drugset / Trial / NCT03983460

Dupilumab Impact on Skin Resident Memory T Cells

NCT03983460

RandomizedParallel-groupOpen-labelBasic science

Summary

The main objective of the study consists in characterizing the immune cells that are present/persist in the skin and the blood of atopic dermatitis (AD) patients treated with Dupilumab, as well as with potent/very potent topical corticosteroids (TCS: betamethasone valerate cream 0.1% or clobetasol propionate cream 0.05%). A specific attention will be paid on the presence/persistence of skin Trm and ILCs. The study population will consist of 20 adult patients suffering from moderate to severe Atopic Dermatitis and eligible for Dupilumab treatment. (Patients should have inadequate response, intolerance or contraindication to systemic anti-inflammatory treatments). This is an exploratory, prospective, single-site, randomized, open labeled study. There is a treatment period of 168 days (24 weeks) and a post-treatment follow-up period of maximum 102 days.

Timeline

Start
2020-03-09
Primary completion
2021-06
Completion
2021-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Dupilumab Monoclonal antibody 300 mg Subcutaneous
Comparator betamethasone valerate Small molecule 0.1 % Topical
Comparator clobetasol propionate Small molecule 0.05 % Topical

Indications