Study to Assess VB-201 in Patients With Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier:
NCT01001468
First received: October 20, 2009
Last updated: November 15, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Active Plaque Psoriasis
Drug: VB-201
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Vascular Biogenics Ltd. operating as VBL Therapeutics:

Primary Outcome Measures:
  • Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12 [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in PGA (Physician Global Assessment) scores from baseline to Week 12 [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Change in Patient Psoriasis Global Assessment scores from baseline to Week 12 [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Change in affected Body Surface Area (BSA) from baseline to Week 12 [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Measurement of improvement in the PASI (50) from baseline at Week 12 [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Enrollment: 185
Study Start Date: December 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VB-201 20 mg Drug: VB-201
Single daily dose of oral VB-201 20 mg
Experimental: VB-201 80 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001468

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

No publications provided

Responsible Party: Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier: NCT01001468     History of Changes
Other Study ID Numbers: VB-201-006
Study First Received: October 20, 2009
Last Updated: November 15, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health

Keywords provided by Vascular Biogenics Ltd. operating as VBL Therapeutics:
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014