This clinical trial will investigate the effectiveness and safety of a new active ingredient (LEO 138559) in the treatment of moderate to severe atopic dermatitis (AD). It is given by subcutaneous injection. Some people in the trial will instead receive Dupixent® which is an approved treatment for moderate to severe AD. Dupixent® is also given by subcutaneous injection. The main aim of this clinical trial is to investigate which changes in biomarkers in the skin are caused by LEO 138559 and Dupixent®. The trial includes a screening phase of up to 4 weeks, followed by a treatment period of 16 weeks, and a safety follow-up period of 16 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
13
LEO 138559 is an antibody given by subcutaneous injection.
Dupixent® is an antibody given by subcutaneous injection.
LEO Investigational Site
Vienna, Austria
Change in Gene Expression Typically Associated With Atopic Dermatitis in Lesional Skin Biopsies From Baseline to Week 4
Lesional skin biopsies will be evaluated by single cell RNA sequencing to evaluate global gene expression
Time frame: From baseline to week 4
Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject
Time frame: Between baseline and week 16
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