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

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

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

Study Overview

• Status: Terminated
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Placebo for Vancomycin Pre-Treatment; Drug: Placebo for SER-287; Drug: Vancomycin Pre-Treatment; Drug: SER-287

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).

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2L7
      • (Investigator site)
    • Edmonton, Alberta, Canada, T6L 6K3
      • (Investigator site)
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W4
      • (Investigator site)
  • Ontario
    • Bridgewater, Ontario, Canada, B4V 3K9
      • (Investigator site)
    • Lindsay, Ontario, Canada, K9V 5G6
      • (Investigator site)
    • London, Ontario, Canada, N6A 5A5
      • (Investigator site)
    • London, Ontario, Canada, N6A 5W9
      • (Investigator site)
    • Sudbury, Ontario, Canada, P3C 5K6
      • (Investigator site)
    • Toronto, Ontario, Canada, M5T 3A9
      • (Investigator site)
    • Vaughan, Ontario, Canada, L4L 4Y7
      • (Investigator site)
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • (Investigator site)
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • (Investigator site)
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • (Investigator site)
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • (Investigator site)
  • California
    • La Jolla, California, United States, 92037
      • (Investigator site)
    • Lancaster, California, United States, 93534
      • (Investigator site)
    • Los Angeles, California, United States, 90067
      • (Investigator site)
    • Mountain View, California, United States, 94040
      • (Investigator site)
    • San Diego, California, United States, 92123
      • (Investigator site)
    • San Diego, California, United States, 92103
      • (Investigator site)
  • Colorado
    • Wheat Ridge, Colorado, United States, 80033
      • (Investigator site)
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • (Investigator site)
    • Hamden, Connecticut, United States, 06518
      • (Investigator site)
  • Florida
    • Boca Raton, Florida, United States, 33487
      • (Investigator site)
    • Clearwater, Florida, United States, 33762
      • (Investigator site)
    • Crystal River, Florida, United States, 34429
      • (Investigator site)
    • Fort Lauderdale, Florida, United States, 33308
      • (Investigator site)
    • Hialeah, Florida, United States, 33012
      • (Investigator site)
    • Jacksonville, Florida, United States, 32256
      • (Investigator site)
    • Miami, Florida, United States, 33136
      • (Investigator site)
    • Miami, Florida, United States, 33176
      • (Investigator site)
    • Naples, Florida, United States, 34102
      • (Investigator site)
    • Ocala, Florida, United States, 34474
      • (Investigator site)
    • Orlando, Florida, United States, 32803
      • (Investigator site)
    • Pompano Beach, Florida, United States, 33060
      • (Investigator site)
    • Port Orange, Florida, United States, 32127
      • (Investigator site)
    • Tampa, Florida, United States, 33609
      • (Investigator site)
  • Georgia
    • Athens, Georgia, United States, 30607
      • (Investigator site)
    • Atlanta, Georgia, United States, 30322
      • (Investigator site)
    • Marietta, Georgia, United States, 30060
      • (Investigator site)
  • Illinois
    • Chicago, Illinois, United States, 60637
      • (Investigator site)
    • Chicago, Illinois, United States, 60611
      • (Investigator site)
    • Chicago, Illinois, United States, 60612
      • (Investigator site)
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • (Investigator site)
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • (Investigator site)
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • (Investigator site)
    • Metairie, Louisiana, United States, 70006
      • (Investigator site)
    • Monroe, Louisiana, United States, 71201
      • (Investigator site)
    • New Orleans, Louisiana, United States, 70121
      • (Investigator site)
    • Shreveport, Louisiana, United States, 71105
      • (Investigator site)
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • (Investigator site)
    • Glen Burnie, Maryland, United States, 21208
      • (Investigator site)
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • (Investigator site)
    • Farmington Hills, Michigan, United States, 48334
      • (Investigator site)
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • (Investigator site)
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • (Investigator site)
    • Creve Coeur, Missouri, United States, 63141
      • (Investigator site)
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • (Investigator site)
    • Reno, Nevada, United States, 89511
      • (Investigator site)
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • (Investigator site)
  • New York
    • Great Neck, New York, United States, 11021
      • (Investigator site)
    • Hartsdale, New York, United States, 10530
      • (Investigator site)
    • New York, New York, United States, 10016
      • (Investigator site)
    • New York, New York, United States, 10032
      • (Investigator site)
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • (Investigator site)
    • Chapel Hill, North Carolina, United States, 27599
      • (Investigator site)
    • Durham, North Carolina, United States, 27710
      • (Investigator site)
    • Raleigh, North Carolina, United States, 27612
      • (Investigator site)
    • Winston-Salem, North Carolina, United States, 27103
      • (Investigator site)
    • Winston-Salem, North Carolina, United States, 27157
      • (Investigator site)
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • (Investigator site)
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • (Investigator site)
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • (Investigator site)
    • Greenville, South Carolina, United States, 29615
      • (Investigator site)
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • (Investigator site)
    • Nashville, Tennessee, United States, 37212
      • (Investigator site)
  • Texas
    • Bedford, Texas, United States, 76022
      • (Investigator site)
    • Fort Sam Houston, Texas, United States, 78219
      • (Investigator site)
    • Houston, Texas, United States, 77030
      • (Investigator site)
    • Houston, Texas, United States, 77043
      • (Investigator site)
    • Houston, Texas, United States, 77090
      • (Investigator site)
    • McAllen, Texas, United States, 78504
      • (Investigator site)
    • San Antonio, Texas, United States, 78229
      • (Investigator site)
    • Temple, Texas, United States, 76508
      • (Investigator site)
  • Utah
    • Ogden, Utah, United States, 84405
      • (Investigator site)
    • Salt Lake City, Utah, United States, 84124
      • (Investigator site)
  • Virginia
    • Leesburg, Virginia, United States, 20176
      • (Investigator site)
    • Lynchburg, Virginia, United States, 24502
      • (Investigator site)
    • Reston, Virginia, United States, 20191
      • (Investigator site)
    • Richmond, Virginia, United States, 23249
      • (Investigator site)
  • Washington
    • Spokane, Washington, United States, 99202
      • (Investigator site)
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • (Investigator site)
    • Milwaukee, Wisconsin, United States, 53215
      • (Investigator site)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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-TNFα, 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo (after placebo pre-treatment); Once-daily dosing of Placebo (after placebo pre-treatment)	Drug: Placebo for Vancomycin Pre-Treatment; Four times per day dosing of placebo pre-treatment; Drug: Placebo for SER-287; Once-daily dosing of Placebo for SER-287
Experimental: SER-287 Induction Dosing (after vancomycin pre-treatment); Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)	Drug: Vancomycin Pre-Treatment; Four times per day dosing of vancomycin pre-treatment; Drug: SER-287; Once-daily dosing of SER-287; Other Names: Eubacterial Spores, Purified Suspension, Encapsulated
Experimental: SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment); Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)	Drug: Vancomycin Pre-Treatment; Four times per day dosing of vancomycin pre-treatment; Drug: SER-287; Once-daily dosing of SER-287; Other Names: Eubacterial Spores, Purified Suspension, Encapsulated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Seres Therapeutics, Inc.
• Investigators: Study Director: Lisa von Moltke, MD, Seres Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2018
• Primary Completion (Actual): May 28, 2021
• Study Completion (Actual): October 13, 2021

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 12, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: microbiome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: SERES-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No