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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837420
• Other study ID #: VB-201-079
• Status: Completed
• Phase: Phase 2
• First received: December 1, 2012
• Last updated: March 26, 2015
• Start date: November 2012
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: Vascular Biogenics Ltd. operating as VBL Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)Spain: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• VB-201 80mg

• VB-201 160mg

• Placebo

Locations

Country	Name	City	State
Germany	VBL Investigative Site	Kiel
Israel	VBL Investigative Site	Netanya
Poland	VBL Investigative Site	Warsaw
Spain	VBL Investigative Site	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Biogenics Ltd. operating as VBL Therapeutics

Countries where clinical trial is conducted

Germany,  Israel,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency of Adverse Events	As measured by changes from baseline in physical exam, vital signs, ECG, concomitant medications, laboratory values.	From Baseline through safety follow up at Week 28	Yes
Other	Body Surface Area	Change in affected Body Surface Area (BSA) from baseline to Week 16 and Week 24 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo.	Week 16 and Week 24	No
Other	Physician Global Assessment	Change in PGA scores from baseline to Weeks 16 and 24 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the placebo group.	Week 16 and Week 24	No
Other	Patient Psoriasis Global Assessment	Change in Patient Psoriasis Global Assessment scores from baseline to Weeks 16 and 24 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the placebo group.	Week 16 and Week 24	No
Other	PASI 50- 80 mg/ day	The proportion of subjects in the VB-201 80 mg/day 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	No
Other	Change in PASI score	The mean change in the PASI score from baseline to Weeks 16 and 24 in each of the two VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the mean change in the placebo group.	Week 16 and Week 24	No
Other	Itching Visual Analogue Scale	Change in itching VAS from baseline to weeks 16 and 24 in each of the VB 201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo.	Week 16 and Week 24	No
Other	Pain Visual Analogue Scale	Change in pain VAS from baseline to weeks 16 and 24 in each of the VB 201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo.	Week 16 and Week 24	No
Other	Dermatology Life Quality Index	Change in the DLQI scores from baseline to Weeks 16 and 24 in each of the VB 201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo.	Week 16 and Week 24	No
Primary	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	No
Secondary	PASI 75	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.	Week 16 and Week 24	No