Leo takes topical JAK inhibitor into phase 3 eczema program

Leo Pharma CEO Catherine Mazzacco (Leo Pharma)

Leo Pharma has begun a phase 3 clinical trial of its topical pan-JAK inhibitor. The study will assess the ability of delgocitinib cream to improve outcomes in patients with moderate to severe chronic hand eczema. 

In recent years, biopharma companies have begun to show JAK inhibitors, which first came to market as treatments for diseases that manifest inside the body, have potential as treatments for disorders of the skin. Some companies are using the same oral routes of administration already used to treat diseases such as rheumatoid arthritis, but others are working on topical formulations.

Leo entered the topical JAK inhibitor space in 2014 when it licensed delgocitinib for use outside of Japan in dermatological indications. Having completed a phase 2b study last year, Leo is now pushing on into phase 3.

The two phase 3 studies, DELTA 1 and DELTA 2, are each set to enroll 450 moderate to severe chronic hand eczema patients and randomize them to use delgocitinib cream or a control twice a day for 16 weeks. The primary endpoint of both trials is the Investigator's Global Assessment for chronic hand eczema at Week 16.

Leo expects to complete the studies around the end of next year, according to ClinicalTrials.gov. The target means Leo faces the prospect of coming to market after other oral and topical JAK inhibitors—Incyte has already filed for FDA approval of its topical formulation of ruxolitinib—but its choice of patient population could lessen the impact of its late arrival.

The phase 3 delgocitinib trials are enrolling patients with hand eczema that has persisted for more than three months or returned twice or more within the last 12 months. Patients with eczema that requires medical treatment in parts of the body other than the hands and feet are excluded from the clinical trial.