colon inflammation disease inflammatory bowel disease
Conditions
Interventions
Investigational product, dosage and mode of administration:
Study patients will be randomized in a 1:1 ratio to Group A or Group B after
all screening criteria are
met. Upon successful completion of
Sponsors
Vedanta Biosciences, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Active mild to moderate UC, as defined by the following: * Disease that extends at least 15 cm from the anal verge * Modified Mayo score of 4 to 8 * Mayo endoscopic subscore as follows, based on screening flexible sigmoidoscopy: i. Subscore of >2 * Rectal bleeding score of >= -1 2. May be on corticosteroids, maximum dose of 10 mg QD prednisone (or prednisone equivalent) or budesonide 9 mg QD, if dose is stable for at least 4 weeks 3. Other allowable medications (eg, mesalamine, 6-mercaptopurine) at a stable dose for at least 8 weeks 4. Naïve to biologics - and Janus kinase inhibitor and sphingosine-1-phosphate modulators
Exclusion criteria
Exclusion criteria: A diagnosis of any non-IBD diarrheal illness . A diagnosis of primary sclerosing cholangitis Allergy to VE202 or vancomycin or any of their components . Use of systemic or non-absorbable oral antibiotics within the prior 4 weeks before randomization or anticipated within the study period . Use of probiotics within the prior 2 weeks (consumption of yogurt and kefir are permissible) . Active colonic dysplasia . Presence of adenomatous polyp on screening endoscopy, or history of adenomatous polyps that were not removed . Pregnant or lactating female
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endoscopic response rate defined as a reduction of 1 point or more in Mayo endoscopic subscore on flexible sigmoidoscopy from baseline to Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Clinical response • Clinical remission • Mean change in modified Mayo score • Proportion of patients with decrease of at least 1 point and at least 2 points in total Mayo score • Endoscopic remission • Change in each component of the total Mayo score • Histologic change in colonic biopsy as measured by Geboes score and (RHI) • Histologic response (Geboes score = 7 points or >= 50%) • Histologic remission (Geboes score | — |
Countries
Netherlands
Outcome results
None listed