Study to Assess VB-201 in Patients With Psoriasis

Phase 2

Completed

• Conditions: Active Plaque Psoriasis
• Interventions: Drug: VB-201; Other: Placebo

• Registration Number: NCT01001468
• Lead Sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2009-10-23
• Study First Posted: 2009-10-26
• Study Start: 2009-12
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-15
• Last Update Posted: 2011-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VB-201 20 mg	VB-201	-
VB-201 80 mg	VB-201	-
Placebo	Placebo	Single daily dose of oral placebo

Primary Outcome Measures

Name	Time	Method
Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12	20 weeks

Secondary Outcome Measures

Name	Time	Method
Measurement of improvement in the PASI (50) from baseline at Week 12	20 weeks
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

Trial Locations

Locations (18)

Michael Sebastian, MD, SCIDerm GmbH; 🇩🇪 Mahlow, Germany

Bruce Strober, MD, New York University Medical Center, Dermatologic Associates; 🇺🇸 New York, New York, United States

David Greenstein, MD, ActivMed Practices and Research; 🇺🇸 Haverhill (Boston), Massachusetts, United States

Bernhard Homey, MD, Universitaetsklinikum Duesseldorf; 🇩🇪 Duesseldorf, Germany

Gary Goldenberg, MD, Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

Sandra Philipp, MD, Charité Campus Mitte, Universitaetsmedizin Berlin; 🇩🇪 Berlin, Germany

Diamant Thaci, MD, Klinikum der Johann Wolfgang Goethe-Universität; 🇩🇪 Frankfurt, Germany

Julian MacKay Wiggan, MD, Columbia University Medical Center; 🇺🇸 New York, New York, United States

Rolf Dominicus, MD, Praxisklinik und Gemeinschaftspraxis; 🇩🇪 Dülmen, Germany

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

Craig Leonardi, MD, Central Dermatology; 🇺🇸 St. Louis, Missouri, United States

Steven Cohen, MD, Montefiore Medical Center, Dermatology; 🇺🇸 New York, New York, United States

Ulrich Mrowietz, MD, Universitaetsklinikum Schleswig-Holstein; 🇩🇪 Kiel, Germany

Rudolf Schopf, MD, Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR; 🇩🇪 Mainz, Germany

Kristina Callis-Duffin, MD, University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Joseph D. Sutton, MD, PC; 🇺🇸 Suffern, New York, United States

Professor Michael David, MD, Beilinson Hospital; 🇮🇱 Petach Tikvah, Israel