Phase 3: Delgocitinib improves chronic hand eczema in adolescents
The primary and all key secondary endpoints were met compared to cream vehicle in the phase 3 DELTA TEEN trial.
Phase 3: delgocitinib improves chronic hand eczema in adolescents | Image Credit: © kasia2003 - © kasia2003 - stock.adobe.com.
LEO Pharma A/S has reported positive phase 3 data for delgocitinib (Anzupgo) 20 mg /g cream, which has demonstrated efficacy among adolescents aged 12 to 17 years with chronic hand eczema (CHE), for whom topical corticosteroids were inadequate or inappropriate.1
The cream is a topical pan-Janus kinase (JAK) inhibitor, and met the primary and all key secondary endpoints in the phase 3 DELTA TEEN trial (NCT05355818), part of the DELTA clinical trial program. With the data reported, the DELTA TEEN trial is the 5th among delgocitinib phase 3 trials to achieve primary and all key secondary endpoints.
The cream, currently approved in the European Union, United Kingdom, Switzerland, and the United Arab Emirates in adults, inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE, according to LEO Pharma A/S.
In DELTA TEEN, a 16-week, randomized, double-blind, parallel group, and multi-site trial, the primary endpoint was achieved. That endpoint was 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 2-step improvement from baseline.
Specified details from the phase 3 trial are in the works to be submitted for scientific presentation and publication at a later date, stated LEO Pharma A/S in a press release.
"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, academic dermatologist at Charite Universitätsmedizin Berlin, adjunct associate professor of Dermatology at Queen’s University, 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," said Molin.
CHE is HE that lasts for more than 3 months or relapses twice or more within a year. HE, the most common skin disorder of the hands, has a prevalence rate of approximately 4.7%, and can develop into a chronic condition in a "substantial" number of patients, stated LEO Pharma A/S.
The eczema is characterized by itch and pain, with patients experiencing signs like erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.
Currently, no treatment options are approved specifically for moderate to severe CHE in the adolescent population.
According to study details provided by ClinicalTrials.gov, inclusion criteria for the phase 3 DELTA TEEN study were2:
- Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months.
- Disease severity graded as moderate to severe at screening and baseline according to IGA-CHE.
- Subjects who have a documented history of inadequate response to treatment with TCS or for whom TCS are documented to be otherwise medically inadvisable.
"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.1
"Anzupgo 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.”
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 A/S. Press release. February 4, 2025. Accessed 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. Updated January 23, 2025. Accessed February 4, 2025. https://clinicaltrials.gov/study/NCT05355818
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