LEO Pharma Announces Positive Results for Delgocitinib Cream for Chronic Hand Eczema

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Danish pharmaceutical company LEO Pharma announced in a press release positive results from the DELTA 3 open-label extension trial of delgocitinib cream (NCT04949841).

Delgocitinib cream is an investigational potential first-in-class topical pan-Janus kinase inhibitor in development for treating moderate to severe chronic hand eczema in adults. The DELTA 3 trial is an open-label extension study of the phase 3 DELTA 1 and DELTA 2 studies.

The DELTA 3 trial evaluated the long-term safety of delgocitinib cream applied twice daily as needed for up to 36 weeks in adults with moderate to severe chronic hand eczema. All participants of the DELTA 1 and DELTA 2 trials were offered enrollment in the DELTA 3 trial immediately after completion of the 16-week phase 3 studies. This included patients who received delgocitinib and those who received vehicle in the DELTA 1 and 2 trials.¹

The DELTA 3 study showed that delgocitinib cream was well tolerated after 36 weeks of treatment, consistent with previous safety results of the DELTA 1 and 2 trials. Furthermore, participants in the DELTA 3 trial maintained previous levels of symptom relief over the additional 36 weeks of treatment as they did during the first 16 weeks of the trial.

“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," Kreesten Meldgaard Madsen, chief development officer at LEO Pharma, said in a press release.

"We will continue our work to investigate delgocitinib cream as a potential topical treatment for patients affected by this hard-to-treat disease.”

Chronic hand eczema is a pruritic, inflammatory, and often painful, non-infectious skin disorder of the hands and wrists that persists for 3 months or more, or recurs at least twice per year.^2-5 Symptoms can include itching, dryness, stinging, burning, and pain in the affected areas. Some patients may experience more severe symptoms, such as scaling, fissures, and thickening of the skin on the hands and wrists.

References

1. 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. News release. October 30, 2023. Accessed November 2, 2023. https://www.leo-pharma.com/media-center/news/2023-leo-pharma-announces-positive-outcome-of-delta-3

2. Lynde C, Guenther L, Diepgen TL et al. Canadian Hand Dermatitis Management Guidelines. Journal of cutaneous medicine and surgery 2010; 14: 267-84.

3. Menné T, Johansen JD, Sommerlund M et al. Hand eczema guidelines based on the Danish guidelines for the diagnosis and treatment of hand eczema. Contact dermatitis 2011; 65: 3-12.

4. Lee GR, Maarouf M, Hendricks AK et al. Current and emerging therapies for hand eczema. Dermatol Ther 2019; 32: e12840.

5. Diepgen TL, Andersen KE, Chosidow O et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges 2015; 13: e1-22.

[This article was originally published by our sister brand, Managed Healthcare Executive.]