Phase 3 Data Support Efficacy of Delgocitinib Cream in Adolescents With Chronic Hand Eczema; Pooled Analysis Confirms Safety in Adults

Robert Bissonnette, MD

Courtesy of the International Psoriasis Council

Late-breaking findings presented at the 34th European Academy of Dermatology and Venereology (EADV) Congress highlighted efficacy and safety outcomes with delgocitinib cream in chronic hand eczema (CHE), including phase 3 data in adolescents and pooled analyses of safety in adults.1

The new data may help to solidify clinician'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 FDA in July 2025.1,2,3

The 16-week DELTA TEEN phase 3 trial enrolled 98 adolescents aged 12 to 17 years with moderate to severe CHE that was inadequately controlled or inappropriate for treatment with topical corticosteroids. At week 16, 63.5% of participants treated with delgocitinib cream achieved Investigator’s Global Assessment for CHE Treatment Success compared with 29.2% in the cream vehicle arm.1,2

“The findings from the phase 3 DELTA TEEN trial may offer hope for young people whose CHE can impact their wellbeing and leisure activities,” Sonja Molin, MD, academic dermatologist at Charite Universitätsmedizin Berlin, adjunct associate professor of dermatology at Queen’s University and coordinating investigator of the DELTA TEEN study, said in a press release. “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.”1

Secondary outcomes also demonstrated consistent benefits. More patients treated with delgocitinib achieved a ≥90% improvement in the Hand Eczema Severity Index (71.6% vs 37.5%). Reductions in Hand Eczema Symptom Diary scores for itch (64.8% vs 36.8%), pain (63.3% vs 33.3%), and total symptoms (55.6% vs 31.3%) were observed with delgocitinib compared with vehicle.1,2

Safety data from DELTA TEEN showed no serious adverse events. All adverse events were mild or moderate, and while the overall rate was slightly higher with delgocitinib than vehicle, events leading to treatment withdrawal or discontinuation were lower with the active treatment. Delgocitinib is not currently approved for use in patients younger than 18 years, and efficacy and safety in this age group have not been evaluated by regulatory authorities.1,2

A second late-breaking presentation detailed results from a pooled safety analysis of 5 phase 2b and 3 trials of delgocitinib in adults with CHE, with treatment durations of up to 52 weeks. During the initial treatment period, adverse event rates were similar with delgocitinib cream (302.1 per patient-year) and cream vehicle (337.5 per patient-year), and lower than oral alitretinoin (830.2 per patient-year). Event rates declined with continued use in the as-needed period, with no new safety signals identified.1

Investigators concluded that the phase 3 DELTA TEEN data establish delgocitinib cream as an effective and generally well-tolerated therapy for adolescents with CHE, while pooled analyses support its safety profile in adults during both short- and long-term use.1,2

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

References:

1. LEO Pharma. LEO Pharma Presents Late-Breaking Phase 3 Delgocitinib Cream Data in Adolescents with Moderate to Severe Chronic Hand Eczema (CHE). News release. 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/