academic dermatologist at Charite Universitätsmedizin Berlin and adjunct associate professor of dermatology at Queen’s University and coordinating investigator, in a news release. "These findings further our understanding of how moderate to severe CHE manifests in adolescents and how to support this underserved patient group."

Study Overview

According to the release from the company, DELTA TEEN was a 16-week, randomized, double-blind, vehicle-controlled, parallel-group trial designed to evaluate delgocitinib’s effectiveness in adolescents aged 12 to 17. The trial aimed to determine treatment success using the Investigator’s Global Assessment for CHE Treatment Success (IGA-CHE TS) at week 16. Treatment success was defined as achieving an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a 2-step improvement from baseline.

Key Findings

The trial successfully met its primary and all key secondary endpoints, demonstrating statistically significant improvements in CHE symptoms after 16 weeks of delgocitinib treatment compared to the cream vehicle. Moreover, researchers stated the safety profile of delgocitinib remained consistent with prior trials, further reinforcing its potential as a therapeutic option for adolescents with moderate to severe CHE.

Clinical Significance

Adolescents with CHE often experience significant quality-of-life impairments, including disruptions in educational performance, social interactions, and daily activities.² LEO Pharma noted the absence of approved treatments for this age group has left an unmet clinical need. The findings from DELTA TEEN offer promising evidence supporting the use of delgocitinib in addressing this treatment gap.

Mechanism of Action

Delgocitinib functions as a topical pan-JAK inhibitor, which modulates the JAK-STAT signaling pathway—a key driver of CHE pathogenesis. By inhibiting this pathway, the drug aims to alleviate inflammation, restore skin barrier function, and improve overall symptomatology. The trial results align with previous DELTA program studies that have consistently validated delgocitinib’s efficacy and safety profile.

Regulatory Status and Future Prospects

Delgocitinib is currently approved for adult patients with moderate to severe CHE 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, with planned submissions for scientific presentations and regulatory approvals.

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, chief executive officer, LEO Pharma, in the release. “[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.”

Conclusion

The DELTA TEEN trial marks a significant step in the management of adolescent CHE, providing robust evidence for delgocitinib’s efficacy and safety. Given the substantial burden of CHE on adolescent patients, the potential approval of delgocitinib for this age group could fill a critical treatment void. The company stated further research and regulatory review will determine the broader clinical implications of these findings.

References

1. TEEN trial results with anzupgo ® (delgocitinib) cream in adolescents with moderate to severe chronic hand eczema (CHE). News release. LEO Pharma. Published February 4, 2025. Accessed February 4, 2025. https://www.leo-pharma.com/media-center/news/2025-delta-teen-topline-key-results
2. Haft MA, Park HH, Lee SS, et al. Pediatric chronic hand eczema: Epidemiology, clinical presentation, and management. JAAD Int. 2023;11:165-173.