- The Lancet publishes data from the pivotal DELTA 1 and DELTA 2
trials, marking the first time an investigational topical pan-Janus
kinase (JAK) inhibitor for chronic hand eczema (CHE) has been
featured in the journal.1
- The DELTA 1 and DELTA 2 trials investigated the safety and
efficacy of investigational delgocitinib cream in adult patients
with moderate to severe CHE.2,3
NOT FOR UK USE – NOT INTENDED FOR UK MEDIA
LEO Pharma A/S, a global leader in medical dermatology, today
announced that the findings of the DELTA 1 and DELTA 2 phase 3
clinical trials for delgocitinib cream have been published in The
Lancet,1 which is considered one of the most influential
peer-reviewed periodicals in the world. This is the first time The
Lancet has published data on an investigational topical pan-Janus
kinase (JAK) inhibitor for the treatment of moderate to severe
CHE.
The publication summarizes the randomized, double-blinded,
multi-center vehicle-controlled clinical phase 3 DELTA 1 and DELTA
2 trials. These trials evaluated the safety and efficacy of
investigational delgocitinib cream compared to cream vehicle in
adult patients with moderate to severe CHE who had inadequate
response to, or for whom topical corticosteroids were medically
inadvisable.2,3 Delgocitinib cream is currently under investigation
and has not been approved by any health authority.
“Having the DELTA 1 and 2 trial results featured in one of the
most highly regarded peer-reviewed medical journals in the world is
a vital step on our mission to raise awareness and develop
potential new treatment options for those living with CHE,” said
Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma.
“The publication of our research in The Lancet is a proud milestone
for everyone who has worked tirelessly on the DELTA 1 and 2 trials,
and proves LEO Pharma’s commitment to pioneering new potential
treatment options for those living with skin conditions. We are
excited to share this analysis with the broader scientific and
medical community to help drive further research advances for
CHE.”
Primary and all secondary endpoints were met in both DELTA 1 and
DELTA 2 trials.2,3
“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,” commented Dr.
Robert Bissonnette, Lead Author and MD from Innovaderm Research,
Montreal. “Publication of milestones like this have a valuable role
in our efforts to improve the day-to-day reality of those living
with CHE.”
About The Lancet
The Lancet is a world-leading source of clinical, public health,
and global health knowledge. Lancet journals have an extensive
global reach with more than 36.6 million annual visits and 108.1
million downloaded articles.4
About the DELTA 1, 2 and 3 Trials
The primary objective for the randomized, double-blind,
vehicle-controlled, multi-center phase 3 clinical trials (DELTA 1
and DELTA 2) was 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.2,3
The primary endpoint of the trials was the Investigator’s Global
Assessment for chronic hand eczema treatment success (IGA-CHE TS)
at Week 16. Treatment success was defined as an IGA-CHE score of 0
(clear) or 1 (almost clear) with at least a two-step improvement
from baseline. Additional IGA-CHE scores included 2 (mild), 3
(moderate), and 4 (severe).2,3
Key secondary endpoints at Week 16 included reduction of itch
and pain scores of ≥4 points measured by the Hand Eczema Symptom
Diary (HESD) from baseline to Week 16, 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. The
number of treatment-emergent adverse events from baseline to Week
16 defined the key safety endpoint of the trials. 2,3
Subjects who completed 16 weeks of treatment with delgocitinib
cream or cream vehicle twice daily in trials DELTA 1 or DELTA 2
were offered to roll-over to the DELTA 3 open-label, multi-site 36
week, extension trial. The purpose of this extension trial was to
evaluate the long-term safety of delgocitinib.5
About Chronic Hand Eczema
Chronic hand eczema (CHE) is defined as hand eczema (HE) that
lasts for more than three months or relapses twice or more within a
year.6.7 HE is the most common skin disorder of the hands with a
one-year prevalence rate of approximately 9%.8,9 In a substantial
number of patients, HE can develop into a chronic condition.8 CHE
is a fluctuating disorder characterized by itch and pain, and
patients may experience signs such as erythema, scaling,
lichenification, hyperkeratosis, vesicles, edema, and fissures on
hands and wrists.10
CHE has been shown to cause psychological and functional burdens
that impact patient quality of life,11 with approximately 70% of
individuals who live with severe CHE admitting to problems in
performing everyday activities, and suffering disruption in their
daily life due to the condition.12 Furthermore, careers and earning
potential have also been shown to be impacted by the burden of
living with CHE.13
About delgocitinib cream
Delgocitinib cream is an investigational, potential
first-in-class, topical pan-Janus kinase (JAK) inhibitor for CHE.
It inhibits the activation of JAK-STAT signaling, which plays a key
role in the pathogenesis of CHE.14 The pathophysiology is
characterized by skin barrier dysfunction, inflammation of the
skin, and alterations of the skin microbiome.15 LEO Pharma is
currently developing delgocitinib in a cream formulation for the
treatment of moderate to severe chronic hand eczema (CHE) in
adults, which is currently not approved by any health authority. 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.
About LEO Pharma
LEO Pharma is a global company dedicated to advancing the
standard of care for the benefit of people with skin conditions,
their families and society. Founded in 1908 and majority owned by
the LEO Foundation, LEO Pharma has devoted decades of research and
development to advance the science of dermatology, and today, the
company offers a wide range of therapies for all disease
severities. LEO Pharma is headquartered in Denmark with a global
team of 4,200 people, serving millions of patients across the
world. In 2023, the company generated net sales of DKK 11.4
billion.
References
- Bissonnette R, Warren RB, Pinter A, et al. 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. Lancet 2024;
published online July 18.
- ClinicalTrials.gov. National Library of Medicine (U.S.).
Efficacy and Safety of Delgocitinib Cream in Adults With Moderate
to Severe Chronic Hand Eczema (DELTA 1). Identifier: NCT04871711.
https://clinicaltrials.gov/ct2/show/NCT04872101.
- ClinicalTrials.gov. National Library of Medicine (U.S.).
Efficacy and Safety of Delgocitinib Cream in Adults With Moderate
to Severe Chronic Hand Eczema (DELTA 2). Identifier: NCT04872101.
https://clinicaltrials.gov/ct2/show/NCT04872101.
- The Lancet. About The Lancet. Published: 2024. Last assessed:
Jun 25, 2024. Available at:
https://www.thelancet.com/lancet/about.
- ClinicalTrials.gov. National Library of Medicine (U.S.).
Open-label Multi-site Extension Trial in Subjects Who Completed the
DELTA 1 or DELTA 2 Trials (DELTA3). Identifier: NCT04949841
https://clinicaltrials.gov/ct2/show/NCT04949841.
- Lynde C, Guenther L, Diepgen TL, et al. Canadian hand
dermatitis management guidelines. J Cutan Med Surg.
2010;14(6):267-284. Erratum in: J Cutan Med Surg. 2011
Nov-Dec;15(6):360.
- Diepgen TL, et al. Guidelines for diagnosis, prevention and
treatment of hand eczema. J Dtsch Dermatol Ges. 2015
Jan;13(1):e1–22.
- Bissonnette R, et al. Redefining treatment options in chronic
hand eczema (CHE). JEADV. 2010;24;1–20.
- Thyssen, et al. The epidemiology of hand eczema in the general
population – prevalence and main findings. Contact Dermatitis.
2010;62:75-87.
- Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for
diagnosis, prevention, and treatment of hand eczema. Contact
Dermatitis. 2022;86(5):357-378.
- Grant L, Seiding Larsen L, Burrows K, et al. Development of a
Conceptual Model of Chronic Hand Eczema (CHE) Based on Qualitative
Interviews with Patients and Expert Dermatologists. Adv Ther.
2020;37(2):692-706.
- Cortesi PA, Scalone L, Belisari A, et al. Cost and quality of
life in patients with severe chronic hand eczema refractory to
standard therapy with topical potent corticosteroids. Contact
Dermatitis. 2014;70(3):158-168.
- Voorberg AN, Loman L, Schuttelaar MLA. Prevalence and Severity
of Hand Eczema in the Dutch General Population: A Cross-sectional,
Questionnaire Study within the Lifelines Cohort Study. Acta Derm
Venereol. 2022;102:adv00626.
- Dubin C, Del Duca E, Guttman-Yassky E. Drugs for the Treatment
of Chronic Hand Eczema: Successes and Key Challenges. Ther Clin
Risk Manag. 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag.
2021 Mar 18;17:233.
- Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and
emerging therapies for hand eczema. Dermatol Ther.
2019;32(3):e12840.
MAT-74844
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240718072831/en/
Jes Broe Frederiksen Global Commercial Communication +45 53 60
59 48 jebfe@leo-pharma.com
Jeppe Ilkjær Global Corporate Communications +45 3050 2014
JEILK@leo-pharma.com