NCT05370885

VE202 in Patients With Mild-to-Moderate Ulcerative Colitis

Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients With Mild-to-Moderate Ulcerative Colitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Vedanta Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 the study, patients will receive VE202 or placebo for 8 weeks or 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.

Conditions

• Ulcerative Colitis
• Colitis, Ulcerative

Interventions

Type	Name	Description
BIOLOGICAL	VE202	VE202 is a rationally defined, live biotherapeutic product for oral administration.
DRUG	Vancomycin Oral Capsule	Vancomycin is an antibiotic used to treat or prevent infection
OTHER	VE202 Placebo	VE202 Placebo
OTHER	Vancomycin Placebo	Vancomycin Placebo

Timeline

• Start date: 2023-05-08
• Primary completion: 2025-08-29
• Completion: 2025-08-29
• First posted: 2022-05-12
• Last updated: 2025-12-17

Locations

49 sites across 10 countries: United States, Australia, Bulgaria, Czechia, Hungary, Lithuania, Netherlands, Poland, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study