LEO Pharma announces positive outcome of DELTA 3 open-label extension trial of delgocitinib cream in the treatment of adults with moderate to severe chronic hand eczema (CHE)

LEO Pharma announces positive outcome of DELTA 3 open-label extension trial of delgocitinib cream in the treatment of adults with moderate to severe chronic hand eczema (CHE)

• Subjects who completed the 16-week twice-daily treatment regimen of delgocitinib cream or cream vehicle in the phase 3 DELTA 1 or DELTA 2 trials were offered to immediately enroll into the 36-week DELTA 3 extension trial.¹
• The DELTA 3 trial evaluated the long-term safety of twice-daily as needed treatment with delgocitinib cream for up to 36 weeks in adults with moderate to severe CHE.¹
• The long-term safety profile of delgocitinib cream was consistent with previous results from the DELTA 1 and 2 trials.
• Patients who entered the DELTA 3 trial after receiving delgocitinib cream in the DELTA 1 and DELTA 2 trials maintained similar levels of symptom relief and treatment success over an additional 36-week treatment regimen.

BALLERUP, Denmark, October 30, 2023 -- LEO Pharma A/S, a global leader in medical dermatology, today announced the positive outcome of the DELTA 3 trial. DELTA 3 is a phase 3, single-arm, open-label extension trial of delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, for the potential treatment of adults with moderate to severe chronic hand eczema (CHE).

In the DELTA 3 trial, the long-term safety of twice-daily as needed treatment with delgocitinib cream for up to 36 weeks in adults with moderate to severe CHE was evaluated.¹ The results showed that the long-term safety profile remained consistent with previous results from the DELTA 1 and 2 trials. Delgocitinib cream was generally well tolerated over the 36-week period.

All DELTA 3 trial subjects had completed the DELTA 1 or DELTA 2 trials and were offered to immediately enroll into this extension trial. This included patients treated with delgocitinib cream for the initial 16-week treatment period, as well as the patients who received cream vehicle.¹

Patients who entered the DELTA 3 trial after 16 weeks of twice-daily treatment with delgocitinib cream in the DELTA 1 and 2 trials maintained similar levels of symptom relief and treatment success over an additional 36-week treatment regimen.

Furthermore, patients who entered the DELTA 3 trial after receiving cream vehicle in the DELTA 1 and DELTA 2 trials reached similar levels of treatment success as the patients previously treated with delgocitinib cream.

"It is encouraging to see the level of consistency that these long-term results show, in line with the previous positive results from the pivotal DELTA 1 and 2 trials. This condition can have a negative impact on patient quality of life, physical functioning, and ability to work, and there are currently no topical treatments specifically approved for moderate to severe chronic hand eczema," said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. "We will continue our work to investigate delgocitinib cream as a potential topical treatment for patients affected by this hard-to-treat disease.”

Further analyses of the data set will be conducted to determine the full potential of delgocitinib cream in the treatment of adults with moderate to severe CHE. Detailed results from DELTA 3 are planned to be submitted for scientific presentation and publication at a later date.

For more information on the DELTA 3 trial (NCT04949841) 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) was 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 DELTA 1 and DELTA 2 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).

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.

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 enroll into the DELTA 3 extension trial. The purpose of this extension trial was to evaluate the long-term safety of twice-daily as needed treatment with delgocitinib cream. Subjects visited the clinic every 4 weeks to assess the safety and efficacy of the treatment, as well as its effect on patient-reported outcomes (PROs) until Week 36, with a final follow-up phone call planned on Week 38.¹

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.^4,5 HE is the most common skin disorder of the hands⁶ with a one-year prevalence rate of approximately 9%.⁷ In a substantial number of patients, HE can develop into a chronic disease.⁶ 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.⁸

About delgocitinib

Delgocitinib cream is an investigational, 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.⁹ The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.¹⁰ 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 4,700 people, serving millions of patients across the world. In 2022, the company generated net sales of DKK 10.6 billion.

Contacts

Jes Broe Frederiksen

LEO Pharma, Senior Manager, Product & Data Communications 

Tel: +45 53 60 59 48

Email: jebfe@leo-pharma.com   

Henrik Heskjær

LEO Pharma, Senior Media Advisor

Tel: +45 31406180

Email: hdtdk@leo-pharma.com

References

1. 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 (DELTA 3). Identifier: NCT04949841. https://clinicaltrials.gov/study/NCT04949841.
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/study/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. Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg. 2010;14(6):267-284.
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. 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.
7. 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.
8. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.
9. 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.
10. Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;32(3):e12840.

MAT-69414 October 2023