Study to Assess VB-201 in Patients With Psoriasis

VBL Therapeutics

Status and phase: Completed; Phase 2

Conditions: Active Plaque Psoriasis

Treatments: Drug: VB-201; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01001468

VB-201-006

Details and patient eligibility

About

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.

Enrollment: 185 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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185 participants in 3 patient groups, including a placebo group

VB-201 20 mg

Experimental group

Treatment:

Drug: VB-201

Drug: VB-201

VB-201 80 mg

Experimental group

Treatment:

Drug: VB-201

Drug: VB-201

Placebo

Placebo Comparator group

Description:

Single daily dose of oral placebo

Treatment:

Other: Placebo