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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 April 2015
• Main ID: NCT01839214
• Date of registration: 21/04/2013
• Prospective Registration: No
• Primary sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics
• Public title: A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With Ulcerative Colitis
• Scientific 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
• Date of first enrolment: January 2013
• Target sample size: 112
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01839214
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Bulgaria, Hungary, Poland

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Placebo

Drug: VB-201 160mg

Primary Outcome(s)

Modified Mayo Score indicating remission [Time Frame: Week 12 and Week 24]

Secondary Outcome(s)

Modified Mayo Score indicating response [Time Frame: Week 12 and Week 24]

Secondary ID(s)

VB-201-064

Source(s) of Monetary Support

Please refer to primary and secondary sponsors