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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-11-30

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.

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo with crossover to VB-201 160mg

Subjects on placebo will crossover to VB-201 160 at week 16.

Group Type OTHER

VB-201 160mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

VB-201 80mg

Subjects will receive VB-201 80mg/day for 24 weeks

Group Type EXPERIMENTAL

VB-201 80mg

Intervention Type DRUG

VB-201 160mg

Subjects will received 80mg twice daily for 24 weeks

Group Type EXPERIMENTAL

VB-201 160mg

Intervention Type DRUG

Interventions

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VB-201 80mg

Intervention Type DRUG

VB-201 160mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No