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

Primary Purpose

Ulcerative Colitis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vancomycin Pre-Treatment
Placebo for Vancomycin Pre-Treatment
SER-287
Placebo for SER-287
Sponsored by
Seres Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring microbiome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo (after placebo pre-treatment)

SER-287 Induction Dosing (after vancomycin pre-treatment)

SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment)

Arm Description

Once-daily dosing of Placebo (after placebo pre-treatment)

Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)

Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 27, 2018
Last Updated
July 19, 2022
Sponsor
Seres Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03759041
Brief Title
A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
December 19, 2018 (Actual)
Primary Completion Date
May 28, 2021 (Actual)
Study Completion Date
October 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seres Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
microbiome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo (after placebo pre-treatment)
Arm Type
Placebo Comparator
Arm Description
Once-daily dosing of Placebo (after placebo pre-treatment)
Arm Title
SER-287 Induction Dosing (after vancomycin pre-treatment)
Arm Type
Experimental
Arm Description
Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)
Arm Title
SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment)
Arm Type
Experimental
Arm Description
Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)
Intervention Type
Drug
Intervention Name(s)
Vancomycin Pre-Treatment
Intervention Description
Four times per day dosing of vancomycin pre-treatment
Intervention Type
Drug
Intervention Name(s)
Placebo for Vancomycin Pre-Treatment
Intervention Description
Four times per day dosing of placebo pre-treatment
Intervention Type
Drug
Intervention Name(s)
SER-287
Other Intervention Name(s)
Eubacterial Spores, Purified Suspension, Encapsulated
Intervention Description
Once-daily dosing of SER-287
Intervention Type
Drug
Intervention Name(s)
Placebo for SER-287
Intervention Description
Once-daily dosing of Placebo for SER-287
Primary Outcome Measure Information:
Title
Clinical Remission (Count of Participants)
Description
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.
Time Frame
After 10 weeks of induction dosing
Secondary Outcome Measure Information:
Title
Endoscopic Improvement (Count of Participants)
Description
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.
Time Frame
After 10 weeks of induction dosing

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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