Randomized Placebo-controlled Study of ISA247 in Plaque Psoriasis

Exclusion Criteria

• •Has generalized erythrodermic, guttate, or pustular psoriasis.
• •Have other dermatoses that would interfere with the evaluation of psoriasis, at the discretion of the investigator.
• •A current malignancy or history of malignancy within 5 years or a history of lymphoma at any time. Subjects can be enrolled with a history of squamous or basal cell carcinoma that has been surgically excised or removed with curettage and electrodesiccation.
• •Has current, uncontrolled bacterial, viral, or fungal infections that require intravenous antibiotics or antifungals or had had such infections within 60 days prior to screening.
• •A history of streptococcal infection that required oral antibiotics within 30 days prior to screening.
• •A known history of tuberculosis.
• •Serologic evidence or known latent human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) virus.
• •Uncontrolled hypertension as defined by systolic blood pressure ≥150 mm Hg or diastolic blood pressure ≥ 90 mm Hg.
• •MDRD GFR ≤ 60 ml/min.
• •Variation between the screening and Visit 1 GFR ≥30%.
• •Alanine transaminase, aspartate transaminase, or gamma-glutamyl transferase ≥ 3x upper limit of normal (ULN).
• •White blood cell count ≤ 2.8 x 109/L.
• •Triglycerides ≥ 3x ULN.
• •Requires the following prohibited medications or treatments during the washout or treatment period: drugs potentiating the nephrotoxicity of voclosporin such as NSAID's or ACE inhibitors, drugs interfering with its pharmacokinetics; drugs considered to contribute to psoriasis flare; or, systemic and topical psoriasis medication (including psoralen/ultraviolet A light treatment) that may interfere with assessment of study drug efficacy.
• •Has used any investigational drug or device within 28 days or 5 half lives (whichever is longer) prior to the screening visit.
• •Has taken biological agent(s), except flu shots, tetanus shots, or boosters, within 3 months of the start of treatment. Biological agents include any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment, or cure of diseases or injuries of man.
• •Previous exposure to voclosporin.
• •A history of clinically defined allergy to cyclosporine or any of the constituents of the voclosporin formulation (vitamin E, medium chain triglyceride oil, Tween 40, ethanol).
• •A history of alcoholism or drug addiction within 1 year prior to study entry.
• •Weighs \<45 kg (99 lbs) or \> 140 kg (308 lbs).
• •A history of disease, including mental/emotional disorder that would interfere with the subject's participation in the study, or that might cause the administration of ISA247 to pose a significant risk to the subject, in the opinion of the investigator.