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Study to Assess VB-201 in Patients With Psoriasis

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.
 
ClinicalTrials.gov Identifier: NCT01001468
Recruitment Status : Completed
First Posted : October 26, 2009
Last Update Posted : November 16, 2011
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Active Plaque Psoriasis Drug: VB-201 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: VB-201 20 mg Drug: VB-201
Single daily dose of oral VB-201 20 mg

Experimental: VB-201 80 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




Primary Outcome Measures :
  1. Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12 [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  1. Change in PGA (Physician Global Assessment) scores from baseline to Week 12 [ Time Frame: 20 weeks ]
  2. Change in Patient Psoriasis Global Assessment scores from baseline to Week 12 [ Time Frame: 20 weeks ]
  3. Change in affected Body Surface Area (BSA) from baseline to Week 12 [ Time Frame: 20 weeks ]
  4. Measurement of improvement in the PASI (50) from baseline at Week 12 [ Time Frame: 20 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01001468


Locations
Show Show 18 study locations
Sponsors and Collaborators
Vascular Biogenics Ltd. operating as VBL Therapeutics
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Responsible Party: Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier: NCT01001468    
Other Study ID Numbers: VB-201-006
First Posted: October 26, 2009    Key Record Dates
Last Update Posted: November 16, 2011
Last Verified: November 2011
Keywords provided by Vascular Biogenics Ltd. operating as VBL Therapeutics:
Psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases