Randomized Placebo Controlled Study to Determine Safety, Pharmacodynamics and Efficacy of ILV-094 in Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT01941537|
Recruitment Status : Completed
First Posted : September 13, 2013
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: ILV-094 Drug: Placebo Comparator||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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)|
|Actual Study Start Date :||October 2013|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||January 2019|
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
- Percentage Change in SCORAD [ Time Frame: 12 weeks ]
Percentage Change in the Scoring of Atopic Dermatitis (SCORAD) at week 12 compared to baseline in both arms of the study in subjects with atopic dermatitis.
SCORAD (Severity scoring of Atopic Dermatitis) is composite severity index comprising a) the amount/extent of body surface area affected, b) subjective symptom visual analog assessments [itchy 0 (no itching) to 3 (severe itching) and sleep disturbance 0(no sleep disturbance) to 3 (severe sleep disturbance)], and c) 6 disease intensity assessments [dryness/scaling, erythema, induration/papulation, excoriation, lichenification and oozing/weeping/crusting, each graded from 0 to (none) to 3 (severe). A SCORAD score ranges from 0 (no AD present) to 103 (severe).
- The Percentage 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 ]The SCORAD50 captures individuals who achieved 50% or greater improvement from baseline SCORAD score. This outcome measure is the percentage of participants who achieved SCORAD50 at week 12. 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. Improvement is measured as the reduction in the score.
- Change in IGA Score [ Time Frame: 12 weeks ]
Change in Investigator Global Assessment score (IGA) at week 12 as compared to baseline for both arms of the study in subjects with atopic dermatitis.
IGA is a score between 0-5, with 0 being all clear, 1 being almost clear, 2 being mild disease, 3 being moderate disease, 4 being severe disease and 5 being very severe disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941537
|United States, New York|
|The Rockefeller University|
|New York, New York, United States, 10065|
|Principal Investigator:||James Krueger, MD||The Rockefeller University|