Active Digestion, Kidneys & Other Organs NIHR-supported project Cancer

A Phase 3, randomized, double-blind, placebo-controlled,parallel-group study to investigate the efficacy and safety ofdupilumab for the treatment of pruritus of Lichen SimplexChronicus (LSC) in adults

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A new clinical trial will test whether the drug dupilumab can relieve the severe itching of Lichen Simplex Chronicus (LSC), a skin condition that drives people to scratch until their skin thickens into dark, leathery patches. LSC is notoriously difficult to treat. Existing creams and medications often fail or cause unpleasant side effects, leaving many patients with relentless itching that disrupts sleep, work, and daily life. The condition commonly affects the neck, ankles, scalp, and genitals, and the scratching itself worsens the skin damage. Dupilumab already reduces itching in other skin diseases like eczema, so researchers want to see if it works for LSC as well. This phase 3 trial is double-blind and placebo-controlled, meaning neither patients nor doctors will know who receives the real drug. Running across 17 countries and starting in November 2024, each participant will be followed for up to 10 months. If dupilumab proves effective, it could become the first targeted treatment for LSC—offering a safe, reliable option for a condition that currently has none. That would directly improve quality of life for thousands of adults who currently cycle through ineffective therapies.

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How effective and safe dupilumab (study medicine) is compared to a placebo (dummy treatment) in adult participants with Lichen Simplex Chronicus (LSC). The study will take place in 17 countries, and it is planned to start in November 2024. LSC causes severe itching and scratching of the skin. It results in one or several thickened, pink to dark-brown skin areas, commonly affecting the neck, ankles, scalp, anus, genitals, hands and/or feet. LSC is difficult to treat and can disrupt a person’s daily life. Available treatments are not always effective and may cause unpleasant side-effects. Since dupilumab is effective in decreasing the itching in other skin diseases, the researchers want to test if it can decrease the itching associated with LSC. The study is double-blind (neither the people taking part, nor the study doctors know who is given medicine or placebo), placebo-controlled, 2-arm study where each person participates for up to 10 months. The placebo looks like the medicine being tested, but it does not have any real medicine hence “dummy medicine”. The treatment (dupilumab or placebo) is randomly chosen for each

Researchers

Michael Ardern-Jones (Principal Investigator)

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