Status:
TERMINATED
VE202 in Patients With Mild-to-Moderate Ulcerative Colitis
Lead Sponsor:
Vedanta Biosciences, Inc.
Conditions:
Ulcerative Colitis
Colitis, Ulcerative
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).
Detailed Description
A Phase 2 double-blind, placebo-controlled, randomized study to evaluate the safety, efficacy, and microbiota changes of VE202 in biologic-naïve patients with mild to moderate UC. In Parts 1 and 2 of ...
Eligibility Criteria
Inclusion
- KEY INCLUSION CRITERIA
- 18 to 75 years of age
- Documented clinical and endoscopic diagnosis of UC at least 3 months prior to randomization
- Active mild to moderate UC, as defined by the following:
- Disease that extends at least 15 cm from the anal verge
- 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
- Has never received a biologic agent, Janus kinase inhibitor, or sphingosine-1-phosphate modulator for the treatment of UC
- If receiving corticosteroids, dose must be stable for at least 4 weeks before randomization
- Doses of other allowable UC medications must be stable for at least 8 weeks before randomization
- KEY EXCLUSION CRITERIA
- Known history of Crohn's disease (CD) or indeterminate colitis
- A known diagnosis of primary sclerosing cholangitis
- Allergy to VE202 or any of its components
- Allergy to vancomycin or any of its components
- A diagnosis of any non-IBD diarrheal illness (eg, Clostridioides difficile, celiac disease, parasitic infection) within 3 months prior to randomization
- 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)
- Receipt of Fecal Microbiota Transplantation (FMT) or other fecal-derived preparation within 6 months prior to randomization
- Prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or appendectomy)
- Receipt of any investigational biologic within 60 days or 5 half-lives prior to randomization, whichever is longer
Exclusion
Key Trial Info
Start Date :
May 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2025
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT05370885
Start Date
May 8 2023
End Date
August 29 2025
Last Update
December 17 2025
Active Locations (49)
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1
GI Pros Research
Naples, Florida, United States, 34102
2
Revival Clinical Research
Orlando, Florida, United States, 32807
3
Atlanta Center for Gastroenterology, P.C. & Atlanta Endoscopy Center, LTD
Decatur, Georgia, United States, 30033-6146
4
Boston Medical Center
Boston, Massachusetts, United States, 02118