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

  • STATUS
    Recruiting
  • End date
    Aug 23, 2021
  • participants needed
    201
  • sponsor
    Seres Therapeutics, Inc.
Updated on 23 February 2020
Investigator
Michele Trucksis, PhD, MD
Primary Contact
(Investigator site) (4.3 mi away) Contact
+92 other location
corticosteroids
mercaptopurine
azathioprine
tumor necrosis factor alpha
mesalamine

Summary

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER287 in Adults with Active Mild-to-Moderate Ulcerative Colitis

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).

Details
Treatment Vancomycin Pre-Treatment, Placebo for Vancomycin Pre-Treatment, SER-287, Placebo for SER-287
Clinical Study IdentifierNCT03759041
SponsorSeres Therapeutics, Inc.
Last Modified on23 February 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Ulcerative Colitis or Ulcerative Colitis (Pediatric)?
Documented diagnosis of UC at least three months prior to screening, and with a minimum disease extent of 15 cm from the anal verge
Active mild-to-moderate UC
Inadequate response to, loss of response to, or intolerance of, at least one of the following conventional therapies: 5-ASA compounds, corticosteroids, 6-mercaptopurine (6-MP) or azathioprine (AZA), anti-TNF, anti-integrin or tofacitinib

Exclusion Criteria

Known history of Crohn's disease
No previous history of treatment for UC (treatment-nave)
Subjects on steroid medication who are unable to have steroids tapered and be completely off steroids at least two weeks prior to screening
Unable to stop steroid enemas or suppositories, or 5-ASA enemas or suppositories, at least two weeks prior to screening
Subjects who have received any investigational or approved biologic therapy within eight weeks or five half-lives prior to screening (whichever is longer)
Subjects who have received any investigational or approved non-biologic therapy, except for those specifically listed in the Permitted Concomitant Medications, for the treatment of underlying disease, within 30 days or five half-lives prior to screening (whichever is longer)
Major gastrointestinal surgery (not including appendectomy or cholecystectomy) within two months before screening, or any history of total colectomy
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