Delgocitinib cream (Anzupgo, LEO Pharma) met its primary endpoint in the Phase 3 DELTA China Trial of Chinese patients with moderate-to-severe chronic hand eczema (CHE).
The primary endpoint for DELTA China was the Investigator’s Global Assessment for Chronic Hand Eczema Score (IGA-CHE TS) at Week 16, which was met with a statistically significant improvement in CHE severity after 16 weeks of treatment with delgocitinib cream compared to cream vehicle.
DELTA China is a phase 3 clinical trial with delgocitinib 20mg/g cream, a topical pan-Janus kinase (JAK) inhibitor, for the potential treatment of Chinese adults and adolescents (aged 12 and above) with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate. The phase 3 trial consists of a 16-week randomized, double-blind, vehicle-controlled, treatment period, followed by an open-label treatment period of 36 weeks. A total of 362 subjects were recruited and randomized in a 2:1 ratio to receive either Anzupgo or cream vehicle.
The new results cover the double-blind treatment period of the DELTA China trial from Week 0 to Week 16 of delgocitinib creamtreatment. There are currently no approved treatment options specifically indicated for moderate-to-severe CHE in China. The 16-week safety profile of delgocitinib cream was consistent with previous pivotal trials, and the pharmacokinetics (PK) data supported low systemic exposure.
The open-label treatment period of the DELTA China trial runs from Week 16 to Week 52 and is still ongoing. The results from this stage of the trial will be released at a later date.
The DELTA China trial was structured in line with the DELTA 1 and 2 phase 3 trials investigating CHE in Europe and Canada, which both met all primary and secondary endpoints.
Currently, delgocitinib cream is approved for adults in the European Union, United Kingdom, Switzerland, and the United Arab Emirates for the treatment of moderate-to-severe CHE for whom topical corticosteroids are inadequate or inappropriate, and is under investigation in other markets, including the United States. Detailed results from DELTA China are planned to be submitted for scientific presentation and publication at a later date.
