NCT03759041

A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis

ECO-RESET: A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Seres Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults with Active Mild-to-Moderate Ulcerative Colitis

Detailed description

This is a Phase 2B randomized, double-blind, placebo-controlled, multiple dose, multicenter study designed to evaluate the efficacy, safety and microbiome alterations associated with two dose levels of SER-287, after pre-treatment with vancomycin, in adult subjects, age 18-80, with active mild-to-moderate ulcerative colitis (UC).

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Vancomycin Pre-Treatment	Four times per day dosing of vancomycin pre-treatment
DRUG	Placebo for Vancomycin Pre-Treatment	Four times per day dosing of placebo pre-treatment
DRUG	SER-287	Once-daily dosing of SER-287
DRUG	Placebo for SER-287	Once-daily dosing of Placebo for SER-287

Timeline

• Start date: 2018-12-19
• Primary completion: 2021-05-28
• Completion: 2021-10-13
• First posted: 2018-11-29
• Last updated: 2022-08-12
• Results posted: 2022-06-21

Locations

93 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study