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

A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects With Mild to Moderate Ulcerative Colitis

This study will examine the safety and efficacy in subjects with mild to moderate ulcerative colitis, as measured by Modified Mayo Score, Modified Baron Score, IBDQ, calprotectin and other assessments.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Placebo; Drug: VB-201 160mg

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria
    • VBL Investigative Site
• Hungary
  • Szombathely, Hungary
    • VBL Investigative Site
• Poland
  • Warsaw, Poland
    • VBL Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, ≥18 years of age, who has a diagnosis of active UC for at least 6 months prior to screening
• A rectal/colonic biopsy obtained previously and consistent with a diagnosis of UC
• Endoscopy (flexible sigmoidoscopy unless surveillance colonoscopy is clinically indicated) confirming diagnosis of UC within 2 weeks prior to randomization
• Endoscopy (flexible sigmoidoscopy unless surveillance colonoscopy is clinically indicated) confirming diagnosis of UC within 2 weeks prior to randomization
• Active UC despite previous treatment with at least one 5-ASA compound at a dose of ≥2000 mg/day for at least 4 weeks or documented intolerance to such therapy

Exclusion Criteria:

• Diagnosis of indeterminate colitis, Crohn's disease, or clinical findings suggestive of Crohn's disease (fistula or granulomas on biopsy) or microscopic colitis (collagenous colitis or lymphocytic colitis)
• Subject whose symptoms are likely caused by factors other than inflammatory UC, including infection or irritable bowel syndrome (IBS)
• History of dysplasia on colonic biopsy
• Subject with ≥ 8 year history of pancolitis or ≥ 15 year history of left sided colitis unless a colonoscopy with surveillance biopsies to screen for colon cancer has been performed within the past year
• Subject ≥ 50 years of age who has not had a colonoscopy to screen for colorectal polyps and colon cancer within the past 5 years
• Subject who has had any prior surgical resection of any part of the colon excluding the appendix
• Previous treatment with any biologic product including investigational biologic products within 1 year prior to baseline visit
• The subject is taking Systemic corticosteroids, Azathioprine/6-mercaptopurine/methotrexate, immunosuppressants, Oral 5-ASA compounds unless they have been on a stable dose of sufficient duration prior to Baseline. If recently discontinued the subject must have had a wash-out periods of sufficient duration prior to Baseline
• Rectally administered corticosteroids or 5-ASA, antibiotics for the treatment of UC and probiotics within 14 days of the Baseline Visit and throughout the study
• The subject has with a stool culture positive for pathogenic ova or parasites, enteric pathogens or Clostridium difficile toxin at the Screening Visit
• Presence of, or history of cancer, with the exception of skin cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: VB-201 160mg; Subjects will received 80mg twice daily for 24 weeks.	Drug: VB-201 160mg
PLACEBO_COMPARATOR: Placebo with crossover to VB-201 160mg; Subjects on placebo will crossover to VB-201 160 at week 12.	Drug: Placebo; Drug: VB-201 160mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Mayo Score indicating remission	The proportion of subjects in remission at Weeks 12 and 24 in the VB-201 160mg (80 mg BID) treatment group compared to placebo group.	Week 12 and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Mayo Score indicating response	The proportion of subjects responding at Weeks 12 and 24 in the VB-201 160mg (80 mg BID) treatment group compared to placebo group.	Week 12 and Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Reduction in Modified Mayo Score	The proportion of subjects in each arm with a 2-point or greater decrease in the Modified Mayo score at Weeks 12 and 24.	Week 12 and Week 24
Modified Baron Score	Change in the modified Baron score from Baseline to Weeks 12 and 24 in the VB-201 treatment group as compared to the placebo group.	Week 12 and Week 24
Mucosal Healing	The proportion of subjects in each arm with mucosal healing at Weeks 12 and 24 in the VB-201 treatment group compared to placebo group.	Wee 12 and Week 24

Collaborators and Investigators

• Sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: April 21, 2013
• First Submitted That Met QC Criteria: April 23, 2013
• First Posted (ESTIMATE): April 24, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 26, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: VB-201-064