Active Plaque Psoriasis
Conditions
Keywords
Psoriasis
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.
Interventions
DRUGVB-201
Single daily dose of oral VB-201 20 mg
OTHERPlacebo
Single daily dose of oral placebo
Sponsors
Vascular Biogenics Ltd. operating as VBL Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12 | 20 weeks |
Secondary
| Measure | 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 |
Countries
Germany, Israel, United States
Outcome results
None listed