Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With Psoriasis
Lead Sponsor:
Vascular Biogenics Ltd. operating as VBL Therapeutics
Conditions:
Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT01837420
Start Date
November 1 2012
End Date
November 1 2014
Last Update
March 27 2015
Active Locations (4)
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1
VBL Investigative Site
Kiel, Germany
2
VBL Investigative Site
Netanya, Israel
3
VBL Investigative Site
Warsaw, Poland
4
VBL Investigative Site
Barcelona, Spain