Pooled Phase 2/3 Data on Delgocitinib Illustrate Consistent Safety Profile in CHE

Insights from an analysis of nearly a half dozen phase 2 and phase 3 trials of delgocitinib are shedding additional light on the safety and efficacy of the agent in management of chronic hand eczema (CHE).

Presented at the European Association of Dermatology and Venereology (EADV) 2025 Congress, the data help to solidify clinicain's understanding of delgocitinib's consistent safety profile for the treatment of moderate to severe CHE in adults, which became the first agent to receive approval for this indication from the US Food and Drug Administration in July 2025.1,2,3

“The results from the pooled safety analysis are incredibly valuable as they further strengthen our understanding of this treatment option,” said lead investigator Robert Bissonnette, MD, chairman at Innovaderm Research.1 “It is reassuring to see that the safety data pooled from five clinical trials remains consistent with previously established findings.”

Excitement surrounding delgocitinib cream has been building since the debut of phase 3 results from LEO Pharma in October 2023. Since results from the DELTA program were first presented, excitement has reached a fever pitch with the announcement of its approval in July 2025 and, in early September 2025, LEO Pharma announced delgocitinib cream was now available in the US.

The analysis included data from the following trials:

• DELTA FORCE
• DELTA 1
• DELTA 2
• DELTA 3
• Phase 2b Dose-Finding Trial (NCT03683719)

Results of the analysis, which focused primarily on safety outcomes from the trials, the event rates (R) of AEs with delgocitinib cream (R=302.1) were similar to cream vehicle (R=337.5) and lower than oral alitretinoin (R=830.2) during the initial treatment period. When assessing data from the as-needed treatment period, results indicated the safety profile of delgocitinib cream remained consistent with the initial treatment period, with event rates decreasing in frequency over time.1,2

“We remain deeply committed to further raising awareness of CHE and expanding our extensive scientific research, not only to advance medical dermatology, but, most importantly, to support those living with this debilitating condition,” said Jacob Pontoppidan Thyssen, PhD, chief scientific officer and executive vice president of Science, Search & Innovation at LEO Pharma.1

In the same late-breaking session as this data was released, Sonja Molin, MD, presented data from the landmark DELTA TEEN trial. The trial was a phase 3 study of the agent in patients aged 12 to 17 years with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate.1

The trial had a primary endpoint of Investigator’s Global Assessment for CHE Treatment Success (IGA CHE TS) at week 16, which was defined as an IGA-CHE score of 0/1 (clear/almost clear) with a ≥2 step improvement from baseline. Results from the trial suggested 63.5% of patients achieved the primary endpoint in the delgocitinib cream arm relative to 29.2% in the cream vehicle arm by week 16.1

“These results are encouraging and bring us one step closer to advancing the standard of care for this underserved patient group, helping to fulfill their unmet dermatological needs,” said DELTA TEEN investigator Sonja Molin, MD, an academic dermatologist at Charite Universitätsmedizin Berlin and adjunct associate professor of Dermatology at Queen’s University.1

References:

1. LEO Pharma. LEO Pharma Presents Late-Breaking Phase 3 Delgocitinib Cream Data in Adolescents with Moderate to Severe Chronic Hand Eczema (CHE). Leo-pharma.com. Published September 18, 2025. Accessed September 18, 2025. https://www.leo-pharma.com/media-center/news/2025-delgocitinib-late-breaker

2. Bissonnette R. Safety of delgocitinib cream in adult patients with Chronic Hand Eczema (CHE): pooled analysis of five phase 2b and phase 3 trials. Presented at the European Association of Dermatology and Venereology (EADV) 2025 Congress. Paris, France. September 17-20, 2025.

3. National Eczema Association. LEO Pharma Announces FDA Approval of ANZUPGO® (delgocitinib) Cream in the U.S. National Eczema Association. Published July 25, 2025. Accessed September 18, 2025. https://nationaleczema.org/blog/leo-pharma-announces-fda-approval-of-anzupgo-delgocitinib-cream-in-the-u-s/