- Results demonstrated that delgocitinib cream provided
statistically significant improvements in primary and all key
secondary endpoints, which included both clinician-assessed and
patient-reported efficacy outcomes compared to cream vehicle.1
- Delgocitinib cream showed a statistically significant treatment
effect compared to cream vehicle as early as four weeks after
initiation of treatment.1
LEO Pharma A/S, a global leader in medical dermatology, today
presented positive results from the DELTA 1 trial in one of two LEO
Pharma late-breaking sessions at the American Academy of
Dermatology (AAD) 2023 Annual Meeting.1 DELTA 1 is a pivotal phase
3 clinical trial with delgocitinib cream, an investigational
topical pan-Janus kinase (JAK)-inhibitor for the potential
treatment of adults with moderate to severe chronic hand eczema
(CHE).2 The safety and efficacy of delgocitinib cream is under
investigation and has not been evaluated by any health
authority.
The DELTA 1 trial randomized 487 adults with moderate-to-severe
CHE to twice-daily delgocitinib cream 20 mg/g (n=325) or cream
vehicle (n=162) for 16 weeks followed by a 36-week extension trial.
The primary endpoint was the proportion of patients with moderate
to severe CHE who achieved an Investigator’s Global Assessment
(IGA)-CHE score of 0 (clear) or 1 (almost clear: barely perceptible
erythema only) with a ≥2 point improvement from baseline at Week
16. A significantly greater proportion of delgocitinib-treated
patients, compared to cream vehicle, achieved this IGA-CHE
improvement (19.7% vs. 9.9%; p=0.006). Similar differences were
observed at Week 4 (15.4% vs. 4.9%; p<0.001) and Week 8 (22.8%
vs. 10.5%; p=0.001).1
The trial also achieved its key secondary endpoints at Week 16.
A significantly greater proportion of delgocitinib-treated patients
achieved a ≥75% improvement in Hand Eczema Severity Index
(HECSI-75) compared to cream vehicle (49.2% vs. 23.5%; p<0.001).
A similar trend was observed in those achieving a ≥90% improvement
(HECSI-90) (29.5% vs. 12.3%; p<0.001).1
The Dermatology Life Quality Index (DLQI) was another key
secondary endpoint used to measure patient-reported efficacy. A
≥4-point improvement was observed in 74.4% of delgocitinib-treated
patients compared to 50.0% for cream vehicle (p<0.001).1
Over the 16-week trial period, no difference was observed
between delgocitinib and cream vehicle in the proportion of
patients who presented adverse events (AEs) and serious AEs. Rates
of AEs, AEs probably or possibly related to study drug or AEs
leading to discontinuation of study drug were numerically higher
with cream vehicle compared to delgocitinib from baseline to trial
completion (delgocitinib 45.2% vs. cream vehicle 50.6%, 3.7% vs.
8.0% and 0.6% vs. 3.7%, respectively). The most common AEs (≥5% in
any treatment group) during the study were COVID-19 infections and
nasopharyngitis and rates were comparable between the treatment
arms.1
“There is a high unmet need for a topical treatment specifically
tailored for moderate-to-severe CHE for patients living with this
hard-to-treat disease”, said Robert Bissonnette, MD, FRCPC,
President of Innovaderm Research in Quebec, Canada, and the
International Coordinating Investigator (ICI) of DELTA 1. “These
positive results, which show significant improvements in primary
and all key secondary endpoints, demonstrate that delgocitinib
cream, if approved, can be a much-needed topical treatment option
for patients living with moderate-to-severe CHE.”
Subjects who completed 16 weeks of treatment in trials DELTA 1
or DELTA 2 were offered to roll-over to the DELTA 3 extension trial
evaluate the long-term safety and efficacy of an as-needed
treatment with twice-daily applications of delgocitinib cream.4
“I’m personally very excited about LEO Pharma’s broad data
representation at this year’s AAD, which demonstrates our strong
commitment to advancing medical dermatology,” said Christophe
Bourdon, Chief Executive Officer, LEO Pharma. “CHE is a
debilitating, difficult-to-treat disease that negatively impacts
patient quality of life, physical functioning, and ability to work.
We are incredibly excited to share the positive results of this
trial, which demonstrates the potential that delgocitinib cream has
as a first-in-class innovative topical treatment.”
For more information on the DELTA 1 trial (NCT04871711) go to
clinicaltrials.gov.
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) is to evaluate the 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 is the Investigator’s Global
Assessment for chronic hand eczema treatment success (IGA-CHE TS)
at Week 16. Treatment success is defined as an IGA-CHE score of 0
(clear) or 1 (almost clear, with little or no disease left) with at
least a two-step improvement from baseline. Additional IGA-CHE
scores include 2 (mild), 3 (moderate), and 4 (severe).
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, 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 defines the key safety endpoint of the trials.
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 extension trial. The
purpose of this extension trial is to evaluate the long-term
effects of delgocitinib.4
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.5,6 HE is the most common skin disorder of the hands7 with a
one-year prevalence rate of approximately 9%.8 In a substantial
number of patients, HE can develop into a chronic condition.7 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.9
About delgocitinib
Delgocitinib is a first-in-class investigational topical
pan-Janus kinase (JAK)-inhibitor that 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.10,11 LEO Pharma is currently developing delgocitinib in a
cream formulation for the treatment of moderate to severe chronic
hand eczema (CHE) in adults.
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 4,700 people, serving millions of patients across the
world. In 2022, the company generated net sales of DKK 10.6
billion.
References:
- Bissonnette R, Warren RB, Stingeni L, et al. Efficacy and
safety of delgocitinib cream in adults with moderate-to-severe
chronic hand eczema: results of the Phase 3 DELTA 1 trial.
Presented at American Academy of Dermatology (AAD) 2023 Annual
Meeting, New Orleans, La., March 17-21, 2023.
- 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.
- 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.
- Diepgen TL, Andersen KE, Chosidow O, et al. Guidelines for
diagnosis, prevention and treatment of hand eczema. J Dtsch
Dermatol Ges. 2015;13(1):e1-e22.
- Bissonnette R, Diepgen TL, Elsner P, et al. Redefining
treatment options in chronic hand eczema (CHE). J Eur Acad Dermatol
Venereol. 2010;24 Suppl 3:1-20.
- Thyssen JP, Johansen JD, Linneberg A, Menné T. The epidemiology
of hand eczema in the general population--prevalence and main
findings. Contact Dermatitis. 2010;62(2):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.
- Damsky W, King BA. JAK inhibitors in dermatology: The promise
of a new drug class. J Am Acad Dermatol. 2017;76(4):736-744.
doi:10.1016/j.jaad.2016.12.005.
- T Virtanen A, Haikarainen T, Raivola J, Silvennoinen O.
Selective JAKinibs: Prospects in Inflammatory and Autoimmune
Diseases. BioDrugs. 2019;33(1):15-32.
MAT-64451 March 2023
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version on businesswire.com: https://www.businesswire.com/news/home/20230318005013/en/
Jes Broe Frederiksen (On US CST time zone from March 16-19) LEO
Pharma, Global Communications Manager Tel: +45 53 60 59 48 Email:
jebfe@leo-pharma.com
Henrik Heskjær LEO Pharma, Director, Global External
Communications Tel: +45 3140 6180 Email: hdtdk@leo-pharma.com