Status:
COMPLETED
Study to Assess VB-201 in Patients With Psoriasis
Lead Sponsor:
Vascular Biogenics Ltd. operating as VBL Therapeutics
Conditions:
Active Plaque Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT01001468
Start Date
December 1 2009
End Date
July 1 2011
Last Update
November 16 2011
Active Locations (18)
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1
Alexa Kimball, MD, Massachusetts General and Brigham and Women's Hospital
Boston, Massachusetts, United States, 02114
2
Mark Amster, MD, Boston Clinical Trials
Boston, Massachusetts, United States, 02135
3
David Greenstein, MD, ActivMed Practices and Research
Haverhill (Boston), Massachusetts, United States, 01830
4
Craig Leonardi, MD, Central Dermatology
St Louis, Missouri, United States, 63117