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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VB-201 20 mg | Experimental |
| |
| VB-201 80 mg | Experimental |
| |
| Placebo | Placebo Comparator | Single daily dose of oral placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VB-201 | Drug | Single daily dose of oral VB-201 20 mg |
| |
| VB-201 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12 | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexa Kimball, MD, Massachusetts General and Brigham and Women's Hospital | Boston | Massachusetts | 02114 | United States | ||
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| Drug |
Single daily dose or oral VB-201 80 mg |
|
| Placebo | Other | Single daily dose of oral placebo |
|
| 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 |
| 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 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C552500 | 1-palmityl-2-(4-carboxybutyl)-sn-glycero-3-phosphocholine |
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