Danish pharmaceutical company LEO Pharma A/S said on Wednesday that it has initiated the phase 3 DELTA CARE 1 trial to evaluate the efficacy and safety of Anzupgo (delgocitinib) cream versus cream vehicle in adults with mild to severe lichen sclerosus (LS).

LS is an inflammatory skin disease that typically affects the anogenital area, causing itching, soreness, architectural changes and scarring, with a significant impact on quality of life. LS may lead to sexual and urinary dysfunction in both women and men. There are currently no approved treatments specifically indicated for LS in the United States or in Europe.

The study is planned to enrol up to 652 patients, beginning with 300 female participants to determine the optimal dose, followed by evaluation in up to 352 additional female and male patients. Recruitment will take place across 80-90 sites in the United States, Canada, the UK, Germany, France, Italy, Spain, and Poland.

This trial supports LEO Pharma's strategy to expand Anzupgo beyond its current approval for moderate to severe chronic hand eczema in the United States, European Union, and other markets.

Delgocitinib cream is a topical pan-JAK inhibitor that blocks all four Janus kinases involved in inflammatory signalling, positioning it as a potential option for a skin disease with significant unmet medical need.