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

Phase 2

Completed

• Conditions: Psoriasis
• Interventions: Drug: VB-201 160mg; Drug: VB-201 80mg; Drug: Placebo

• Registration Number: NCT01837420
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-12-01
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-23
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
PASI 50	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

Name	Time	Method
PASI 75	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.

Trial Locations

Locations (1)

VBL Investigative Site; 🇪🇸 Barcelona, Spain