Randomized Placebo Controlled Study to Determine Safety, Pharmacodynamics and Efficacy of ILV-094 in Atopic Dermatitis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Phase II Study to Determine the Safety, Tolerability, Pharmacodynamics and Clinical Efficacy of ILV-094 (an IL-22 Antibody) in Subjects With Atopic Dermatitis (AD)|
- To assess the clinical benefit as measured by SCORAD (Scoring of AD) of intravenous (IV) administration of ILV-094 administered to subjects with atopic dermatitis (AD). [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]To assess the clinical benefit, safety and tolerability of intravenous (IV) administration of ILV-094 administered to subjects with atopic dermatitis (AD). The clinical effects on AD disease activity will be evaluated by the change in the Scoring of AD (SCORAD) index and investigator's global assessment (IGA) index of AD at week 12.
- Reversal of the pathological epidermal phenotype during ILV-094 therapy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Reversal of the pathological epidermal phenotype during ILV-094 therapy, and which immune pathways are suppressed during treatment with the drug.
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||October 2017|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
Forty patients will be enrolled in the ILV-094 treatment arm. A loading IV dose of 600 mg of ILV-094 will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 every two weeks (Weeks 2, 4, 6, 8, and 10).
IV infusion of ILV-094
Placebo Comparator: Placebo comparator
Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10).
Drug: Placebo Comparator
Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of a placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10).
Other Name: Placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT01941537
|United States, New York|
|The Rockefeller University|
|New York, New York, United States, 10065|
|Principal Investigator:||Emma Guttman, MD||The Rockefeller University|