LEO Pharma initiates the first Phase 3 clinical trial with delgocitinib cream in adult patients with moderate-to-severe chronic hand eczema (CHE)
NOT FOR DISTRIBUTION IN THE UK OR IRELAND BALLERUP, Denmark, 18 May 2021 -- LEO Pharma A/S, a global leader in medical dermatology, today announced it has enrolled the first adult patient in the first of two pivotal Phase 3 clinical trials with delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, for the potential treatment of adult patients with moderate-to-severe chronic hand eczema (CHE).
Delgocitinib inhibits activation of the JAK-STAT pathway, which plays a key role in the immune system in driving the pathophysiology of chronic inflammatory skin diseases.[i],[ii] The cream formulation of delgocitinib is an investigational therapy under clinical development and has not been approved by any regulatory authority.
The primary objective for the randomized, double-blind, vehicle-controlled, multi-center Phase 3 clinical trials (DELTA 1 and DELTA 2) is to evaluate the efficacy of twice-daily applications of delgocitinib cream 20 mg/g compared with vehicle in the treatment of adults with moderate-to-severe CHE.[iii],[iv]
The primary endpoint of the trials is the Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at Week 16.3,4 Treatment success is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline.3,4
Key secondary endpoints at Week 16 include reduction of itch and pain scores of ≥4 points measured by the Hand Eczema Symptom Diary (HESD) from baseline to Week 16,3,4 as well as at least 75% improvement from baseline and at least 90% improvement from baseline on the Hand Eczema Severity Index (HECSI) at Week 16.3,4 The number of treatment-emergent adverse events per patient from baseline to Week 16 defines the key safety endpoint of the trials.3,4
"Managing moderate-to-severe CHE is challenging because of limited available treatment options for chronic use,” said Dr. Sibylle Schliemann, Consultant, Department of Dermatology, University Hospital Jena, Germany and lead investigator for DELTA 2. “These trials will evaluate whether delgocitinib cream can potentially offer a new treatment option for adult patients with moderate-to-severe CHE who suffer from a considerable burden of disease.”
CHE is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year.[v],[vi] HE is the most common skin disorder of the hands[vii] that affects an estimated 1 – 5% of the general population[viii] with a one-year prevalence rate of approximately 10%.[ix] It is an inflammatory, non-infectious skin disorder of the hands and wrists5,[x]and can cause itching, blisters, swelling and pain so severe that it can impair the ability to work.5,7,[xi]In a substantial number of patients, HE can develop into a chronic condition.7
“We have been encouraged by the positive results from the Phase 2b CHE clinical trial with delgocitinib cream and look forward to learning whether it has the potential to offer benefits to adult patients through a larger Phase 3 clinical development program,” said Dr. Jörg Möller, Executive Vice President, Global Research & Development, LEO Pharma. “We are committed to developing innovative therapies that may help improve the lives of patients who need more treatment options for skin diseases.”
[i] Damsky W, and King BA. JAAD; 2017;76(4):736-744.
[ii] Virtanen AT, et al. BioDrugs. 2019;33:15–32.
[iii] ClinicalTrials.Gov: https://clinicaltrials.gov/ct2/show/NCT04871711?term=delgocitinib&draw=1&rank=8 (Accessed May 2021).
[iv] ClinicalTrials.Gov: https://clinicaltrials.gov/ct2/show/NCT04872101?term=delgocitinib&draw=1&rank=7 (Accessed May 2021).
[v]Lynde C, et al. J Cutan Med Surg. 2010;14:267–84.
[vi]Diepgen TL, et al. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1–22. doi: 10.1111/ddg.12510_1.
[vii] Bissonnette R, et al. JEADV. 2010;24;1–20.
[viii] Christoffers WA, et al. Cochrane Database Syst Rev. 2019;4:CD004055.
[ix] Thyssen, et al. Contact Dermatitis. 2010;62:75-87.
[x]Menné T, et al. Contact Dermatitis. 2011;65:3–12.
[xi]Politiek K, et al. Contact Dermatitis. 2016;75:67–76.
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About LEO Pharma
In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights.
In 2020, LEO Pharma completed a multi-center, randomized Phase 2b dose-finding clinical trial with twice-daily topical delgocitinib cream for the treatment of adults with mild-to-severe CHE. The company presented top-line results of the trial at the European Academy of Dermatology and Venereology (EADV) Virtual 2020[i] and presented the results of HECSI measurements during the trial at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021.[ii]
About LEO Pharma
LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries. In 2020, the company generated net sales of DKK 10,133 million. For more information please visit www.LEO-Pharma.com.
[i] Worm M, et al. The topical pan-JAK inhibitor delgocitinib cream demonstrates dose response in a 16-week phase 2b trial in chronic hand eczema. Presented during the Late Breaking News session of the European Academy of Dermatology and Venereology (EADV) Virtual 2020 on 29 October 2020.
[ii] Soerensen P, et al. A phase 2b trial evaluating the efficacy of delgocitinib cream for the treatment of chronic hand eczema (CHE) using and validating the Hand Eczema Severity Index (HECSI). E-poster presented at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 23-25 April 2021.
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