BALLERUP, Denmark, February 27, 2025 --- LEO Pharma A/S, a global leader in medical dermatology, today announced the positive results for the primary endpoint from the double-blind treatment period of the DELTA China trial. DELTA China is a phase 3 clinical trial with Anzupgo® (delgocitinib) 20mg/g cream, a topical pan-Janus kinase (JAK) inhibitor, for the potential treatment of Chinese adults and adolescents (aged 12 and above) with moderate to severe Chronic Hand Eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.¹

 

The phase 3 trial consists of a 16-week randomized, double-blind, vehicle-controlled, treatment period, followed by an open-label treatment period of 36 weeks.¹ A total of 362 subjects were recruited and randomized in a 2:1 ratio to receive either Anzupgo or cream vehicle.¹

 

The results announced today cover the double-blind treatment period of the DELTA China trial from Week 0 to Week 16 of Anzupgo treatment and are an important milestone in the Chinese market as there are currently no approved treatment options specifically indicated for moderate to severe CHE in China.¹ The primary endpoint for DELTA China was the Investigator’s Global Assessment for Chronic Hand Eczema Score (IGA-CHE TS) at Week 16, which was met with a statistically significant improvement in CHE severity after 16 weeks of treatment with Anzupgo compared to cream vehicle.¹

 

Furthermore, the 16-week safety profile of Anzupgo was consistent with previous pivotal trials, and the pharmacokinetics (PK) data supported low systemic exposure.¹

 

The open-label treatment period of the DELTA China trial runs from Week 16 to Week 52 and is still ongoing.¹ The results from this stage of the trial will be released at a later date.

 

The primary objective of the study was to evaluate the efficacy of twice-daily applications of Anzupgo compared with cream vehicle in the treatment of Chinese subjects with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate.¹

 

“Following the results from DELTA China, including the consistent safety profile and pharmacokinetics data, we will continue our work to investigate delgocitinib cream as a potential treatment option for patients living with moderate to severe CHE, as there are currently no approved treatments specifically for CHE available here in China,” said Byron Yin, General Manager for LEO Pharma in China. “LEO Pharma has a unique heritage for innovative topicals, and I look forward to seeing the full data set, which I hope will set us up for further advances and ultimately help us to introduce this new treatment option in China.”

 

The DELTA China trial was structured in line with the DELTA 1 and 2 phase 3 trials investigating CHE in Europe and Canada, which both met all primary and secondary endpoints.^2-5

 

“DELTA China demonstrates LEO Pharma’s truly global approach when it comes to addressing the unmet needs of patients living with moderate to severe CHE worldwide,” said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. “Skin conditions are not specific to borders and nor is our commitment to research. The results from this phase 3 trial in the Chinese population builds upon our expanding collection of scientific data for treating moderate to severe CHE globally. Our work will continue to advance the standard of care for this debilitating condition.”

 

Currently, Anzupgo is approved for adults in the European Union, United Kingdom, Switzerland, and the United Arab Emirates for the treatment of moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate, and is under investigation in other markets, including the United States.

 

Detailed results from DELTA China are planned to be submitted for scientific presentation and publication at a later date.

 

For more information on the DELTA China trial (NCT06004050) go to clinicaltrials.gov.

 

*ENDS*

 

About Anzupgo® (delgocitinib) cream

Anzupgo is currently approved 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. Anzupgo is under investigation in other markets, including the United States.

 

Anzupgo® (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.⁶ The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.⁷

 

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.

 

About the DELTA China Trial

DELTA China is a phase 3 trial to evaluate efficacy, safety, and pharmacokinetics (PK) (only adults) of twice-daily applications of Anzupgo in Chinese adults and adolescents (aged 12 and above) with moderate to severe CHE.¹

 

The primary endpoint of the DELTA China trial was the Investigator’s Global Assessment for CHE 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.¹

 

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.^8,9 HE is the most common skin disorder of the hands10 with a prevalence rate of approximately 4.7%.¹¹ In a substantial number of patients, HE can develop into a chronic condition.¹⁰ 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.¹²

 

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,¹³ 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.¹⁴ Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.¹⁵

 

References

1. ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy, Safety, and Pharmacokinetics of Delgocitinib Cream in Chinese Adults and Adolescents With Moderate to Severe Chronic Hand Eczema. Identifier: NCT06004050. https://clinicaltrials.gov/study/NCT06004050.
2. 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/NCT04871711.
3. 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.
4. 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;404(10451):461-473. doi:10.1016/S0140-6736(24)01027-4.
5. 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.
6. 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.
7. Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;32(3):e12840.
8. 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.
9. 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.
10. 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.
11. 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.
12. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.
13. 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.
14. 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.
15. 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.

 

MAT- 80047 February 2025