Clinical trial NCT01837420: A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With Psoriasis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics
Sponsor class: INDUSTRY
First posted: 2013-04-23
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: PASI 50
timeFrame: Week 16 and Week 24
Secondary outcomes:
measure: PASI 75
timeFrame: Week 16 and Week 24
Other outcomes:
measure: Frequency of Adverse Events
timeFrame: From Baseline through safety follow up at Week 28
measure: Body Surface Area
timeFrame: Week 16 and Week 24
measure: Physician Global Assessment
timeFrame: Week 16 and Week 24
measure: Patient Psoriasis Global Assessment
timeFrame: Week 16 and Week 24
measure: PASI 50- 80 mg/ day
timeFrame: Week 16 and Week 24
measure: Change in PASI score
timeFrame: Week 16 and Week 24
measure: Itching Visual Analogue Scale
timeFrame: Week 16 and Week 24
measure: Pain Visual Analogue Scale
timeFrame: Week 16 and Week 24
measure: Dermatology Life Quality Index
timeFrame: Week 16 and Week 24
Locations:
city: Kiel
country: Germany
facility: VBL Investigative Site
city: Netanya
country: Israel
facility: VBL Investigative Site
city: Warsaw
country: Poland
facility: VBL Investigative Site
city: Barcelona
country: Spain
facility: VBL Investigative Site
Study officials:
References: