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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
VB-201 80mg
VB-201 160mg
Placebo
Sponsored by
Vascular Biogenics Ltd. operating as VBL Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VBL Investigative Site
  • VBL Investigative Site
  • VBL Investigative Site
  • VBL Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

Placebo with crossover to VB-201 160mg

VB-201 80mg

VB-201 160mg

Arm Description

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

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

Subjects will received 80mg twice daily for 24 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 1, 2012
Last Updated
March 26, 2015
Sponsor
Vascular Biogenics Ltd. operating as VBL Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01837420
Brief Title
A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With Psoriasis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vascular Biogenics Ltd. operating as VBL Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo with crossover to VB-201 160mg
Arm Type
Other
Arm Description
Subjects on placebo will crossover to VB-201 160 at week 16.
Arm Title
VB-201 80mg
Arm Type
Experimental
Arm Description
Subjects will receive VB-201 80mg/day for 24 weeks
Arm Title
VB-201 160mg
Arm Type
Experimental
Arm Description
Subjects will received 80mg twice daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
VB-201 80mg
Intervention Type
Drug
Intervention Name(s)
VB-201 160mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
PASI 50
Description
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.
Time Frame
Week 16 and Week 24
Secondary Outcome Measure Information:
Title
PASI 75
Description
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.
Time Frame
Week 16 and Week 24
Other Pre-specified Outcome Measures:
Title
Frequency of Adverse Events
Description
As measured by changes from baseline in physical exam, vital signs, ECG, concomitant medications, laboratory values.
Time Frame
From Baseline through safety follow up at Week 28
Title
Body Surface Area
Description
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.
Time Frame
Week 16 and Week 24
Title
Physician Global Assessment
Description
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.
Time Frame
Week 16 and Week 24
Title
Patient Psoriasis Global Assessment
Description
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.
Time Frame
Week 16 and Week 24
Title
PASI 50- 80 mg/ day
Description
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.
Time Frame
Week 16 and Week 24
Title
Change in PASI score
Description
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.
Time Frame
Week 16 and Week 24
Title
Itching Visual Analogue Scale
Description
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.
Time Frame
Week 16 and Week 24
Title
Pain Visual Analogue Scale
Description
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.
Time Frame
Week 16 and Week 24
Title
Dermatology Life Quality Index
Description
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.
Time Frame
Week 16 and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
VBL Investigative Site
City
Kiel
Country
Germany
Facility Name
VBL Investigative Site
City
Netanya
Country
Israel
Facility Name
VBL Investigative Site
City
Warsaw
Country
Poland
Facility Name
VBL Investigative Site
City
Barcelona
Country
Spain

12. IPD Sharing Statement

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

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