Study to Assess VB-201 in Patients With Psoriasis

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics

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