Overview

VE202 in Patients With Mild-to-Moderate Ulcerative Colitis

Status:
Not yet recruiting
Trial end date:
2025-02-01
Target enrollment:
0
Participant gender:
All
Summary
A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vedanta Biosciences, Inc.
Treatments:
Vancomycin
Criteria
KEY INCLUSION CRITERIA

1. 18 to 75 years of age

2. Documented clinical and endoscopic diagnosis of UC at least 3 months prior to
randomization

3. Active mild to moderate UC, as defined by the following:

1. Disease that extends at least 15 cm from the anal verge

2. A modified Mayo score of 4 to 8 with: (i.) Mayo endoscopic subscore of ≥ 2 based
on screening flexible sigmoidoscopy; (ii.) Rectal bleeding score of ≥ 1

4. Has never received a biologic agent, Janus kinase inhibitor, or
sphingosine-1-phosphate modulator for the treatment of UC

5. If receiving corticosteroids, dose must be stable for at least 4 weeks before
randomization

6. Doses of other allowable UC medications must be stable for at least 8 weeks before
randomization

KEY EXCLUSION CRITERIA

1. Known history of Crohn's disease (CD) or indeterminate colitis

2. A known diagnosis of primary sclerosing cholangitis

3. Allergy to VE202 or any of its components

4. Allergy to vancomycin or any of its components

5. A diagnosis of any non-IBD diarrheal illness (eg, Clostridioides difficile, celiac
disease, parasitic infection) within 3 months prior to randomization

6. Use of probiotics or herbal, botanical, or traditional medicinal preparations within
the 2 weeks prior to randomization (consumption of food products such as yogurt,
kefir, kombucha, and herbal teas is permissible)

7. Receipt of Fecal Microbiota Transplantation (FMT) or other fecal-derived preparation
within 6 months prior to randomization

8. Prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or
appendectomy)

9. Receipt of any investigational biologic within 60 days or 5 half-lives prior to
randomization, whichever is longer