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

NCT03759041 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2022-08-12

Study results available
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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

Conditions

Interventions

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

Sponsors & Collaborators

  • Seres Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Lisa von Moltke, MD · Seres Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2021-05-28
Completion
2021-10-13
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03759041 on ClinicalTrials.gov