Delgocitinib Effective for Chronic Hand Eczema in Teens in Pivotal Phase 3 Findings

Sonja Molin, MD

Credit: Queen's University

Positive phase 3 findings have been announced by LEO Pharma regarding delgocitinib (Anzupgo) 20mg/g cream for treatment of chronic hand eczema (CHE) among adolescents aged 12-17 years.^1,2

The February 4 announcement followed the pivotal DELTA TEEN trial, during which investigators evaluated this topical pan-Janus kinase (JAK) inhibitor for teenage patients. Delgocitinib is specifically being assessed for moderate-to-severe CHE in patients of this age range who have not responded adequately to or cannot implement topical corticosteroids.

"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, a professor and academic dermatologist at Charite Universitätsmedizin Berlin and coordinating investigator, said in a statement. "These findings further our understanding of how moderate to severe CHE manifests in adolescents and how to support this underserved patient group."¹

The announcement highlighted that there has yet to be an approved therapy option specifically indicated for adolescents with moderate-to-severe CHE. The condition itself 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.

It is also the most prevalent skin disorder impacting the hands and can often result in symptoms such as pain, pruritus, erythema, lichenification, scaling, vesicles, hyperkeratosis, edema, and fissures. Delgocitinib is a topical JAK inhibitor that works by targeting the JAK-STAT signaling pathway, a pathway known to be a key driver of CHE pathogenesis.

To assess this drug’s impact on CHE among teens with moderate-to-severe disease, investigators conducted the 16-week, phase 3 DELTA TEEN trial using a randomized, double-blind, vehicle-controlled, parallel-group, multi-site design. They looked at the medication’s efficacy and safety with twice-daily use, determining the primary endpoint to be Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at the 16-week mark.²

IGA-CGE TS was specifically defined as achievement of a score of 0 (clear) or 1 (almost clear) with at least a 2-step improvement from the point of baseline. The drug’s performance was compared to study participants using the cream vehicle (P < .05).²

By the 16-week mark, the DELTA TEEN team reported that the trial met both primary and all key secondary endpoints, marking the fifth phase 3 clinical trial in which delgocitinib did so. Delgocitinib’s safety profile was also consistent with prior pivotal studies on the drug.

The announcement noted that additional result details from DELTA TEEN are expected to be presented during future scientific conferences and published in peer-reviewed journals. The drug has, thus far, been approved within the European Union, Switzerland, the United Kingdom, and the United Arab Emirates for the treatment of moderate to severe CHE in adults who cannot use or do not respond to topical corticosteroids.

“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 a 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

References

1. ^{LEO Pharma Achieves Positive DELTA TEEN Trial Results with Anzupgo® (delgocitinib) Cream in Adolescents with Moderate to Severe Chronic Hand Eczema (CHE). LEO Pharma. February 4, 2025. https://www.businesswire.com/news/home/20250204233015/en/LEO-Pharma-Achieves-Positive-DELTA-TEEN-Trial-Results-with-Anzupgo%C2%AE-delgocitinib-Cream-in-Adolescents-with-Moderate-to-Severe-Chronic-Hand-Eczema-CHE.}
2. ^{Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN). ClinicalTrials.gov. National Library of Medicine (U.S.). Identifier: NCT05355818. https://clinicaltrials.gov/study/NCT05355818. Date accessed: February 4, 2025.}