drugset / Trial / NCT06237452

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

NCT06237452

Phase 3 Recruiting 852 enrolled Vedanta Biosciences, Inc.
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).

Timeline

Start
2024-05-20
Primary completion
2027-06
Completion
2027-10

Drugs

EvaluationDrugModalityDoseRoute
Subject VE303 Other / unclassified