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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 : January 4, 2019
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)
Estimated Enrollment : 201 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
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Vancomycin

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo (after placebo pre-treat.)
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 vanco. pre-treat.)
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 vanco. pre-treat.)
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 [ Time Frame: After 10 weeks of induction dosing ]

Secondary Outcome Measures :
  1. Endoscopic Improvement [ Time Frame: After 10 weeks of induction dosing ]
    Endoscopic subscore (modified Mayo Score) decrease from baseline of at least one point


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


Contacts
Contact: Sherry Weigand, MD, PhD 617-203-3492 clinicalstudies@serestherapeutics.com

Locations
United States, North Carolina
Asheville Gastroenterology Associates, P.A. Recruiting
Asheville, North Carolina, United States, 28801
Contact: Golden         
Sponsors and Collaborators
Seres Therapeutics, Inc.
Investigators
Study Director: Sherry Weigand, MD, PhD Seres Therapeutics, Inc.
More Information
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Responsible Party: Seres Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03759041     History of Changes
Other Study ID Numbers: SERES-201
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019

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:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
 Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents