NCT01837420

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2012

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

2 years

First QC Date

December 1, 2012

Last Update Submit

March 26, 2015

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • PASI 50

    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.

    Week 16 and Week 24

Secondary Outcomes (1)

  • PASI 75

    Week 16 and Week 24

Other Outcomes (9)

  • Frequency of Adverse Events

    From Baseline through safety follow up at Week 28

  • Body Surface Area

    Week 16 and Week 24

  • Physician Global Assessment

    Week 16 and Week 24

  • +6 more other outcomes

Study Arms (3)

Placebo with crossover to VB-201 160mg

OTHER

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

Drug: VB-201 160mgDrug: Placebo

VB-201 80mg

EXPERIMENTAL

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

Drug: VB-201 80mg

VB-201 160mg

EXPERIMENTAL

Subjects will received 80mg twice daily for 24 weeks

Drug: VB-201 160mg

Interventions

VB-201 80mgDRUG
VB-201 80mg
VB-201 160mgDRUG
Placebo with crossover to VB-201 160mgVB-201 160mg
PlaceboDRUG
Placebo with crossover to VB-201 160mg

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

VBL Investigative Site

Kiel, Germany

Location

VBL Investigative Site

Netanya, Israel

Location

VBL Investigative Site

Warsaw, Poland

Location

VBL Investigative Site

Barcelona, Spain

Location

MeSH Terms

Conditions

Psoriasis

Interventions

1-palmityl-2-(4-carboxybutyl)-sn-glycero-3-phosphocholine

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2012

First Posted

April 23, 2013

Study Start

November 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 27, 2015

Record last verified: 2015-03

Locations

IL(1)ES(1)DE(1)PL(1)