A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With Psoriasis

Study Overview
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Brief Summary
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This study will examine the safety and efficacy in subjects with moderate to severe psoriasis, as measured by Psoriasis Area and Severity Index(PASI), Body Surface Area (BSA), Dermatology Life Quality Index (DLQI) and other assessments.

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

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: VB-201 80mg
* Drug: VB-201 160mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, ≥18 to ≤75 years of age, who have a diagnosis of chronic plaque psoriasis for at least 6 months prior to screening; Plaque psoriasis covering between 10% to 30 % of body surface area (BSA); PASI severity moderate to severe, scoring at least 10 but no higher than 20. Exclusion Criteria: The subject presents with psoriasis that is predominantly guttate, erythrodermic, inverse, pustular or palmo-plantar or an unstable form of psoriasis; Previously failed (due to lack of efficacy) treatment with at least one systemic biologic agent for psoriasis (e.g. ustekinumab, adalimumab, etanercept, etc); The subject has not undergone wash-out periods of sufficient duration for the following treatments at Baseline: Topical psoriasis treatments: 2 weeks; Systemic (non-biologic) psoriasis treatments: 4 weeks or 5 half-lives (whichever is longer); Biologic psoriasis treatments: 8 weeks or 5 half lives (whichever is longer); Phototherapy: 4 weeks; The subject anticipates getting enough ultra-violet light during the study (e.g. sunbathing; tanning salon, etc.) to cause psoriasis to improve; History of cancer, with the exception of skin cancer.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Placebo with crossover to VB-201 160mg<br>Subjects on placebo will crossover to VB-201 160 at week 16. | Drug: VB-201 160mg<br> <br> Drug: Placebo<br> <br> |
| Experimental: VB-201 80mg<br>Subjects will receive VB-201 80mg/day for 24 weeks | Drug: VB-201 80mg<br> <br> |
| Experimental: VB-201 160mg<br>Subjects will received 80mg twice daily for 24 weeks | Drug: VB-201 160mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI 50 | The proportion of subjects in the VB-201 160 mg (80 mg BID) treatment group who achieve at least 50% improvement from the baseline PASI score at Weeks 16 and 24 (PASI 50) compared to the proportion of PASI 50 responders in the placebo group. | Week 16 and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI 75 | Proportion of subjects in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups who achieve at least 75% improvement from the baseline PASI score (PASI 75) at Weeks 16 and 24 compared to the proportion of PASI 75 responders in the placebo group. | Week 16 and Week 24 |