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Study to Assess VB-201 in Patients With Psoriasis

Primary Purpose

Active Plaque Psoriasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
VB-201
VB-201
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 Active Plaque Psoriasis focused on measuring Psoriasis

Eligibility Criteria

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

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

Sites / Locations

  • Alexa Kimball, MD, Massachusetts General and Brigham and Women's Hospital
  • Mark Amster, MD, Boston Clinical Trials
  • David Greenstein, MD, ActivMed Practices and Research
  • Craig Leonardi, MD, Central Dermatology
  • Bruce Strober, MD, New York University Medical Center, Dermatologic Associates
  • Gary Goldenberg, MD, Mount Sinai School of Medicine
  • Julian MacKay Wiggan, MD, Columbia University Medical Center
  • Steven Cohen, MD, Montefiore Medical Center, Dermatology
  • Joseph D. Sutton, MD, PC
  • Kristina Callis-Duffin, MD, University of Utah
  • Sandra Philipp, MD, Charité Campus Mitte, Universitaetsmedizin Berlin
  • Bernhard Homey, MD, Universitaetsklinikum Duesseldorf
  • Rolf Dominicus, MD, Praxisklinik und Gemeinschaftspraxis
  • Diamant Thaci, MD, Klinikum der Johann Wolfgang Goethe-Universität
  • Ulrich Mrowietz, MD, Universitaetsklinikum Schleswig-Holstein
  • Michael Sebastian, MD, SCIDerm GmbH
  • Rudolf Schopf, MD, Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
  • Professor Michael David, MD, Beilinson Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

VB-201 20 mg

VB-201 80 mg

Placebo

Arm Description

Single daily dose of oral placebo

Outcomes

Primary Outcome Measures

Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12

Secondary Outcome Measures

Change in PGA (Physician Global Assessment) scores from baseline to Week 12
Change in Patient Psoriasis Global Assessment scores from baseline to Week 12
Change in affected Body Surface Area (BSA) from baseline to Week 12
Measurement of improvement in the PASI (50) from baseline at Week 12

Full Information

First Posted
October 20, 2009
Last Updated
November 15, 2011
Sponsor
Vascular Biogenics Ltd. operating as VBL Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01001468
Brief Title
Study to Assess VB-201 in Patients With Psoriasis
Official Title
A Randomized, Double-Blind, 12-Week, 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
November 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (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
Yes

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
VB-201 20 mg
Arm Type
Experimental
Arm Title
VB-201 80 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single daily dose of oral placebo
Intervention Type
Drug
Intervention Name(s)
VB-201
Intervention Description
Single daily dose of oral VB-201 20 mg
Intervention Type
Drug
Intervention Name(s)
VB-201
Intervention Description
Single daily dose or oral VB-201 80 mg
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Single daily dose of oral placebo
Primary Outcome Measure Information:
Title
Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Change in PGA (Physician Global Assessment) scores from baseline to Week 12
Time Frame
20 weeks
Title
Change in Patient Psoriasis Global Assessment scores from baseline to Week 12
Time Frame
20 weeks
Title
Change in affected Body Surface Area (BSA) from baseline to Week 12
Time Frame
20 weeks
Title
Measurement of improvement in the PASI (50) from baseline at Week 12
Time Frame
20 weeks

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 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
Facility Information:
Facility Name
Alexa Kimball, MD, Massachusetts General and Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mark Amster, MD, Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
David Greenstein, MD, ActivMed Practices and Research
City
Haverhill (Boston)
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
Craig Leonardi, MD, Central Dermatology
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Bruce Strober, MD, New York University Medical Center, Dermatologic Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Gary Goldenberg, MD, Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Julian MacKay Wiggan, MD, Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Steven Cohen, MD, Montefiore Medical Center, Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Joseph D. Sutton, MD, PC
City
Suffern
State/Province
New York
ZIP/Postal Code
10901
Country
United States
Facility Name
Kristina Callis-Duffin, MD, University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Sandra Philipp, MD, Charité Campus Mitte, Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Bernhard Homey, MD, Universitaetsklinikum Duesseldorf
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Rolf Dominicus, MD, Praxisklinik und Gemeinschaftspraxis
City
Dülmen
ZIP/Postal Code
48249
Country
Germany
Facility Name
Diamant Thaci, MD, Klinikum der Johann Wolfgang Goethe-Universität
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Ulrich Mrowietz, MD, Universitaetsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Michael Sebastian, MD, SCIDerm GmbH
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
Rudolf Schopf, MD, Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Professor Michael David, MD, Beilinson Hospital
City
Petach Tikvah
Country
Israel

12. IPD Sharing Statement

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Study to Assess VB-201 in Patients With Psoriasis

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