Study to Assess VB-201 in Patients With Psoriasis

Completed · Phase 2 · Has a placebo group

Conditions studied: Active Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT01001468

Run by

Vascular Biogenics Ltd. operating as VBL Therapeutics

People needed

185

Starts

2009-12-01

Expected to finish

2011-07-01

Last updated by the study team

2011-11-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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