Study to Assess VB-201 in Patients With Psoriasis

A Randomized, Double-Blind, 12-Week, Dose-Ranging Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients With Moderate to Severe Plaque Psoriasis

The purpose of this study is to examine the efficacy, safety and tolerability of VB-201 as compared with placebo on measures of disease activity in patients with psoriasis.

Inclusion Criteria:

• Male or female Patients, ≥18 to ≤75 years of age, who have a diagnosis of chronic plaque psoriasis for at least 6 months
• Non-anorexic subjects with a BMI ≥20
• Psoriasis Area and Severity Index (PASI) score of ≥12
• Plaque psoriasis covering ≥10% of body surface area (BSA)
• Psoriasis severity at least moderate, scoring at least 3 on the 0 to 5 point Physician Global Assessment (PGA) scale

Exclusion Criteria:

• The subject presents with the predominant type of psoriasis as guttate, erythrodermic, inverse, pustular or palmo-plantar or an unstable form of psoriasis
• The subject has not undergone wash-out periods of sufficient duration for the following treatments at Baseline: Topical psoriasis treatments; Systemic, oral or injected, psoriasis treatments; Phototherapy
• The subject anticipates getting enough ultra-violet light during the study to cause psoriasis to improve
• The subject has a known allergy or sensitivity to the study treatment(s) or to any of the excipients contained in the study drug formulation
• History of cancer, the exception is skin cancer
• Has a clinically significant systemic infection within 30 days of Day 0, or a history or presence of recurrent or chronic infection
• Evidence of tuberculosis as indicated by a positive tuberculin skin test or a quantiferon test in subjects known to have a + PPD and a negative chest x-ray at screening
• History of clinically significant hypoglycemia
• Subjects with currently active peptic ulcer / gastroesophageal reflux disease