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
1 other identifier
interventional
185
3 countries
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2009
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2009
CompletedFirst Posted
Study publicly available on registry
October 26, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedNovember 16, 2011
November 1, 2011
1.6 years
October 20, 2009
November 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12
20 weeks
Secondary Outcomes (4)
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
Study Arms (3)
VB-201 20 mg
EXPERIMENTALVB-201 80 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORSingle daily dose of oral placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Alexa Kimball, MD, Massachusetts General and Brigham and Women's Hospital
Boston, Massachusetts, 02114, United States
Mark Amster, MD, Boston Clinical Trials
Boston, Massachusetts, 02135, United States
David Greenstein, MD, ActivMed Practices and Research
Haverhill (Boston), Massachusetts, 01830, United States
Craig Leonardi, MD, Central Dermatology
St Louis, Missouri, 63117, United States
Bruce Strober, MD, New York University Medical Center, Dermatologic Associates
New York, New York, 10016, United States
Gary Goldenberg, MD, Mount Sinai School of Medicine
New York, New York, 10029, United States
Julian MacKay Wiggan, MD, Columbia University Medical Center
New York, New York, 10032, United States
Steven Cohen, MD, Montefiore Medical Center, Dermatology
New York, New York, 10467, United States
Joseph D. Sutton, MD, PC
Suffern, New York, 10901, United States
Kristina Callis-Duffin, MD, University of Utah
Salt Lake City, Utah, 84132, United States
Sandra Philipp, MD, Charité Campus Mitte, Universitaetsmedizin Berlin
Berlin, 10117, Germany
Rolf Dominicus, MD, Praxisklinik und Gemeinschaftspraxis
Dülmen, 48249, Germany
Bernhard Homey, MD, Universitaetsklinikum Duesseldorf
Düsseldorf, 40225, Germany
Diamant Thaci, MD, Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt, 60590, Germany
Ulrich Mrowietz, MD, Universitaetsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Michael Sebastian, MD, SCIDerm GmbH
Mahlow, 15831, Germany
Rudolf Schopf, MD, Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, 55131, Germany
Professor Michael David, MD, Beilinson Hospital
Petach Tikvah, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2009
First Posted
October 26, 2009
Study Start
December 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
November 16, 2011
Record last verified: 2011-11