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

NCT ID: NCT01839214

Last Updated: 2015-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-11-30

Brief 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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

VB-201 160mg

Subjects will received 80mg twice daily for 24 weeks.

Group Type: EXPERIMENTAL

VB-201 160mg

Intervention Type: DRUG

Placebo with crossover to VB-201 160mg

Subjects on placebo will crossover to VB-201 160 at week 12.

Group Type: PLACEBO_COMPARATOR

VB-201 160mg

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

VB-201 160mg

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vascular Biogenics Ltd. operating as VBL Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

VBL Investigative Site

Sofia, , Bulgaria

VBL Investigative Site

Szombathely, , Hungary

VBL Investigative Site

Warsaw, , Poland

Countries

Bulgaria; Hungary; Poland

Other Identifiers

VB-201-064

Identifier Type: -

Identifier Source: org_study_id