Study to Assess VB-201 in Patients With Psoriasis

November 15, 2011 updated by: Vascular Biogenics Ltd. operating as VBL Therapeutics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
185

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Sandra Philipp, MD, Charité Campus Mitte, Universitaetsmedizin Berlin
      • Duesseldorf, Germany, 40225
        • Bernhard Homey, MD, Universitaetsklinikum Duesseldorf
      • Dülmen, Germany, 48249
        • Rolf Dominicus, MD, Praxisklinik und Gemeinschaftspraxis
      • Frankfurt, Germany, 60590
        • Diamant Thaci, MD, Klinikum der Johann Wolfgang Goethe-Universität
      • Kiel, Germany, 24105
        • Ulrich Mrowietz, MD, Universitaetsklinikum Schleswig-Holstein
      • Mahlow, Germany, 15831
        • Michael Sebastian, MD, SCIDerm GmbH
      • Mainz, Germany, 55131
        • Rudolf Schopf, MD, Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
  • Israel
      • Petach Tikvah, Israel
        • Professor Michael David, MD, Beilinson Hospital
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Alexa Kimball, MD, Massachusetts General and Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02135
        • Mark Amster, MD, Boston Clinical Trials
      • Haverhill (Boston), Massachusetts, United States, 01830
        • David Greenstein, MD, ActivMed Practices and Research
    • Missouri
      • St. Louis, Missouri, United States, 63117
        • Craig Leonardi, MD, Central Dermatology
    • New York
      • New York, New York, United States, 10016
        • Bruce Strober, MD, New York University Medical Center, Dermatologic Associates
      • New York, New York, United States, 10029
        • Gary Goldenberg, MD, Mount Sinai School of Medicine
      • New York, New York, United States, 10032
        • Julian MacKay Wiggan, MD, Columbia University Medical Center
      • New York, New York, United States, 10467
        • Steven Cohen, MD, Montefiore Medical Center, Dermatology
      • Suffern, New York, United States, 10901
        • Joseph D. Sutton, MD, PC
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Kristina Callis-Duffin, MD, University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: VB-201 20 mg
Drug: VB-201
Single daily dose of oral VB-201 20 mg
Drug: VB-201
Single daily dose or oral VB-201 80 mg
EXPERIMENTAL: VB-201 80 mg
Drug: VB-201
Single daily dose of oral VB-201 20 mg
Drug: VB-201
Single daily dose or oral VB-201 80 mg
PLACEBO_COMPARATOR: Placebo
Single daily dose of oral placebo
Other: Placebo
Single daily dose of oral placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12
Time Frame: 20 weeks
20 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in PGA (Physician Global Assessment) scores from baseline to Week 12
Time Frame: 20 weeks
20 weeks
Change in Patient Psoriasis Global Assessment scores from baseline to Week 12
Time Frame: 20 weeks
20 weeks
Change in affected Body Surface Area (BSA) from baseline to Week 12
Time Frame: 20 weeks
20 weeks
Measurement of improvement in the PASI (50) from baseline at Week 12
Time Frame: 20 weeks
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vascular Biogenics Ltd. operating as VBL Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VB-201-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings