Study to Assess VB-201 in Patients With Psoriasis

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Active Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: VB-201
* Drug: VB-201
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VB-201 20 mg<br> | Drug: VB-201<br>* Single daily dose of oral VB-201 20 mg<br>|
| Experimental: VB-201 80 mg<br> | Drug: VB-201<br>* Single daily dose or oral VB-201 80 mg<br>|
| Placebo Comparator: Placebo<br>Single daily dose of oral placebo | Other: Placebo<br>* Single daily dose of oral placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12 |  | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PGA (Physician Global Assessment) scores from baseline to Week 12 |  | 20 weeks | 
| Change in Patient Psoriasis Global Assessment scores from baseline to Week 12 |  | 20 weeks | 
| Change in affected Body Surface Area (BSA) from baseline to Week 12 |  | 20 weeks | 
| Measurement of improvement in the PASI (50) from baseline at Week 12 |  | 20 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis