Study Stopped
Due to the lack of a clinical efficacy signal in the induction treatment phase, Seres closed the dosing phases of open label and maintenance portions of the study. Patients who had received prior doses were followed for safety data.
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
1 other identifier
interventional
203
2 countries
93
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2018
Typical duration for phase_2
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2018
CompletedFirst Posted
Study publicly available on registry
November 29, 2018
CompletedStudy Start
First participant enrolled
December 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2021
CompletedResults Posted
Study results publicly available
June 21, 2022
CompletedAugust 12, 2022
July 1, 2022
2.4 years
November 27, 2018
May 24, 2022
July 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Endoscopic Improvement (Count of Participants)
After 10 weeks of induction dosing
Study Arms (3)
Placebo (after placebo pre-treatment)
PLACEBO COMPARATOROnce-daily dosing of Placebo (after placebo pre-treatment)
SER-287 Induction Dosing (after vancomycin pre-treatment)
EXPERIMENTALOnce-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)
SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment)
EXPERIMENTALOnce-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)
Interventions
Four times per day dosing of vancomycin pre-treatment
Four times per day dosing of placebo pre-treatment
Once-daily dosing of SER-287
Once-daily dosing of Placebo for SER-287
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Known history of Crohn's disease
- No previous history of treatment for UC (treatment-naĂ¯ve)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (93)
(Investigator site)
Phoenix, Arizona, 85018, United States
(Investigator site)
North Little Rock, Arkansas, 72117, United States
(Investigator site)
La Jolla, California, 92037, United States
(Investigator site)
Lancaster, California, 93534, United States
(Investigator site)
Los Angeles, California, 90067, United States
(Investigator site)
Mountain View, California, 94040, United States
(Investigator site)
San Diego, California, 92103, United States
(Investigator site)
San Diego, California, 92123, United States
(Investigator site)
Wheat Ridge, Colorado, 80033, United States
(Investigator site)
Danbury, Connecticut, 06810, United States
(Investigator site)
Hamden, Connecticut, 06518, United States
(Investigator site)
Boca Raton, Florida, 33487, United States
(Investigator site)
Clearwater, Florida, 33762, United States
(Investigator site)
Crystal River, Florida, 34429, United States
(Investigator site)
Fort Lauderdale, Florida, 33308, United States
(Investigator site)
Hialeah, Florida, 33012, United States
(Investigator site)
Jacksonville, Florida, 32256, United States
(Investigator site)
Miami, Florida, 33136, United States
(Investigator site)
Miami, Florida, 33176, United States
(Investigator site)
Naples, Florida, 34102, United States
(Investigator site)
Ocala, Florida, 34474, United States
(Investigator site)
Orlando, Florida, 32803, United States
(Investigator site)
Pompano Beach, Florida, 33060, United States
(Investigator site)
Port Orange, Florida, 32127, United States
(Investigator site)
Tampa, Florida, 33609, United States
(Investigator site)
Athens, Georgia, 30607, United States
(Investigator site)
Atlanta, Georgia, 30322, United States
(Investigator site)
Marietta, Georgia, 30060, United States
(Investigator site)
Chicago, Illinois, 60611, United States
(Investigator site)
Chicago, Illinois, 60612, United States
(Investigator site)
Chicago, Illinois, 60637, United States
(Investigator site)
Indianapolis, Indiana, 46202, United States
(Investigator site)
Lexington, Kentucky, 40536, United States
(Investigator site)
Lake Charles, Louisiana, 70601, United States
(Investigator site)
Metairie, Louisiana, 70006, United States
(Investigator site)
Monroe, Louisiana, 71201, United States
(Investigator site)
New Orleans, Louisiana, 70121, United States
(Investigator site)
Shreveport, Louisiana, 71105, United States
(Investigator site)
Baltimore, Maryland, 21287, United States
(Investigator site)
Glen Burnie, Maryland, 21208, United States
(Investigator site)
Ann Arbor, Michigan, 48109, United States
(Investigator site)
Farmington Hills, Michigan, 48334, United States
(Investigator site)
Rochester, Minnesota, 55905, United States
(Investigator site)
Bridgeton, Missouri, 63044, United States
(Investigator site)
Creve Coeur, Missouri, 63141, United States
(Investigator site)
Las Vegas, Nevada, 89123, United States
(Investigator site)
Reno, Nevada, 89511, United States
(Investigator site)
Lebanon, New Hampshire, 03756, United States
(Investigator site)
Great Neck, New York, 11021, United States
(Investigator site)
Hartsdale, New York, 10530, United States
(Investigator site)
New York, New York, 10016, United States
(Investigator site)
New York, New York, 10032, United States
(Investigator site)
Asheville, North Carolina, 28801, United States
(Investigator site)
Chapel Hill, North Carolina, 27599, United States
(Investigator site)
Durham, North Carolina, 27710, United States
(Investigator site)
Raleigh, North Carolina, 27612, United States
(Investigator site)
Winston-Salem, North Carolina, 27103, United States
(Investigator site)
Winston-Salem, North Carolina, 27157, United States
(Investigator site)
Cincinnati, Ohio, 45219, United States
(Investigator site)
Oklahoma City, Oklahoma, 73104, United States
(Investigator site)
Columbia, South Carolina, 29203, United States
(Investigator site)
Greenville, South Carolina, 29615, United States
(Investigator site)
Memphis, Tennessee, 38119, United States
(Investigator site)
Nashville, Tennessee, 37212, United States
(Investigator site)
Bedford, Texas, 76022, United States
(Investigator site)
Fort Sam Houston, Texas, 78219, United States
(Investigator site)
Houston, Texas, 77030, United States
(Investigator site)
Houston, Texas, 77043, United States
(Investigator site)
Houston, Texas, 77090, United States
(Investigator site)
McAllen, Texas, 78504, United States
(Investigator site)
San Antonio, Texas, 78229, United States
(Investigator site)
Temple, Texas, 76508, United States
(Investigator site)
Ogden, Utah, 84405, United States
(Investigator site)
Salt Lake City, Utah, 84124, United States
(Investigator site)
Leesburg, Virginia, 20176, United States
(Investigator site)
Lynchburg, Virginia, 24502, United States
(Investigator site)
Reston, Virginia, 20191, United States
(Investigator site)
Richmond, Virginia, 23249, United States
(Investigator site)
Spokane, Washington, 99202, United States
(Investigator site)
Madison, Wisconsin, 53792, United States
(Investigator site)
Milwaukee, Wisconsin, 53215, United States
(Investigator site)
Edmonton, Alberta, T6G 2L7, Canada
(Investigator site)
Edmonton, Alberta, T6L 6K3, Canada
(Investigator site)
New Westminster, British Columbia, V3L 3W4, Canada
(Investigator site)
Bridgewater, Ontario, B4V 3K9, Canada
(Investigator site)
Greater Sudbury, Ontario, P3C 5K6, Canada
(Investigator site)
Lindsay, Ontario, K9V 5G6, Canada
(Investigator site)
London, Ontario, N6A 5A5, Canada
(Investigator site)
London, Ontario, N6A 5W9, Canada
(Investigator site)
Toronto, Ontario, M5T 3A9, Canada
(Investigator site)
Vaughan, Ontario, L4L 4Y7, Canada
(Investigator site)
Greenfield Park, Quebec, J4V 2H1, Canada
(Investigator site)
Saskatoon, Saskatchewan, S7N 0W8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lisa von Moltke, MD, Chief Medical Officer
- Organization
- Seres Therapeutics
Study Officials
- STUDY DIRECTOR
Lisa von Moltke, MD
Seres Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2018
First Posted
November 29, 2018
Study Start
December 19, 2018
Primary Completion
May 28, 2021
Study Completion
October 13, 2021
Last Updated
August 12, 2022
Results First Posted
June 21, 2022
Record last verified: 2022-07