EFC18366
Research type
Research Study
Full title
A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of dupilumab for the treatment of pruritus of Lichen Simplex Chronicus (LSC) in adults
IRAS ID
1010733
Contact name
Patrick Maury
Contact email
Sponsor organisation
Aventis Pharma Limited, trading as Sanofi
Eudract number
2024-514762-39
Research summary
This study compares 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 participant meaning determined by chance using a computer program. Dupilumab is injected under the skin and people will receive 1 injection of dupilumab or placebo every 2 weeks, for a period of 24 weeks.
The benefits of dupilumab are currently not known. The study wants to test whether it can help people with LSC. Participants who received the study treatment across all studies with dupilumab had mild to moderate side effects, including but not limited to irritation at the injection site (redness, swelling, itching and pain) and eye problems (redness and itching).
In this study, a placebo is used to better see the effect of the medicine being tested, compared with having no medicine.REC name
Wales REC 2
REC reference
24/WA/0265
Date of REC Opinion
5 Nov 2024
REC opinion
Further Information Favourable Opinion