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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: VB-201 160mg; Drug: VB-201 80mg

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Kiel, Germany
    • VBL Investigative Site
• Israel
  • Netanya, Israel
    • VBL Investigative Site
• Poland
  • Warsaw, Poland
    • VBL Investigative Site
• Spain
  • Barcelona, Spain
    • VBL Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Adverse Events	As measured by changes from baseline in physical exam, vital signs, ECG, concomitant medications, laboratory values.	From Baseline through safety follow up at Week 28
Body Surface Area	Change in affected Body Surface Area (BSA) from baseline to Week 16 and Week 24 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo.	Week 16 and Week 24
Physician Global Assessment	Change in PGA scores from baseline to Weeks 16 and 24 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the placebo group.	Week 16 and Week 24
Patient Psoriasis Global Assessment	Change in Patient Psoriasis Global Assessment scores from baseline to Weeks 16 and 24 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the placebo group.	Week 16 and Week 24
PASI 50- 80 mg/ day	The proportion of subjects in the VB-201 80 mg/day 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
Change in PASI score	The mean change in the PASI score from baseline to Weeks 16 and 24 in each of the two VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the mean change in the placebo group.	Week 16 and Week 24
Itching Visual Analogue Scale	Change in itching VAS from baseline to weeks 16 and 24 in each of the VB 201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo.	Week 16 and Week 24
Pain Visual Analogue Scale	Change in pain VAS from baseline to weeks 16 and 24 in each of the VB 201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo.	Week 16 and Week 24
Dermatology Life Quality Index	Change in the DLQI scores from baseline to Weeks 16 and 24 in each of the VB 201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo.	Week 16 and Week 24

Collaborators and Investigators

• Sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: December 1, 2012
• First Submitted That Met QC Criteria: April 17, 2013
• First Posted (Estimate): April 23, 2013

Study Record Updates

• Last Update Posted (Estimate): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 26, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: VB-201-079