Study to Assess VB-201 in Patients With Psoriasis

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

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.

Study Overview

• Status: Completed
• Conditions: Active Plaque Psoriasis
• Intervention / Treatment: Drug: VB-201; Drug: VB-201; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Phase 2

Contacts and Locations

Study Locations

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

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: VB-201 20 mg	Drug: VB-201; Single daily dose of oral VB-201 20 mg; Drug: VB-201; Single daily dose or oral VB-201 80 mg
EXPERIMENTAL: VB-201 80 mg	Drug: VB-201; Single daily dose of oral VB-201 20 mg; Drug: VB-201; Single daily dose or oral VB-201 80 mg
PLACEBO_COMPARATOR: Placebo; Single daily dose of oral placebo	Other: Placebo; Single daily dose of oral placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12	20 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in PGA (Physician Global Assessment) scores from baseline to Week 12	20 weeks
Change in Patient Psoriasis Global Assessment scores from baseline to Week 12	20 weeks
Change in affected Body Surface Area (BSA) from baseline to Week 12	20 weeks
Measurement of improvement in the PASI (50) from baseline at Week 12	20 weeks

Collaborators and Investigators

• Sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): July 1, 2011

Study Registration Dates

• First Submitted: October 20, 2009
• First Submitted That Met QC Criteria: October 23, 2009
• First Posted (ESTIMATE): October 26, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): November 16, 2011
• Last Update Submitted That Met QC Criteria: November 15, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: VB-201-006