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LEO Pharma has announced positive top line results from its phase 3 study of delgocitinib cream in adults with moderate-to-severe chronic hand eczema (CHE).

Also referred to as dermatitis, hand eczema is the most common skin disorder of the hands and one of the most common types of eczema.

In patients with hand eczema, the skin is generally dry, scaly and thickened, and the fingers can become swollen when the eczema is flaring. Other symptoms may include cracking, soreness, bleeding and, in some cases, blisters may develop.

CHE, which affects a substantial number of patients, is defined as hand eczema that lasts for more than three months or relapses twice or more within a year.

“CHE is a condition that we know can have a hugely negative impact on patient quality of life, physical functioning and ability to work,” explained Jörg Möller, executive vice president, global research and development, LEO Pharma.

Delgocitinib is a topical pan-Janus kinase inhibitor that blocks activation of the JAK-STAT pathway, which plays a key role in the immune system in driving the pathophysiology of chronic inflammatory skin diseases.

The company’s DELTA 2 trial, which is the second of two pivotal phase 3 clinical trials with delgocitinib cream, met its primary endpoint of a statistically significant improvement in CHE after 16 weeks of treatment with delgocitinib cream compared to cream vehicle.

All or most of the signs and symptoms of CHE were cleared early in the treatment period for a significantly larger proportion of patients treated with delgocitinib cream compared to subjects treated with cream vehicle, the company reported.

The new data follows positive top line results from the DELTA 1 trial, announced in December last year, which also assessed delgocitinib cream in adults with moderate-to-severe CHE.

“It is incredibly exciting to see the level of consistency that our DELTA 2 results show in line with the positive DELTA 1 results announced late last year,” Möller said.

“These results bring us one step closer towards establishing delgocitinib as a best-in-class innovative topical treatment for patients affected by this hard-to-treat disease,” he added.

Patients who completed the 16 weeks of treatment in both trials were invited to join the DELTA 3 extension trial to evaluate the long-term effects of delgocitinib cream, the company said, with further analyses of the data set to be conducted to determine the full potential of delgocitinib cream in this patient population.