New Positive Results on Delgocitinib Cream Announced for Chronic Hand Eczema

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New phase 3 findings were released by LEO Pharma A/S in the DELTA China trial, highlighting statistically significant improvements in patients aged 12 years and older with chronic hand eczema (CHE) treated with delgocitinib (Anzupgo) 20 mg/g cream.¹

The February 27 announcement points to the potential of delgocitinib, a topical pan-Janus kinase (JAK) inhibitor, as a potential medication for those with moderate to severe CHE who do not respond adequately to or cannot use topical corticosteroids.¹ CHE, known to be the most common skin disease impacrting the hands, has a prevalence rate of approximately 4.7% and heavily impacts everyday activities among patients.

“Skin conditions are not specific to borders and nor is our commitment to research,” Kreesten Meldgaard Madsen, Chief Development Officer of LEO Pharma, said in a statement. “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.”¹

Delgocitinib cream—approved for adults in the United Kingdom, European Union, Switzerland, and the United Arab Emirates for moderate to severe CHE in individuals for whom topical corticosteroids are not suitable—functions by inhibiting the activation of the JAK-STAT signaling pathway. This pathway plays a significant role in CHE’s pathogenesis, and the disease results in inflammation, skin barrier dysfunction, and shifts in the microbiome.

To evaluate the medication in patients from China with CHE, the DELTA China study was designed as a phase 3 clinical analysis looking at delgocitinib cream’s efficacy, safety, and pharmacokinetics (PK). The trial investigators used a 16-week, double-blind, randomized, vehicle-controlled treatment period, and this was followed by what is still an ongoing 36-week open-label treatment phase.¹

There were 362 individuals involved in the study and randomly assigned in a 2:1 ratio to receive either delgocitinib or a cream vehicle. The DELTA China investigators’ primary goal was to compare the medication’s efficacy with twice-per-day application against the cream vehicle. As a result, it would mirror the structure of the phase 3 DELTA 1 and DELTA 2 studies that were successfully conducted in Europe and Canada.

The newly-announced results cover the first 16 weeks of the double-blind treatment period in DELTA China and represent a significant development in the Chinese market, where no medications are currently approved specifically for those suffering from moderate to severe CHE. The analysis’s primary endpoint, the Investigator’s Global Assessment for Chronic Hand Eczema Score (IGA-CHE TS) at the 16-week mark, was noted by investigators as having been met.

Statistically significant improvements were observed by the investigative team in CHE’s severity for those in the delgocitinib cohort as opposed to those in the vehicle cohort (P < .05). Additionally, the team concluded that delgocitinib’s safety profile over 16 weeks showed consistency with prior pivotal trials.¹ They also found in their pharmacokinetic data that low systemic exposure was observed to the treatment.

The open-label extension of the DELTA China analysis, covering the 16 - 52 week period, continues to this day. Results from this study were noted in the LEO Pharma announcement as intended for future scientific presentations and publications.

Additionally, they highlight that delgocitinib remains under investigation in other markets such as the United States, given the ongoing efforts being conducted to expand the drug’s availability as a therapy option for CHE.²

“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,” Byron Yin, General Manager for LEO Pharma in China, said in a statement.¹

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). LEO Pharma A/S. February 27, 2025. https://www.businesswire.com/news/home/20250227098010/en/LEO-Pharma-Meets-Primary-Endpoint-in-Phase-3-DELTA-China-Trial-with-Anzupgo%C2%AE-delgocitinib-Cream-in-Chinese-Patients-with-Moderate-to-Severe-Chronic-Hand-Eczema-CHE.

2. FDA Accepts LEO Pharma’s Filing of Delgocitinib Cream New Drug Application for the Treatment of Chronic Hand Eczema. Leo Pharma. September 23, 2024. https://www.businesswire.com/news/home/20240923600460/en/FDA-Accepts-LEO-Pharma%E2%80%99s-Filing-of-Delgocitinib-Cream-New-Drug-Application-for-the-Treatment-of-Chronic-Hand-Eczema. Date accessed: February 28, 2025.