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Study to Assess VB-201 in Patients With Psoriasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01001468
First Posted: October 26, 2009
Last Update Posted: November 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics
October 20, 2009
October 26, 2009
November 16, 2011
December 2009
July 2011   (Final data collection date for primary outcome measure)
Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12 [ Time Frame: 20 weeks ]
Same as current
Complete list of historical versions of study NCT01001468 on ClinicalTrials.gov Archive Site
  • Change in PGA (Physician Global Assessment) scores from baseline to Week 12 [ Time Frame: 20 weeks ]
  • Change in Patient Psoriasis Global Assessment scores from baseline to Week 12 [ Time Frame: 20 weeks ]
  • Change in affected Body Surface Area (BSA) from baseline to Week 12 [ Time Frame: 20 weeks ]
  • Measurement of improvement in the PASI (50) from baseline at Week 12 [ Time Frame: 20 weeks ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Active Plaque Psoriasis
  • Drug: VB-201
    Single daily dose of oral VB-201 20 mg
  • Drug: VB-201
    Single daily dose or oral VB-201 80 mg
  • Other: Placebo
    Single daily dose of oral placebo
  • Experimental: VB-201 20 mg
    Intervention: Drug: VB-201
  • Experimental: VB-201 80 mg
    Intervention: Drug: VB-201
  • Placebo Comparator: Placebo
    Single daily dose of oral placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
185
July 2011
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Israel,   United States
 
 
NCT01001468
VB-201-006
Yes
Not Provided
Not Provided
Vascular Biogenics Ltd. operating as VBL Therapeutics
Vascular Biogenics Ltd. operating as VBL Therapeutics
Not Provided
Not Provided
Vascular Biogenics Ltd. operating as VBL Therapeutics
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP