Active Plaque Psoriasis Clinical Trial
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
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.
| Status | Completed |
| Enrollment | 185 |
| Est. completion date | July 2011 |
| Est. primary completion date | July 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Sandra Philipp, MD, Charité Campus Mitte, Universitaetsmedizin Berlin | Berlin | |
| Germany | Bernhard Homey, MD, Universitaetsklinikum Duesseldorf | Duesseldorf | |
| Germany | Rolf Dominicus, MD, Praxisklinik und Gemeinschaftspraxis | Dülmen | |
| 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 | |
| Israel | Professor Michael David, MD, Beilinson Hospital | Petach Tikvah | |
| United States | 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 | 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 | Kristina Callis-Duffin, MD, University of Utah | Salt Lake City | Utah |
| United States | Craig Leonardi, MD, Central Dermatology | St. Louis | Missouri |
| United States | Joseph D. Sutton, MD, PC | Suffern | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Vascular Biogenics Ltd. operating as VBL Therapeutics |
United States, Germany, Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12 | 20 weeks | No | |
| Secondary | Change in PGA (Physician Global Assessment) scores from baseline to Week 12 | 20 weeks | No | |
| Secondary | Change in Patient Psoriasis Global Assessment scores from baseline to Week 12 | 20 weeks | No | |
| Secondary | Change in affected Body Surface Area (BSA) from baseline to Week 12 | 20 weeks | No | |
| Secondary | Measurement of improvement in the PASI (50) from baseline at Week 12 | 20 weeks | No |