Study to Assess VB-201 in Patients With Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01001468
Recruitment Status : Completed
First Posted : October 26, 2009
Last Update Posted : November 16, 2011
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics

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.

Condition or disease Intervention/treatment Phase
Active Plaque Psoriasis Drug: VB-201 Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12 [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  1. Change in PGA (Physician Global Assessment) scores from baseline to Week 12 [ Time Frame: 20 weeks ]
  2. Change in Patient Psoriasis Global Assessment scores from baseline to Week 12 [ Time Frame: 20 weeks ]
  3. Change in affected Body Surface Area (BSA) from baseline to Week 12 [ Time Frame: 20 weeks ]
  4. Measurement of improvement in the PASI (50) from baseline at Week 12 [ Time Frame: 20 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01001468

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
Bruce Strober, MD, New York University Medical Center, Dermatologic Associates
New York, New York, United States, 10016
Gary Goldenberg, MD, Mount Sinai School of Medicine
New York, New York, United States, 10029
Julian MacKay Wiggan, MD, Columbia University Medical Center
New York, New York, United States, 10032
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
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
Professor Michael David, MD, Beilinson Hospital
Petach Tikvah, Israel
Sponsors and Collaborators
Vascular Biogenics Ltd. operating as VBL Therapeutics

Responsible Party: Vascular Biogenics Ltd. operating as VBL Therapeutics Identifier: NCT01001468     History of Changes
Other Study ID Numbers: VB-201-006
First Posted: October 26, 2009    Key Record Dates
Last Update Posted: November 16, 2011
Last Verified: November 2011

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

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases