
LEO Pharma Reports Positive DELTA TEEN Results for Anzupgo® in Adolescent CHE
LEO Pharma Reports A/S, a global leader in medical dermatology, has announced the successful completion of its DELTA TEEN trial, a pivotal phase 3 clinical study evaluating Anzupgo® (delgocitinib) 20mg/g cream. This topical pan-Janus kinase (JAK) inhibitor has been developed as a potential treatment for adolescents (aged 12-17) suffering from moderate to severe Chronic Hand Eczema (CHE), particularly those for whom topical corticosteroids are either inadequate or inappropriate.
The DELTA TEEN Pharma Reports trial marks a significant milestone in dermatological research, being the fifth phase 3 trial in the DELTA program to achieve both its primary and key secondary endpoints. These results validate the findings of previous clinical trials and further expand LEO Pharma’s growing portfolio of evidence supporting the use of Anzupgo® for patients with moderate to severe CHE. The success of DELTA TEEN provides critical insights into a previously underserved patient population, offering potential new treatment options for adolescents affected by this debilitating condition.
The Burden of Chronic Hand Eczema in Adolescents

Pharma Reports Chronic Hand Eczema (CHE) is a long-term inflammatory skin disease characterized by persistent redness, scaling, dryness, cracks, and painful fissures on the hands. It can severely impact daily life, affecting basic functions such as writing, using electronic devices, and engaging in recreational activities. For adolescents, the burden of CHE extends beyond physical discomfort, often impacting their psychosocial well-being, self-esteem, and academic performance.
Currently, Pharma Reports no treatments are specifically approved for the management of moderate to severe CHE in adolescent patients. Most treatment options, including topical corticosteroids, present limitations due to potential side effects and inconsistent efficacy. The lack of targeted therapies highlights an unmet medical need, making the results of the DELTA TEEN trial particularly significant for healthcare providers and patients alike.
Study Design and Methodology
The Pharma Reports DELTA TEEN trial was designed as a randomized, double-blind, vehicle-controlled study to assess the efficacy and safety of Anzupgo® 20mg/g cream in adolescents with moderate to severe CHE. Patients were randomly assigned to receive either Anzupgo® or a placebo (cream vehicle) over a treatment period of 16 weeks. The trial’s primary endpoint focused on a statistically significant improvement in CHE symptoms, measured using validated dermatological assessment tools.
In addition to the primary endpoint, the study evaluated several key secondary endpoints, including:
- Reduction in lesion severity
- Improvement in pruritus (itching) levels
- Overall patient-reported quality of life outcomes
- Safety and tolerability of Anzupgo® in adolescent patients
Key Findings from DELTA TEEN
The Pharma Reports trial successfully met its primary endpoint, demonstrating a statistically significant improvement in CHE symptoms after 16 weeks of treatment Pharma Reports with Anzupgo® compared to the placebo. The efficacy data from DELTA TEEN is consistent with previous pivotal trials in the DELTA program, reinforcing the therapeutic potential of Anzupgo® across different patient demographics.
Further analysis revealed that:
- Patients treated with Anzupgo® exhibited a meaningful reduction in inflammation and lesion severity.
- A significant decrease in pruritus levels was observed, contributing to improved comfort and reduced disruption in daily activities.
- Quality of life scores improved considerably among patients receiving Anzupgo®, indicating broader benefits beyond symptom control.
Safety and Tolerability
One of the critical aspects of the DELTA TEEN trial was the evaluation of Pharma Reports Anzupgo®’s safety profile. Findings confirmed that the treatment was well-tolerated, with a safety profile consistent with that observed in previous clinical trials involving adult patients. No unexpected adverse events were reported, and the most common side effects were mild and transient in nature.
Expert Insights
Pharma Reports Professor Sonja Molin, an academic dermatologist at Charité Universitätsmedizin Berlin and Adjunct Associate Professor of Dermatology at Queen’s University, served as a coordinating investigator in the study. She emphasized the significance of these findings:
“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. These findings further our understanding of how moderate to severe CHE manifests in adolescents and how to support this underserved patient group.”
Professor Molin’s remarks underscore the importance of developing targeted therapies for adolescent patients, a demographic often overlooked in dermatological research.
Implications for the Future
The positive results from the DELTA TEEN trial represent a major step forward for LEO Pharma in its mission to provide innovative solutions for dermatological conditions. Christophe Bourdon, Chief Executive Officer of LEO Pharma, commented on the significance of the trial outcomes:
“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. 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.”
Currently, Anzupgo® has received regulatory approval for adult patients in the European Union, United Kingdom, Switzerland, and the United Arab Emirates for the treatment of moderate to severe CHE. With the success of the DELTA TEEN trial, LEO Pharma is now positioned to seek regulatory approval for adolescent patients, expanding treatment access to a broader population.
Future Plans and Regulatory Pathway
Given the compelling data from the DELTA TEEN trial, LEO Pharma intends to submit these findings for scientific presentation and publication. Additionally, the company plans to engage with regulatory authorities in key global markets, including the United States, to pursue expanded indications for Anzupgo® in adolescents.
The path to regulatory approval will likely involve:
- Submission of DELTA TEEN trial data to the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA)
- Potential advisory committee meetings to discuss the implications of the study findings
- Ongoing post-market surveillance to monitor long-term safety and efficacy