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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|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)|
- 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 ]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.
- The proportion of patients who achieve an improvement of 50% or greater from their baseline objective SCORAD at Week 12 of ILV-094 treatment. [ Time Frame: 12 weeks ]This analysis will be performed using fisher exact test. Patients who drop-out will be considered treatment failures (non-responder approach). A sensitivity analysis will be carried out using data as observed.
- The (per-patient) percent improvement in the SCORAD relative to baseline. [ Time Frame: 12 weeks ]The (per-patient) percent improvement in the SCORAD relative to baseline, which will be analyzed using the MMRM approach described for the primary efficacy endpoint.
- Measurement of treatment success in the static IGA score at week 12 as compared to baseline. [ Time Frame: 12 weeks ]Measurement of treatment success defined as a score of "clear-0" or "almost clear-1" in the static IGA score at week 12 as compared to baseline.
|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:||James Krueger, MD||The Rockefeller University|