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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839214
• Other study ID #: VB-201-064
• Status: Completed
• Phase: Phase 2
• First received: April 21, 2013
• Last updated: March 26, 2015
• Start date: January 2013
• 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: Hungary: National Institute for Quality and Organizational Development in Healthcare and MedicinesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsBulgaria: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• VB-201 160mg

• Placebo

Locations

Country	Name	City	State
Bulgaria	VBL Investigative Site	Sofia
Hungary	VBL Investigative Site	Szombathely
Poland	VBL Investigative Site	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Biogenics Ltd. operating as VBL Therapeutics

Countries where clinical trial is conducted

Bulgaria,  Hungary,  Poland, 

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	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	No
Other	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	No
Other	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	No
Primary	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	No
Secondary	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	No