Delgocitinib Cream Shows Positive Responses in Moderate to Severe Chronic Hand Eczema

New data from the Phase 3 DELTA 1 and DELTA 2 trials demonstrated clinically meaningful improvements with delgocitinib cream in a subgroup of adults with moderate to severe chronic hand eczema (CHE), according to a company news release.¹

The results announced by LEO Pharma were presented as late-breaking research at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando. In addition, new systemic exposure data from DELTA 2 were reported in a separate e-poster.¹

In a post hoc subgroup analysis, delgocitinib cream improved measures of CHE severity across several domains compared to vehicle cream. Patients were evaluated over a 16-week treatment period, with the subgroup defined as those who achieved:

Deep Response:

• Hand Eczema Symptom Diary (HESD) itch score of 0 or 1: 30.0% vs 9.4% (delgocitinib vs vehicle)
• HESD pain score of 0 or 1: 35.2% vs 16.0%
• Dermatology Life Quality Index (DLQI) score of 0 or 1: 33.3% vs 13.9%.¹

Consistent Response:

• ≥4-point reduction in HESD itch: 24.1% vs 6.6%
• ≥4-point reduction in HESD pain: 25.0% vs 9.0%
• ≥75% improvement in Hand Eczema Severity Index (HECSI-75): 27.3% vs 8.1%.¹

Maintained Response:

• Among delgocitinib-treated patients who achieved an Investigator’s Global Assessment (IGA)-CHE score of 0 (clear) at Week 16, 32.9% maintained that score for 8 weeks off treatment and 15.7% maintained it at 16 weeks off treatment.¹

"It is so exciting to see such a strong response in a subgroup of patients treated with delgocitinib cream," said April W Armstrong, MD, Professor and Chief of Dermatology at the University of California-Los Angeles, in the news release. "The results across the various treatment metrics are promising and demonstrate the future potential that delgocitinib cream may have in offering a new treatment option for those living with this unique and burdensome disease."¹

A separate poster presented new systemic exposure data from the DELTA 2 trial. Twice-daily delgocitinib cream use under “high use” conditions in moderate to severe CHE demonstrated negligible systemic absorption, consistent with findings from a Phase 1 trial in adults with atopic dermatitis. Systemic exposure levels were also well below those observed with the lowest oral dose tested in healthy adults.¹

The DELTA 1 and DELTA 2 Phase 3 trials each randomized adults with moderate to severe CHE to receive either delgocitinib cream twice daily or vehicle cream over 16 weeks, followed by an optional 36-week open-label extension (DELTA 3). Primary endpoints included IGA-CHE treatment success (score of 0 or 1 with a ≥2-step improvement from baseline) at Week 16. Additional endpoints comprised reductions in itch, pain, and improvements in HECSI (75% and 90% improvement from baseline).¹

Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor under investigation in the United States. It has been approved in the European Union, the United Kingdom, Switzerland, and the United Arab Emirates under the brand name Anzupgo for moderate to severe CHE in adults for whom topical corticosteroids are inadequate or inappropriate. Delgocitinib inhibits the JAK-STAT pathway, which plays a central role in the inflammatory process underlying chronic hand eczema.¹

Reference

1. LEO Pharma A/S. LEO Pharma Presents New Late-Breaking Delgocitinib Cream Data for the Third Consecutive Year at AAD 2025 [news release]. March 8, 2025. Accessed March 9, 2025. https://www.leo-pharma.com/media-center/news/2025_aad-late-breaker-press-release