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Completed

NCT Number: NCT01001468

Study to Assess VB-201 in Patients With 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sandra Philipp, MD, Charité Campus Mitte, Universitaetsmedizin Berlin, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VB-201

Drug

Single daily dose of oral VB-201 20 mg

Placebo

Other

Single daily dose of oral placebo

Primary outcomes

  1. Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12

    Time frame: 20 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Vascular Biogenics Ltd. operating as VBL Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 26, 2009
Registry last updated
Nov 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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