drugset

drugset / Trial / NCT05370885

VE202 in Patients With Mild-to-Moderate Ulcerative Colitis

NCT05370885 ↗

Phase 2 Terminated 114 enrolled Vedanta Biosciences, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).

Timeline

Start: 2023-05-08
Primary completion: 2025-08-29
Completion: 2025-08-29

Publications

Silber JL, Norman JM, Kanno T, Crossette EM, Szabady R, Menon R, Marko M, Hao LY, Tomsho L, Bhagat S, Yuan A, Olle B, Lamouse-Smith E. A randomized, double-blind, placebo-controlled, single- and multiple-dose phase 1 study of VE202, a defined bacterial consortium for treatment of inflammatory bowel disease: safety and colonization dynamics of a novel live biotherapeutic product in healthy adults. Eur J Gastroenterol Hepatol. 2026 Apr 1;38(4):437-441. doi: 10.1097/MEG.0000000000003098. Epub 2025 Oct 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	VE202	Other / unclassified	—	Oral
Background	Vancomycin	Other / unclassified	—	Oral

Indications