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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03759041
Recruitment Status : Terminated (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.)
First Posted : November 29, 2018
Results First Posted : June 21, 2022
Last Update Posted : August 12, 2022
Sponsor:
Information provided by (Responsible Party):
Seres Therapeutics, Inc.

Study Description
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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

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Vancomycin Pre-Treatment Drug: Placebo for Vancomycin Pre-Treatment Drug: SER-287 Drug: Placebo for SER-287 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 19, 2018
Actual Primary Completion Date : May 28, 2021
Actual Study Completion Date : October 13, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Eubacterial Spores, Purified Suspension, Encapsulated


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Remission (Count of Participants) [ Time Frame: After 10 weeks of induction dosing ]

    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 :
  1. Endoscopic Improvement (Count of Participants) [ Time Frame: After 10 weeks of induction dosing ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759041


Locations
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Sponsors and Collaborators
Seres Therapeutics, Inc.
Investigators
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Study Director: Lisa von Moltke, MD Seres Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Seres Therapeutics, Inc.:
Study Protocol  [PDF] October 8, 2019
Statistical Analysis Plan: Clinical SAP  [PDF] April 21, 2021
Statistical Analysis Plan: Microbiome SAP  [PDF] April 27, 2021

More Information
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Responsible Party: Seres Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03759041    
Other Study ID Numbers: SERES-201
First Posted: November 29, 2018    Key Record Dates
Results First Posted: June 21, 2022
Last Update Posted: August 12, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seres Therapeutics, Inc.:
microbiome
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
 Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents