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

VBL Therapeutics

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: VB-201 160mg; Drug: VB-201 80mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01837420

VB-201-079

Details and patient eligibility

About

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.

Enrollment: 194 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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194 participants in 3 patient groups

Placebo with crossover to VB-201 160mg

Other group

Description:

Subjects on placebo will crossover to VB-201 160 at week 16.

Treatment:

Drug: VB-201 160mg

Drug: Placebo

VB-201 80mg

Experimental group

Description:

Subjects will receive VB-201 80mg/day for 24 weeks

Treatment:

Drug: VB-201 80mg

VB-201 160mg

Experimental group

Description:

Subjects will received 80mg twice daily for 24 weeks

Treatment:

Drug: VB-201 160mg