LEO Pharma has announced a phase 3 trial of delgocitinib cream to treat adults with mild to severe lichen sclerosus (LS).
The DELTA CARE 1 trial will initially recruit 300 women, followed by a further 352 men and women, from 80-90 global sites in the US, Canada, the UK, Germany, Frace, Italy, Spain and Poland.
LS is a chronic, inflammatory skin condition that occurs more commonly in women than men. For women, it often appears in childhood before puberty and again around or after menopause, while for men it often appears in young adulthood or after the age of 60.
Symptoms include white patches of skin, itching, soreness and scarring, which can lead to sexual and urinary dysfunction in both women and men – all of which can affect patients’ quality of life, impacting daily activities and emotional well-being.
Jacob Thyssen, Executive Vice President, Chief Scientific Officer, LEO Pharma, said: “Persistent itching, soreness and the risk of permanent scarring can severely affect quality of life, particularly for women, where LS is far more prevalent.
“With no currently approved treatments specifically indicated for LS, [this] leaves many patients with limited options and highlights the need for new therapies.”
Anzupgo is currently approved in the US, the EU and several other markets for adult patients with moderate to severe chronic hand eczema (CHE). LEO Pharma is now investigating LS and exploring additional disease areas, where delgocitinib could address significant unmet medical needs.
Sophie Lamle, Executive VP, Development at LEO Pharma said: “There are currently no approved treatments in the US 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.”