Randomized Placebo Controlled Study to Determine Safety, Pharmacodynamics and Efficacy of ILV-094 in Atopic Dermatitis
Status:
Completed
Trial end date:
2019-01-01
Target enrollment:
Participant gender:
Summary
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.