Study Validates Long-Term Safety of Delgocitinib Cream in Adults With Chronic Hand Eczema

10/30/2023

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.

LEO Pharma’s Delgocitinib Cream was well-tolerated in adults with moderate to severe chronic hand eczema (CHE), according to results from the DELTA 3 Open-Label Extension Trial.

What’s more, 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.

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.

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. 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.

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. This included patients treated with delgocitinib cream for the initial 16-week treatment period, as well as the patients who received cream vehicle. 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, the study showed.

"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," says Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma, in a news release. "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.

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