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

Ulcerative Colitis Clinical Trial

— ECO-RESET  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03759041
• Other study ID #: SERES-201
• Status: Terminated
• Phase: Phase 2
• Start date: December 19, 2018
• Est. completion date: October 13, 2021

Study information

• Verified date: July 2022
• Source: Seres Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 203
• Est. completion date: October 13, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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-TNFa, anti-integrin or tofacitinib

Exclusion Criteria:

• Known history of Crohn's disease

• No previous history of treatment for UC (treatment-naïve)

• 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Vancomycin Pre-Treatment
Four times per day dosing of vancomycin pre-treatment
• Placebo for Vancomycin Pre-Treatment
Four times per day dosing of placebo pre-treatment
• SER-287
Once-daily dosing of SER-287
• Placebo for SER-287
Once-daily dosing of Placebo for SER-287

Locations

Country	Name	City	State
Canada	(Investigator site)	Bridgewater	Ontario
Canada	(Investigator site)	Edmonton	Alberta
Canada	(Investigator site)	Edmonton	Alberta
Canada	(Investigator site)	Greenfield Park	Quebec
Canada	(Investigator site)	Lindsay	Ontario
Canada	(Investigator site)	London	Ontario
Canada	(Investigator site)	London	Ontario
Canada	(Investigator site)	New Westminster	British Columbia
Canada	(Investigator site)	Saskatoon	Saskatchewan
Canada	(Investigator site)	Sudbury	Ontario
Canada	(Investigator site)	Toronto	Ontario
Canada	(Investigator site)	Vaughan	Ontario
United States	(Investigator site)	Ann Arbor	Michigan
United States	(Investigator site)	Asheville	North Carolina
United States	(Investigator site)	Athens	Georgia
United States	(Investigator site)	Atlanta	Georgia
United States	(Investigator site)	Baltimore	Maryland
United States	(Investigator site)	Bedford	Texas
United States	(Investigator site)	Boca Raton	Florida
United States	(Investigator site)	Bridgeton	Missouri
United States	(Investigator site)	Chapel Hill	North Carolina
United States	(Investigator site)	Chicago	Illinois
United States	(Investigator site)	Chicago	Illinois
United States	(Investigator site)	Chicago	Illinois
United States	(Investigator site)	Cincinnati	Ohio
United States	(Investigator site)	Clearwater	Florida
United States	(Investigator site)	Columbia	South Carolina
United States	(Investigator site)	Creve Coeur	Missouri
United States	(Investigator site)	Crystal River	Florida
United States	(Investigator site)	Danbury	Connecticut
United States	(Investigator site)	Durham	North Carolina
United States	(Investigator site)	Farmington Hills	Michigan
United States	(Investigator site)	Fort Lauderdale	Florida
United States	(Investigator site)	Fort Sam Houston	Texas
United States	(Investigator site)	Glen Burnie	Maryland
United States	(Investigator site)	Great Neck	New York
United States	(Investigator site)	Greenville	South Carolina
United States	(Investigator site)	Hamden	Connecticut
United States	(Investigator site)	Hartsdale	New York
United States	(Investigator site)	Hialeah	Florida
United States	(Investigator site)	Houston	Texas
United States	(Investigator site)	Houston	Texas
United States	(Investigator site)	Houston	Texas
United States	(Investigator site)	Indianapolis	Indiana
United States	(Investigator site)	Jacksonville	Florida
United States	(Investigator site)	La Jolla	California
United States	(Investigator site)	Lake Charles	Louisiana
United States	(Investigator site)	Lancaster	California
United States	(Investigator site)	Las Vegas	Nevada
United States	(Investigator site)	Lebanon	New Hampshire
United States	(Investigator site)	Leesburg	Virginia
United States	(Investigator site)	Lexington	Kentucky
United States	(Investigator site)	Los Angeles	California
United States	(Investigator site)	Lynchburg	Virginia
United States	(Investigator site)	Madison	Wisconsin
United States	(Investigator site)	Marietta	Georgia
United States	(Investigator site)	McAllen	Texas
United States	(Investigator site)	Memphis	Tennessee
United States	(Investigator site)	Metairie	Louisiana
United States	(Investigator site)	Miami	Florida
United States	(Investigator site)	Miami	Florida
United States	(Investigator site)	Milwaukee	Wisconsin
United States	(Investigator site)	Monroe	Louisiana
United States	(Investigator site)	Mountain View	California
United States	(Investigator site)	Naples	Florida
United States	(Investigator site)	Nashville	Tennessee
United States	(Investigator site)	New Orleans	Louisiana
United States	(Investigator site)	New York	New York
United States	(Investigator site)	New York	New York
United States	(Investigator site)	North Little Rock	Arkansas
United States	(Investigator site)	Ocala	Florida
United States	(Investigator site)	Ogden	Utah
United States	(Investigator site)	Oklahoma City	Oklahoma
United States	(Investigator site)	Orlando	Florida
United States	(Investigator site)	Phoenix	Arizona
United States	(Investigator site)	Pompano Beach	Florida
United States	(Investigator site)	Port Orange	Florida
United States	(Investigator site)	Raleigh	North Carolina
United States	(Investigator site)	Reno	Nevada
United States	(Investigator site)	Reston	Virginia
United States	(Investigator site)	Richmond	Virginia
United States	(Investigator site)	Rochester	Minnesota
United States	(Investigator site)	Salt Lake City	Utah
United States	(Investigator site)	San Antonio	Texas
United States	(Investigator site)	San Diego	California
United States	(Investigator site)	San Diego	California
United States	(Investigator site)	Shreveport	Louisiana
United States	(Investigator site)	Spokane	Washington
United States	(Investigator site)	Tampa	Florida
United States	(Investigator site)	Temple	Texas
United States	(Investigator site)	Wheat Ridge	Colorado
United States	(Investigator site)	Winston-Salem	North Carolina
United States	(Investigator site)	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Seres Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Remission (Count of Participants)	Clinical remission for the induction treatment period: Stool Frequency subscore = 0 or 1, with at least 1-point decrease from baseline; Rectal Bleeding subscore = 0; Endoscopic subscore = 0 or 1 on modified Mayo Score, with at least 1-point decrease from baseline; No occurrence of UC Flare during the treatment period; Clinical remission was measured using 3 components of the modified Mayo Score (stool frequency, rectal bleeding and endoscopic subscore), a measure of UC disease activity. These 3 components are each graded from 0 to 3, and are summed together for a composite score, with a higher overall score indicating more severe disease (0 = no disease; 9 = worst disease). The modified Mayo endoscopic subscore excludes friability from an endoscopic subscore of 1.	After 10 weeks of induction dosing
Secondary	Endoscopic Improvement (Count of Participants)	Endoscopic subscore decrease from baseline of at least 1 point, as assessed by flexible sigmoidoscopy or colonoscopy.; Endoscopic improvement was measured using the modified Mayo Score endoscopic subscore, graded from 0 to 3, with higher scores indicating more severe disease. The modified Mayo endoscopic subscore excludes friability from an endoscopic subscore of 1.	After 10 weeks of induction dosing