Atopic Dermatitis Clinical Trial
Official title:
A Randomized Placebo-controlled Study to Determine the Safety, Tolerability, Pharmacodynamics and Clinical Efficacy of ILV-094 (an IL-22 Antibody) Administered Intravenously to Subjects With Atopic Dermatitis (AD)
Atopic dermatitis (AD) is a common inflammatory skin disorder that adversely affects most
aspects of everyday life in majority of patients. It has a prevalence of up to 3-4% of adults
and up to 25% among children. AD has a complex pathogenesis, characterized by: 1) immune
activation with increased numbers of T-cells, dendritic cells (DCs), and increased expression
of inflammatory molecules 2) marked epidermal hyperplasia in chronic diseased skin, and 3)
defective barrier function with increased trans-epidermal water loss (TEWL) and decreased
lipids, reflecting underlying alterations in keratinocyte differentiation. AD is
predominantly a Th2 (IL-4, IL-13, and IL-31) disease, and recently was also found to be a
"T22" (IL-22) polarized disease.
ILV-094 is an anti IL-22 antibody and therefore should reverse the immune activation of AD.
This study is being done to assess the safety, tolerability, clinical efficacy, and mechanism
of action of ILV-094 in patients with AD.
This is a randomized, double-blind, placebo-controlled, study of six IV infusions of ILV-094 administered to subjects with atopic dermatitis. Sixty subjects will be randomly assigned in a 2:1 ratio to one of the two treatments arms (ILV-094 vs placebo). Forty patients will be enrolled in the ILV-094 treatment arm and 20 in the placebo-treatment arm, accordingly. A loading IV dose of 600 mg of ILV-094 or placebo will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 or placebo every two weeks (Weeks 2, 4, 6, 8, and 10). We will continue to follow the patients every two weeks for an additional 10 weeks after the last IV dose (20 weeks post baseline). ;
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