LEO Pharma Reports Positive Results in Delgocitinib Trial for CHE

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Today, LEO Pharma announced positive primary endpoint results from the double-blind treatment phase of the DELTA China trial. This phase 3 clinical trial evaluates delgocitinib (Anzupgo) 20mg/g cream, a topical pan-Janus kinase (JAK) inhibitor, for its potential to treat moderate to severe Chronic Hand Eczema (CHE) in Chinese adults and adolescents, aged 12 and above, who have not responded adequately to or cannot tolerate topical corticosteroids.¹

Study Design and Methodology

The DELTA China trial was designed as a 16-week randomized, double-blind, vehicle-controlled study, followed by a 36-week open-label treatment period. A total of 362 participants were enrolled and randomly assigned in a 2:1 ratio to receive either delgocitinib or a cream vehicle. The study’s primary endpoint was the Investigator’s Global Assessment for Chronic Hand Eczema Treatment Success (IGA-CHE TS) at week 16, which was met with statistically significant improvements in disease severity for the delgocitinib group compared to the control.²

Key Findings and Clinical Implications

The findings from the double-blind period indicate a meaningful improvement in the severity of CHE among participants treated with delgocitinib. According to a news release from the company, the 16-week safety profile was consistent with previous studies, and pharmacokinetics (PK) data indicated low systemic exposure. The release stated this result aligns with LEO Pharma’s commitment to addressing the needs of patients with moderate to severe CHE, particularly in regions where no specific treatment options are currently approved.

According to Byron Yin, general manager for LEO Pharma in China, in the release, "Following the results from DELTA China, including the consistent safety profile and pharmacokinetics data, we will continue our work to investigate delgocitinib cream as a potential treatment option for patients living with moderate to severe CHE, as there are currently no approved treatments specifically for CHE available here in China. LEO Pharma has a unique heritage for innovative topicals, and I look forward to seeing the full data set, which I hope will set us up for further advances and ultimately help us to introduce this new treatment option in China. "

The study design of DELTA China mirrors the DELTA 1 and 2 phase 3 trials conducted in Europe and Canada, both of which met primary and secondary endpoints.³ Kreesten Meldgaard Madsen, Chief Development Officer at LEO Pharma, emphasized the global nature of this research, stating in the release, "DELTA China demonstrates LEO Pharma’s truly global approach when it comes to addressing the unmet needs of patients living with moderate to severe CHE worldwide. Skin conditions are not specific to borders and nor is our commitment to research. The results from this phase 3 trial in the Chinese population builds upon our expanding collection of scientific data for treating moderate to severe CHE globally. Our work will continue to advance the standard of care for this debilitating condition."

Future Research and Market Implications

The ongoing open-label treatment period, running from week 16 to week 52, will provide additional long-term safety and efficacy data. Results from this phase will be released in the future, potentially paving the way for regulatory approval in China.

Currently, delgocitinib is approved for use in adults in the European Union, United Kingdom, Switzerland, and the United Arab Emirates for the treatment of moderate to severe CHE when corticosteroids are inadequate or inappropriate. It remains under investigation in other markets, including the United States.

The DELTA China trial underscores the importance of expanding treatment options for patients with chronic dermatological conditions. With no approved therapies for moderate to severe CHE in China, the findings from this study may contribute significantly to improving patient outcomes and advancing dermatological care on a global scale. Detailed results from DELTA China are expected to be submitted for scientific publication in the near future.

References

1. LEO pharma meets primary endpoint in phase 3 DELTA China trial with anzupgo® (delgocitinib) cream in Chinese patients with moderate to severe chronic hand eczema (CHE). News release. Leo Pharma. Published Febvruary 27, 2025. Accessed February 27, 2025.https://www.leo-pharma.com/media-center/news/2025-phase-3-delta-china-trial
2. ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy, Safety, and Pharmacokinetics of Delgocitinib Cream in Chinese Adults and Adolescents With Moderate to Severe Chronic Hand Eczema. Identifier: NCT06004050. https://clinicaltrials.gov/study/NCT06004050.
3. Bissonnette R, Warren RB, Pinter A, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet. 2024;404(10451):461-473. doi:10.1016/S0140-6736(24)01027-4.