LEO Pharma Announces Publication of Head-to-Head DELTA FORCE Study Results in The Lancet

LEO Pharma A/S, a global leader in medical dermatology, is pleased to share that The Lancet, which is considered one of the most influential peer-reviewed medical journals in the world, has published an article discussing the findings of the DELTA FORCE trial for investigational delgocitinib cream.

The publication summarizes the results of DELTA FORCE, a phase 3, two-arm trial (N=513) that compares the efficacy and safety of delgocitinib cream with alitretinoin capsules.¹ Alitretinoin is the only treatment currently approved in Canada to treat severe CHE in patients who do not respond to topical corticosteroids.² In Canada and the US, delgocitinib cream is currently under review and has not been approved by Health Canada or the FDA.

Delgocitinib cream achieved the primary outcome measure of the DELTA FORCE trial, assessing the Hand Eczema Severity Index (HECSI) scores from baseline to Week 12 compared to alitretinoin capsules.

Delgocitinib cream also met all key secondary outcome measures, including Investigator’s Global Assessment (IGA)-CHE treatment success, a reduction in HECSI scores from baseline to Week 24, and improvement in health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI).

Furthermore, patients receiving delgocitinib cream had fewer treatment-emergent adverse events (AEs) compared to those receiving alitretinoin capsules.

“The discussion of delgocitinib and the presentation of DELTA FORCE data in The Lancet is an exciting moment for the LEO Pharma team,” said Robert Spurr, EVP, LEO Pharma, North America and President, LEO Pharma, US. “We are proud to contribute to the overall understanding of moderate to severe chronic hand eczema, helping uncover potentially new treatment options for those living with skin conditions like CHE.”

“We know that CHE is an under researched condition,” commented Dr. Charles Lynde, Chief Medical Director, The Lynde Institute for Dermatology & Lynderm Research Inc. and Associate Professor, University of Toronto, Department of Medicine. “We hope that discussions of the DELTA FORCE program, like that published in The Lancet, will continue to raise awareness of the disease, inspire new research, and ultimately help improve the quality of life 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.³

About the DELTA FORCE Trial

DELTA FORCE was a 24-week, randomized, assessor-blinded, active-controlled, parallel-group, phase 3, two-arm trial to compare the efficacy and safety of delgocitinib cream twice-daily with alitretinoin capsules once-daily in adult participants with severe chronic hand eczema.¹

The primary endpoint of the trial was the change in Hand Eczema Severity Index (HECSI) score from baseline to Week 12. Participants assigned to receive delgocitinib cream applied the drug to the skin twice a day for 16 weeks. Participants assigned to receive alitretinoin capsules took the drug orally once a day for 12 weeks. All participants were permitted to continue for up to 24 weeks if the doctor considered that they were benefiting from the treatment.¹

All 14 North American DELTA FORCE clinical trial sites were located in Canada.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 prevalence rate of approximately 4.7%.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.²

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,⁹ 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.¹⁰ Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.¹¹

About delgocitinib cream

Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.¹² The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.¹³

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 cream for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights.

Delgocitinib cream is currently approved and marketed under the trade name Anzupgo® in the European Union, United Kingdom, Switzerland and the United Arab Emirates for the treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate. Delgocitinib is under investigation in Canada and the United States.

About LEO Pharma

LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit www.leo-pharma.com. LEO Pharma Canada is located in Toronto, Ontario.

References:

¹ ClinicalTrials.gov. National Library of Medicine (U.S.). A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema. Identifier: NCT05259722. https://classic.clinicaltrials.gov/ct2/show/NCT05259722.

² Thyssen JP, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis 2022;86:357–378.

³ The Lancet. About The Lancet. Published: 2024. Last assessed: Jun 25, 2024. Available at: https://www.thelancet.com/lancet/about.

⁴ Giménez-Arnau, Ana Maria et al. Efficacy and safety of topical delgocitinib cream versus oral alitretinoin capsules in adults with severe chronic hand eczema (DELTA FORCE): a 24-week, randomised, head-to-head, phase 3 trial The Lancet, April 16, 2025 Available at https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00001-7/abstract

⁵ 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.

⁶ 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.

⁷ 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.

⁸ Apfelbacher C, Bewley A, Molin S, et al. Prevalence of Chronic Hand Eczema in adults: A cross-sectional multi-national study of 60,000 respondents in the general population. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #3.

⁹ 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.

¹⁰ 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.

¹¹ 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.

¹² 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.

¹³ Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;32(3):e12840.

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