Study of VE202 in Patients with mild to moderate Ulcerative Colitis
Research type
Research Study
Full title
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients with Mild-to-Moderate Ulcerative Colitis
IRAS ID
1005942
Contact name
Anne Kuan
Contact email
Sponsor organisation
Vedanta Biosciences, Inc.
Eudract number
2021-001280-24
Clinicaltrials.gov Identifier
Research summary
Patients with ulcerative colitis often have an abnormal balance of bacteria in their colon. This study will investigate whether an investigational drug, VE202, can correct this imbalance and to understand how VE202 works and how the body reacts; patients aged 18-75 years may be eligible. The study has 3 parts, plus Screening which allows the study doctors to know how active the patient's ulcerative colitis is at the beginning of the study. Following screening, study patients will be randomised (selected by chance) to one of two groups. During the study, patients will receive both VE202 and placebo, but at different times (one in Part 1 and the other in Part 2). The placebo is a capsule that looks like VE202 but does not contain any active substance. The study patient and their doctor will not know which group the patient is allocated to or whether they are receiving VE202 or placebo. In Part 1, patients will take 5 days of an approved antibiotic called vancomycin, followed by 56 days of VE202 or placebo (10 capsules per day for 14 days and then 1 capsule per day). In Part 2, patients in the group that received placebo in Part 1 of the study will receive 5 days of vancomycin followed by 14 days of VE202 in Part 2; Patients in the group that receives VE202 in Part 1 will receive 5 days of a vancomycin placebo followed by 14 days of VE202 placebo in Part 2. In Part 3 study patients will not take any more study medication (VE202, vancomycin, or placebo), but the study doctor will collect information about their health to understand the long-term safety of VE202. During the study, tests will be completed, including blood, urine, stool samples, sigmoidoscopy (an examination used to evaluate the lower part of the colon using a thin, flexible tube inserted into the rectum), questionnaires, and a diary. There will be approximately 17 study visits over approximately 56 weeks.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0298
Date of REC Opinion
11 Jul 2023
REC opinion
Further Information Favourable Opinion