Randomized Placebo Controlled Study to Determine Safety, Pharmacodynamics and Efficacy of ILV-094 in Atopic Dermatitis
This trial is active, not recruiting.
|Treatments||ilv-094, placebo comparator|
|Start date||October 2013|
|End date||October 2017|
|Trial size||60 participants|
|Trial identifier||NCT01941537, JKR-0766|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
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
Reversal of the pathological epidermal phenotype during ILV-094 therapy
time frame: 12 weeks
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria: - Male or females between the ages 18-75 year-old, with chronic disease (>6 months). - Have moderate to severe AD - Patients who fail or cannot sustain response with one or more of the three treatment categories listed below - Category 1 : Hydration plus topical steroids and/or antibiotics (tetracycline, bactrim, cephalosporins, etc) and or topical immune modulators (protopic/elidel). - Category 2: Systemic Steroids and/or Phototherapy. - Category 3: Cyclosporine and/or Other Immunomodulators (Methotrexate, CellCept, and Immuran). - Women of childbearing potential must test negative for pregnancy and agree to use birth control measures that are highly effective. - Are PPD negative at the time of screening. - Willingness to avoid alcohol intake 48 hours before each visit in which study drug will be received, in order to avoid increases in liver function tests (LFTs) (this was an exclusion in other ILV-094 studies in order to guard against increased LFTs due to alcohol intake being attributed to study drug). Exclusion Criteria: - History of active or latent serious infections (TB, or other granulomatous disorders such as histoplasmosis, coccidioidomycosis, etc). Skin colonization by Staph. aureus is expected in a high percentage of atopic patients with active disease and will not be considered as an exclusion criteria. - Have a known malignancy or history of malignancy (except for basal or squamous cell carcinoma completely excised without evidence of recurrence and treated carcinoma in situ of the cervix) or lymphoproliferative diseases - Have a nontuberculous mycobacterial infection or opportunistic systemic infection (e.g., Pneumocystis carinii, and aspergillosis) within 6 months prior to screening. - Have positive HIV by history or POCT on the screening visit. - Have documented current active hepatitis B (surface antigen positive or asymptomatic chronic carriers) or a history of hepatitis C infection (anti-HCV positive), by history and/or screening test. - Have a history of substance abuse (drug or alcohol) within the past year before screening. - Have a serious concomitant illness that could require the use of systemic corticosteroids or otherwise interfere with the patient's participation in the trial. - Pregnant women or women that are breast feeding or plan to breast feed. - Evidence of acute or unstable clinically significant disease or any unstable serious disorder requiring active frequent monitoring. - Evidence of other concomitant skin conditions (eg, psoriasis, or lupus erythematosus) other than atopic dermatitis that would interfere with evaluations of the effect of study medication on atopic dermatitis. - Use of any investigational small molecule drug within 90 days before the first dose of test article administration. - Have a transplanted organ (with the exception of a corneal transplant performed >3 months prior to screening). - Have concomitant autoimmune disease - Clinically important deviation from normal limits in physical examination, vital sign measurements, 12-lead electrocardiograms (ECGs), or clinical laboratory tests results, not associated with a chronic, well-controlled medical condition. Examples of these deviations include following: 1. Undiagnosed hypertension. 2. Evidence of undiagnosed ischemic heart disease or potentially clinically significant arrhythmia on ECG. 3. Hemoglobin <9 g/dl 4. WBC count < 3.5 x 109 cells/L 5. Neutrophils <1 x 109 cells/L 6. Platelets < 100 x 109 cells/L 7. AST/SGOT and ALT/SGPT levels above 2 times the upper limit of normal for the laboratory conducting the test. 8. Alkaline phosphatase levels above 2 times the upper limit of normal for the laboratory conducting the test. - Live vaccines within 3 months before test article administration or during the study.
|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)|
|Principal investigator||Emma Guttman, MD|
|Description||This is a randomized, double-blind, placebo-controlled, study of six IV infusions of ILV-094 administered to subjects with atopic dermatitis. Sixty subjects will be randomly assigned in a 2:1 ratio to one of the two treatments arms (ILV-094 vs placebo). Forty patients will be enrolled in the ILV-094 treatment arm and 20 in the placebo-treatment arm, accordingly. A loading IV dose of 600 mg of ILV-094 or placebo will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 or placebo every two weeks (Weeks 2, 4, 6, 8, and 10). We will continue to follow the patients every two weeks for an additional 10 weeks after the last IV dose (20 weeks post baseline).|
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