Last updated on January 2014

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)


Brief description of study

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)

Detailed Study Description

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. An epidermal barrier defect in AD was lately strongly associated with a mutation in a major epidermal differientation protein filaggrin (in 1 q21 locus) although broad down regulation of multiple terminal differientation genes (such as loricrin and corneodesmosin) were recently found to potentially conribute to the barrier dysfunction.

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. We also hope to provide additional support to the ILV-094 treatment proposal by studying the skin microbiome throughout treatment with the study drug.

Patients will be randomized to receive study drug or placebo (2:1 ratio) IV every 2 weeks for a total of 6 doses, with follow-up for a total of 10 weeks after the lat dose. Prior to initiation of study drug or placebo patients will be screened with physical exam, labs, ECG, chest x-ray to determine that they are in good health. Study activities throughout consist of safety labs, research labs, skin biopsies, skin swabs to analyze the skin microbiome, clinical assessments, clinical photography, physical exams, and adverse event assessment.

This study will be completed at 2 institutions, Rockefeller University (17 patients) and Mt Sinai School of Medicine (34 patients), 51 patient in total. Dr Lebwohl will be a co-PI on the NIH grant to fund the study and will be the responsible investigator at Mt Sinai School of Medicine for coordinating care of patients at that institution.All research tests on biopsy or blood tissue will be done at Rockefeller. However, IGE levels will be measured by the Mt Sinai Clinical Laboratory as a contracted test for this study. Standard safety blood tests will be done at each institution. The skin microbiome analysis will be done upon conclusion of the study if ILV-094 proves to be of benefit in atopic dermatitis. In the meantime samples will be archived and stored at Rockefeller University.

Clinical Study Identifier: TX137537

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The Rockefeller University Hospital

The Rockefeller University Hospital
New York, NY USA
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