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Completed

NCT Number: NCT01837420

A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With Psoriasis

This study will examine the safety and efficacy in subjects with moderate to severe psoriasis, as measured by Psoriasis Area and Severity Index(PASI), Body Surface Area (BSA), Dermatology Life Quality Index (DLQI) and other assessments.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VBL Investigative Site, Kiel, 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 subjects, ≥18 to ≤75 years of age, who have a diagnosis of chronic plaque psoriasis for at least 6 months prior to screening;
  • Plaque psoriasis covering between 10% to 30 % of body surface area (BSA);
  • PASI severity moderate to severe, scoring at least 10 but no higher than 20.

Exclusion criteria

  • The subject presents with psoriasis that is predominantly guttate, erythrodermic, inverse, pustular or palmo-plantar or an unstable form of psoriasis;
  • Previously failed (due to lack of efficacy) treatment with at least one systemic biologic agent for psoriasis (e.g. ustekinumab, adalimumab, etanercept, etc);
  • The subject has not undergone wash-out periods of sufficient duration for the following treatments at Baseline: Topical psoriasis treatments: 2 weeks; Systemic (non-biologic) psoriasis treatments: 4 weeks or 5 half-lives (whichever is longer); Biologic psoriasis treatments: 8 weeks or 5 half lives (whichever is longer); Phototherapy: 4 weeks;
  • The subject anticipates getting enough ultra-violet light during the study (e.g. sunbathing; tanning salon, etc.) to cause psoriasis to improve;
  • History of cancer, with the exception of skin cancer.

Treatment and study plan

VB-201 80mg

Drug

VB-201 160mg

Drug

Placebo

Drug

Primary outcomes

  1. PASI 50

    Time frame: Week 16 and Week 24

    The proportion of subjects in the VB-201 160 mg (80 mg BID) treatment group who achieve at least 50% improvement from the baseline PASI score at Weeks 16 and 24 (PASI 50) compared to the proportion of PASI 50 responders in the placebo group.

Secondary outcomes

  1. PASI 75

    Time frame: Week 16 and Week 24

    Proportion of subjects in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups who achieve at least 75% improvement from the baseline PASI score (PASI 75) at Weeks 16 and 24 compared to the proportion of PASI 75 responders in the placebo group.

Other outcomes

  1. Frequency of Adverse Events

    Time frame: From Baseline through safety follow up at Week 28

    As measured by changes from baseline in physical exam, vital signs, ECG, concomitant medications, laboratory values.

  2. Body Surface Area

    Time frame: Week 16 and Week 24

    Change in affected Body Surface Area (BSA) from baseline to Week 16 and Week 24 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo.

  3. Physician Global Assessment

    Time frame: Week 16 and Week 24

    Change in PGA scores from baseline to Weeks 16 and 24 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the placebo group.

  4. Patient Psoriasis Global Assessment

    Time frame: Week 16 and Week 24

    Change in Patient Psoriasis Global Assessment scores from baseline to Weeks 16 and 24 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the placebo group.

  5. PASI 50- 80 mg/ day

    Time frame: Week 16 and Week 24

    The proportion of subjects in the VB-201 80 mg/day treatment group who achieve at least 50% improvement from the baseline PASI score at Weeks 16 and 24 (PASI 50) compared to the proportion of PASI 50 responders in the placebo group.

  6. Change in PASI score

    Time frame: Week 16 and Week 24

    The mean change in the PASI score from baseline to Weeks 16 and 24 in each of the two VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the mean change in the placebo group.

  7. Itching Visual Analogue Scale

    Time frame: Week 16 and Week 24

    Change in itching VAS from baseline to weeks 16 and 24 in each of the VB 201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo.

  8. Pain Visual Analogue Scale

    Time frame: Week 16 and Week 24

    Change in pain VAS from baseline to weeks 16 and 24 in each of the VB 201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo.

  9. Dermatology Life Quality Index

    Time frame: Week 16 and Week 24

    Change in the DLQI scores from baseline to Weeks 16 and 24 in each of the VB 201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo.

Sponsors and collaborators

Lead sponsor

Vascular Biogenics Ltd. operating as VBL Therapeutics

Industry

Registry information

Official study title

A Randomized, Double Blind, 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
2012
Primary completion
2014
Study completion
2014
First posted
Apr 23, 2013
Registry last updated
Mar 27, 2015

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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