Clinical trial NCT01001468: Study to Assess VB-201 in Patients With Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Active Plaque Psoriasis
Keywords: Psoriasis
Lead sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-10-26
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12
timeFrame: 20 weeks
Secondary outcomes:
measure: Change in PGA (Physician Global Assessment) scores from baseline to Week 12
timeFrame: 20 weeks
measure: Change in Patient Psoriasis Global Assessment scores from baseline to Week 12
timeFrame: 20 weeks
measure: Change in affected Body Surface Area (BSA) from baseline to Week 12
timeFrame: 20 weeks
measure: Measurement of improvement in the PASI (50) from baseline at Week 12
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Alexa Kimball, MD, Massachusetts General and Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Mark Amster, MD, Boston Clinical Trials
state: Massachusetts
city: Haverhill (Boston)
country: United States
facility: David Greenstein, MD, ActivMed Practices and Research
state: Massachusetts
city: St. Louis
country: United States
facility: Craig Leonardi, MD, Central Dermatology
state: Missouri
city: New York
country: United States
facility: Bruce Strober, MD, New York University Medical Center, Dermatologic Associates
state: New York
city: New York
country: United States
facility: Gary Goldenberg, MD, Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Julian MacKay Wiggan, MD, Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Steven Cohen, MD, Montefiore Medical Center, Dermatology
state: New York
city: Suffern
country: United States
facility: Joseph D. Sutton, MD, PC
state: New York
city: Salt Lake City
country: United States
facility: Kristina Callis-Duffin, MD, University of Utah
state: Utah
city: Berlin
country: Germany
facility: Sandra Philipp, MD, Charité Campus Mitte, Universitaetsmedizin Berlin
city: Duesseldorf
country: Germany
facility: Bernhard Homey, MD, Universitaetsklinikum Duesseldorf
city: Dülmen
country: Germany
facility: Rolf Dominicus, MD, Praxisklinik und Gemeinschaftspraxis
city: Frankfurt
country: Germany
facility: Diamant Thaci, MD, Klinikum der Johann Wolfgang Goethe-Universität
city: Kiel
country: Germany
facility: Ulrich Mrowietz, MD, Universitaetsklinikum Schleswig-Holstein
city: Mahlow
country: Germany
facility: Michael Sebastian, MD, SCIDerm GmbH
city: Mainz
country: Germany
facility: Rudolf Schopf, MD, Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
city: Petach Tikvah
country: Israel
facility: Professor Michael David, MD, Beilinson Hospital
Study officials:
References: