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A Study to Evaluate the Efficacy and Safety of 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: NCT01837420
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : March 27, 2015
Sponsor:
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: VB-201 80mg Drug: VB-201 160mg Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Placebo with crossover to VB-201 160mg
Subjects on placebo will crossover to VB-201 160 at week 16.
Drug: VB-201 160mg
Drug: Placebo
Experimental: VB-201 80mg
Subjects will receive VB-201 80mg/day for 24 weeks
Drug: VB-201 80mg
Experimental: VB-201 160mg
Subjects will received 80mg twice daily for 24 weeks
Drug: VB-201 160mg



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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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 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.

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): NCT01837420


Locations
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Germany
VBL Investigative Site
Kiel, Germany
Israel
VBL Investigative Site
Netanya, Israel
Poland
VBL Investigative Site
Warsaw, Poland
Spain
VBL Investigative Site
Barcelona, Spain
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: NCT01837420    
Other Study ID Numbers: VB-201-079
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: March 27, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases