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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)

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ClinicalTrials.gov Identifier: NCT03759041
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Seres Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE November 27, 2018
First Posted Date  ICMJE November 29, 2018
Last Update Posted Date November 13, 2019
Actual Study Start Date  ICMJE December 19, 2018
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2018)
Clinical Remission [ Time Frame: After 10 weeks of induction dosing ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03759041 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2018)
Endoscopic Improvement [ Time Frame: After 10 weeks of induction dosing ]
Endoscopic subscore (modified Mayo Score) decrease from baseline of at least one point
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess Efficacy and Safety of SER‑287 in Adults With Active Mild-to-Moderate Ulcerative Colitis
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Drug: Vancomycin Pre-Treatment
    Four times per day dosing of vancomycin pre-treatment
  • Drug: Placebo for Vancomycin Pre-Treatment
    Four times per day dosing of placebo pre-treatment
  • Drug: SER-287
    Once-daily dosing of SER-287
    Other Name: Eubacterial Spores, Purified Suspension, Encapsulated
  • Drug: Placebo for SER-287
    Once-daily dosing of Placebo for SER-287
Study Arms  ICMJE
  • Placebo Comparator: Placebo (after placebo pre-treat.)
    Once-daily dosing of Placebo (after placebo pre-treatment)
    Interventions:
    • Drug: Placebo for Vancomycin Pre-Treatment
    • Drug: Placebo for SER-287
  • Experimental: SER-287 Induction Dosing (after vanco. pre-treat.)
    Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)
    Interventions:
    • Drug: Vancomycin Pre-Treatment
    • Drug: SER-287
  • Experimental: SER-287 Step-Down Induction Dosing (after vanco. pre-treat.)
    Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)
    Interventions:
    • Drug: Vancomycin Pre-Treatment
    • Drug: SER-287
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 28, 2018)
201
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sherry Weigand, MD, PhD 617-203-3492 clinicalstudies@serestherapeutics.com
Contact: https://www.eco-resetstudy.com/#!/
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03759041
Other Study ID Numbers  ICMJE SERES-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seres Therapeutics, Inc.
Study Sponsor  ICMJE Seres Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sherry Weigand, MD, PhD Seres Therapeutics, Inc.
PRS Account Seres Therapeutics, Inc.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP