LEO Pharma A/S, a global leader in medical dermatology, announced  the initiation of the phase 3 DELTA CARE 1 trial. The trial aims to evaluate the efficacy and safety of delgocitinib cream compared to cream vehicle for the treatment of adults with mild to severe lichen sclerosus (LS).¹

"By investigating the expansion of the indication for delgocitinib, LEO Pharma is taking another important step toward addressing high unmet needs in medical dermatology, while advancing our ambition to lead research in delgocitinib for dermatological diseases and supporting future growth," said Sophie Lamle, Executive Vice President, Development, LEO Pharma. "There are currently no approved treatments in the U.S. or in Europe specifically for LS – a disease with a high burden on quality of life. We are committed to developing innovative solutions that can make a fundamental difference in their lives, and we are excited to further explore the potential of delgocitinib in this burdensome disease.”

Anzupgo is currently approved in the U.S., the EU, and several other markets for adult patients with moderate to severe chronic hand eczema (CHE)^4,5. LEO Pharma is now investigating LS and exploring additional disease areas, where delgocitinib could address significant unmet medical needs.

LS is an inflammatory skin disease that typically affects the anogenital area where it can cause itching, soreness, architectural changes and scarring, with a significant impact on the quality of life of affected patients.⁵ LS may lead to sexual and urinary dysfunction in both women and men.⁵

"Persistent itching, soreness, and the risk of permanent scarring can severely affect quality of life, particularly for women, where LS is far more prevalent," said Jacob Thyssen, Executive Vice President, Chief Scientific Officer, LEO Pharma. "The currently no approved treatments specifically indicated for LS is leaving many patients with limited options and highlighting the need for new therapies."

Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor shown to inhibit the activity of all four JAKs, which are involved in inflammatory signaling.^2,3 This trial will be the first to investigate the potential beneficial effects of a pan-JAK inhibitor for the treatment of LS.

The DELTA CARE 1 trial plans to recruit up to 652 adult patients with LS, beginning with the recruitment of 300 female patients to investigate the optimal dose. The selected dose will then be evaluated against cream vehicle in up to 352 additional female and male participants.¹ Participants will be recruited across 80-90 sites in the United States, Canada, the UK, Germany, Frace, Italy, Spain and Poland.