LEO Pharma Reveals Groundbreaking Data From Duo of Chronic Hand Eczema Phase III Clinical Trials
Results of the studies, published in The Lancet, show delgocitinib cream met its primary and all secondary endpoints.
Emerging data from the Phase III DELTA 1 (NCT04871711) and DELTA 2 (NCT04872101) clinical trials for the treatment of chronic hand eczema (CHE) with delgocitinib cream show that the primary and all secondary endpoints were met. The full results of both trials have been published in The Lancet.1
According to LEO Pharma, this is the first time The Lancet has published data of an investigational topical pan-Janus kinase (JAK) inhibitor for CHE.
Both Phase III studies were randomized, double-blind, vehicle-controlled, multi-center clinical trials to evaluate the safety and efficacy of twice-daily applications of delgocitinib cream compared with cream vehicle in the treatment of adults with moderate to severe CHE. The primary endpoint of the trials was the Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at week 16. Key secondary endpoints included reduction of itch and pain scores of ≥4 points measured by the Hand Eczema Symptom Diary (HESD) as well as at least 75% improvement from baseline and at least 90% improvement from baseline on the Hand Eczema Severity Index (HECSI).
Additionally, participants who completed the 16-week treatment were offered to roll-over to the Phase III DELTA 3 study (NCT04949841), an open-label, multi-site, 36-week, extension trial to evaluate delgocitinib’s long-term safety.
Data from the DELTA 1 and 2 studies published in The Lancet show a greater proportion of delgocitinib-treated patients versus cream vehicle patients had IGA-CHE treatment success across both trials.2
“Historically, CHE has been under researched, so the publication of the DELTA 1 and 2 trials in The Lancet is a positive step towards highlighting the condition, and in turn indicates the increased quality and rate of research in the space,” Robert Bissonnette, MD, lead author from Innovaderm Research said in a press release. “Publication of milestones like this have a valuable role in our efforts to improve the day-to-day reality of those living with CHE.”
Earlier this year in January, LEO shared positive results from its head-to-head Phase III DELTA FORCE trial (NCT05259722) which compared delgocitinib cream with alitretinoin capsules in adults with CHE.3
Delgocitinib cream met its primary outcome measure in the two-arm, 24-week trial, demonstrating a superior reduction in HECSI score from baseline to week 12 compared to alitretinoin capsules.
“Our hands are integral to everything we do. I have heard countless stories from patients about just how much this condition impacts their everyday lives socially, psychologically and physically. CHE often limits their ability to work,” Alexander Egeberg, head of global medical affairs, LEO Pharma said in an earlier press release. “With such a considerable unmet need for patients living with CHE, we are proud to have conducted this study, which we hope can drive forward a potential new treatment option with delgocitinib cream.”
References
1. LEO Pharma Announces Publication of Chronic Hand Eczema Phase 3 Data in The Lancet. News release. LEO Pharma. July 19, 2024. Accessed July 22, 2024. https://www.businesswire.com/news/home/20240718072831/en/LEO-Pharma-Announces-Publication-of-Chronic-Hand-Eczema-Phase-3-Data-in-The-Lancet
2. Bissonnette, R. et al. (2024, July 18). Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. The Lancet. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01027-4/abstract
3. LEO Pharma Announces Positive Phase 3 Head-to-head Data Results from DELTA FORCE Trial Comparing Delgocitinib Cream With Alitretinoin Capsules in Adults With Severe Chronic Hand Eczema (CHE). News release. LEO Pharma. January 24, 2024. Accessed July 22, 2024. https://www.businesswire.com/news/home/20240123989016/en/LEO-Pharma-Announces-Positive-Phase-3-Head-to-head-Data-Results-from-DELTA-FORCE-Trial-Comparing-Delgocitinib-Cream-With-Alitretinoin-Capsules-in-Adults-With-Severe-Chronic-Hand-Eczema-CHE
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Roche’s Susvimo Lands FDA Approval for Diabetic Retinopathy Based on Phase III Pavilion Trial Data
May 22nd 2025One-year results from the Pavilion study showed patients who received Susvimo (ranibizumab) refilled every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale.
FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research
May 21st 2025In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.
