DELTA TEEN Trial Demonstrates Superiority of Delgocitinib Cream in Adolescents With Chronic Hand Eczema

LEO Pharma recently presented 2 late-breaking data sets on delgocitinib cream (Anzupgo) for chronic hand eczema (CHE) at the European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, France, including results from the phase 3 DELTA TEEN trial (NCT05355818) and a pooled safety analysis across 5 phase 2b and phase 3 trials.¹

The DELTA TEEN trial (n=98) evaluated delgocitinib cream in adolescents aged 12 to 17 years with moderate to severe CHE who were unsuitable for topical corticosteroids. The study met its primary end point of Investigator’s Global Assessment for CHE Treatment Success (IGA-CHE TS) at week 16, with 63.5% of patients in the delgocitinib arm achieving treatment success compared with 29.2% in the cream vehicle arm.

“Currently, there are no approved therapies, neither EMA nor FDA, for adolescents with chronic hand eczema," said Alexander Egeberg, MD, PhD, professor of dermatology and the global head of medical affairs at LEO Pharma, in a previous interview with Dermatology Times. "As a clinician, I can tell you that this population does have a high unmet need. If approved, this will really be a promising option."

Key secondary end points were also met. Patients achieved ≥90% improvement in the Hand Eczema Severity Index (HECSI-90) in 71.6% of cases vs 37.5% with cream vehicle. Improvements in Hand Eczema Symptom Diary (HESD) scores were also superior in the delgocitinib arm for itch (64.8% vs. 36.8%), pain (63.3% vs. 33.3%), and total score (55.6% vs. 31.3%). No serious adverse events were reported, with most adverse events mild to moderate in severity.

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

The second late-breaking presentation detailed pooled safety data from 5 phase 2b and phase 3 trials of delgocitinib cream, with follow-up up to 52 weeks. The analysis compared safety outcomes with cream vehicle and oral alitretinoin. During the initial treatment period, adverse event rates (R) with delgocitinib cream (R=302.1) were similar to cream vehicle (R=337.5) and lower than oral alitretinoin (R=830.2). Safety during the as-needed treatment phase was consistent, with adverse event rates decreasing over time.

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

“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, and innovation at LEO Pharma, in the news release. “Nearly half of CHE patients feel they are a burden to their families, and around 63% avoid holding hands with their partners, highlighting the profound everyday impact this disease can have on patients’ lives. These figures are more than just statistics; they reflect the real and often unseen challenges faced by those living with CHE. At LEO Pharma, we are dedicated to reducing the burden of this skin condition, which we acknowledge affects far more than just the skin.”

Delgocitinib was approved in July 2025 for adults with moderate to severe CHE who have not responded adequately to prior topical corticosteroids or for whom corticosteroid use is not advisable.²

Approval of the steroid-free, topical pan-JAK inhibitor is supported by positive data from the phase 3 DELTA-1 and DELTA-2 clinical trials. These randomized, double-blind, vehicle-controlled studies enrolled a total of 960 adult patients with CHE to assess the cream’s safety and efficacy over 16 weeks.2

References

1. LEO Pharma presents late-breaking phase 3 delgocitinib cream data in adolescents with moderate to severe chronic hand eczema (CHE). News release. Business Wire. September 18, 2025. Accessed September 19, 2025. https://www.businesswire.com/news/home/20250918307792/en/LEO-Pharma-Presents-Late-Breaking-Phase-3-Delgocitinib-Cream-Data-in-Adolescents-with-Moderate-to-Severe-Chronic-Hand-Eczema-CHE
2. Anzupgo (delgocitinib) cream is now the first and only FDA-approved treatment for moderate-to-severe chronic hand eczema (CHE) in adults. News release. LEO Pharma Inc. July 23, 2025. Accessed September 19, 2025. https://www.businesswire.com/news/home/20250723115252/en/ANZUPGO-delgocitinib-Cream-Is-Now-the-First-and-Only-FDA-Approved-Treatment-for-Moderate-to-Severe-Chronic-Hand-Eczema-CHE-in-Adults