Randomized Placebo Controlled Study to Determine Safety, Pharmacodynamics and Efficacy of ILV-094 in Atopic Dermatitis

Exclusion Criteria

• •\*Patients with a history of a positive PPD that have received prophylaxis will be permitted to enroll into the study.
• •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 such as including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (e.g. nodes in the posterior triangle of the neck, intraclavicular, epitrochlear or periaortic areas) or splenomegaly.
• •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 (eg, unstable cardiovascular, cerebrovascular, respiratory, renal, or psychiatric 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.
• •Have shown a previous immediate hypersensitivity response, including anaphylaxis, to an immunoglobulin product (plasma-derived, recombinant, e.g. monoclonal antibody).
• •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 (such as lupus, rheumatoid arthritis, multiple sclerosis, Crohn's Disease, etc).
• •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.
• •Any medical, psychological or social condition that, in the opinion of the investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.