Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
185 participants
INTERVENTIONAL
2009-12-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VB-201 20 mg
VB-201
Single daily dose of oral VB-201 20 mg
VB-201 80 mg
VB-201
Single daily dose or oral VB-201 80 mg
Placebo
Single daily dose of oral placebo
Placebo
Single daily dose of oral placebo
Interventions
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VB-201
Single daily dose of oral VB-201 20 mg
VB-201
Single daily dose or oral VB-201 80 mg
Placebo
Single daily dose of oral placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Vascular Biogenics Ltd. operating as VBL Therapeutics
INDUSTRY
Responsible Party
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Locations
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Alexa Kimball, MD, Massachusetts General and Brigham and Women's Hospital
Boston, Massachusetts, United States
Mark Amster, MD, Boston Clinical Trials
Boston, Massachusetts, United States
David Greenstein, MD, ActivMed Practices and Research
Haverhill (Boston), Massachusetts, United States
Craig Leonardi, MD, Central Dermatology
St Louis, Missouri, United States
Bruce Strober, MD, New York University Medical Center, Dermatologic Associates
New York, New York, United States
Gary Goldenberg, MD, Mount Sinai School of Medicine
New York, New York, United States
Julian MacKay Wiggan, MD, Columbia University Medical Center
New York, New York, United States
Steven Cohen, MD, Montefiore Medical Center, Dermatology
New York, New York, United States
Joseph D. Sutton, MD, PC
Suffern, New York, United States
Kristina Callis-Duffin, MD, University of Utah
Salt Lake City, Utah, United States
Sandra Philipp, MD, Charité Campus Mitte, Universitaetsmedizin Berlin
Berlin, , Germany
Rolf Dominicus, MD, Praxisklinik und Gemeinschaftspraxis
Dülmen, , Germany
Bernhard Homey, MD, Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
Diamant Thaci, MD, Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt, , Germany
Ulrich Mrowietz, MD, Universitaetsklinikum Schleswig-Holstein
Kiel, , Germany
Michael Sebastian, MD, SCIDerm GmbH
Mahlow, , Germany
Rudolf Schopf, MD, Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, , Germany
Professor Michael David, MD, Beilinson Hospital
Petach Tikvah, , Israel
Countries
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Other Identifiers
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VB-201-006
Identifier Type: -
Identifier Source: org_study_id