Vascular Inflammation in Psoriasis - Extension Study

Exclusion Criteria

• •1. Previous adverse event following exposure to a TNF-alpha antagonist that led to discontinuation of the TNF inhibitor and contraindicates future treatment.
• •2. Previous lack of response to a TNF-alpha antagonist led to discontinuation.
• •3. Diagnosis of erythrodermic psoriasis, generalized pustular psoriasis, or medication-induced or medication-exacerbated psoriasis.
• •4. Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.
• •5. Subject is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed.
• •6. Poorly controlled medical condition, such as unstable ischemic heart disease, congestive heart failure, recent cerebrovascular accidents, psychiatric disease requiring frequent hospitalization, and any other condition, which, in the opinion of the Investigator, would put the subject at risk by participation in the study.
• •7. History of diabetes mellitus, type 1 or type 2 (patients with type 2 diabetes may be enrolled if the duration of diabetes is \<10 years and HbA1c is \<7.0%)
• •8. Uncontrolled hypertension, with measured systolic blood pressure \>180 mmHg or diastolic blood pressure \>90 mmHg
• •9. History of demyelinating diseases or lupus.
• •10. Subject has infection or risk factors for severe infections, for example:
• •* Known history of HIV, hepatitis B or C, or other severe, recurrent, or persistent infections;
• •* Excessive immunosuppression or other factors associated with it, including human immunodeficiency virus infection;
• •* Active tuberculosis (TB) disease;
• •* Evidence of latent TB infection demonstrated by Purified Protein Derivative (PPD) ≥ 5 mm of induration or positive Quantiferon-GOLD results as determined within 6 months of the baseline visit for VIP-E; except if prophylactic treatment for TB, as recommended by local guidelines, is initiated prior to administration of study drug or if there is documentation that the subject has received prophylactic treatment for TB previously.
• •* Any other significant infection requiring hospitalization or intravenous (IV) antibiotics in the month prior to Baseline;
• •* Infection requiring treatment with oral or parenteral antibiotics within 14 days prior to Baseline;
• •* Subject will require a live vaccination during study participation including up to 30 days after the last dose of study drug.
• •11. Subject has history of hematological or solid malignancy within the past five years other than successfully treated basal cell carcinoma, non-metastatic cutaneous squamous cell carcinoma or cervical carcinoma in situ.
• •12. Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study.
• •13. Clinic laboratory analyses showing any of the following abnormal results:
• •* Hemoglobin (Hgb) \< 10 g/dL in females or \<12 g/dL in males;
• •* White blood cell (WBC) count \<2.5 x 109/L
• •* Subject can be included if WBC count is \<2.5 x x 109/L and absolute neutrophil count (ANC) is \>1000 cells / mm3.
• •* WBC count \> 15 x 109/L;
• •* Platelet count \< 100 x 109/L;
• •* Serum aspartate transaminase (AST) or alanine transaminase (ALT) \>2.5 upper limits of normal (ULN);
• •* Serum total bilirubin ≥2 mg/dL (≥26 µmol/L)
• •14. Recent history of substance abuse or psychiatric illness that could preclude compliance with the protocol.
• •15. If subject is on cholesterol-lowering medication (e.g. statin), dose and form of medication must be stable for 90 days prior to baseline and remain stable throughout the duration of the study.