ECOSPOR IV: An Open-Label Extension of Study SERES-012 and Open-Label Program for Evaluating SER-109 in Subjects With Recurrent Clostridioides Difficile Infection (RCDI) (ECOSPORIV)
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ClinicalTrials.gov Identifier: NCT03183141 |
Recruitment Status :
Recruiting
First Posted : June 9, 2017
Last Update Posted : August 21, 2020
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Tracking Information | |||||||||
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First Submitted Date ICMJE | June 8, 2017 | ||||||||
First Posted Date ICMJE | June 9, 2017 | ||||||||
Last Update Posted Date | August 21, 2020 | ||||||||
Actual Study Start Date ICMJE | October 23, 2017 | ||||||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | ECOSPOR IV: An Open-Label Extension of Study SERES-012 and Open-Label Program for Evaluating SER-109 in Subjects With Recurrent Clostridioides Difficile Infection (RCDI) | ||||||||
Official Title ICMJE | ECOSPOR IV: An Open-Label Extension of Study SERES-012 and Open-Label Program for Evaluating SER-109 in Subjects With Recurrent Clostridioides Difficile Infection (RCDI) | ||||||||
Brief Summary | Cohort 1: Subjects who had a CDI recurrence in study SERES-012 within 8 weeks of receipt of study drug will be eligible. The purpose of this cohort is to assess safety and efficacy of SER-109 in reducing recurrence of Clostridioides difficile infection (CDI) in adults who had a CDI recurrence within 8 weeks after receipt of SER-109 or Placebo in study SERES-012. Cohort 2: Cohort 2 is an open-label program for subjects who were not part of SERES-012. The purpose of this cohort is to describe safety and tolerability of SER-109 in subjects 18 years of age or older with at least a first recurrence of CDI within the past 12 months. |
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Detailed Description | Cohort 1 is an open-label extension of study SERES-012. Subjects who had a CDI recurrence in study SERES-012 within 8 weeks of receipt of study drug, have responded to a course of standard of care (SOC) antibiotic treatment, and who have completed their SERES-012 Week 8 visit will receive an oral dose of SER-109. A treatment regimen of SER-109 is defined as an oral dose of SER-109 (4 capsules once daily) for 3 consecutive days. Approximately 30 eligible subjects with recurrent CDI disease from study SERES-012 are expected to enroll. Screening for this study will begin at the Week 8 Visit of study SERES-012. Cohort 2 is an open-label program for subjects who were not part of SERES-012. Subjects 18 years of age or older who had one or more CDI recurrence within 12 months and have responded to a course of SOC antibiotic treatment will receive an oral dose of SER-109. The CDI recurrence must be confirmed by a positive C. difficile stool toxin assay. A treatment regimen of SER-109 is defined as an oral dose of SER-109 (4 capsules once daily) for 3 consecutive days. Approximately 195 eligible subjects with recurrent CDI disease are expected to enroll. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Clostridioides Difficile Infection | ||||||||
Intervention ICMJE | Drug: SER-109
SER -109 is an ecology of bacteria in spore form, enriched from stool donations obtained from healthy, screened donors
Other Name: Eubacterial Spores, Purified Suspension, Encapsulated
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Study Arms ICMJE | Experimental: SER-109
SER -109 is an ecology of bacteria in spore form, enriched from stool donations obtained from healthy, screened donors
Intervention: Drug: SER-109
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
225 | ||||||||
Original Estimated Enrollment ICMJE |
100 | ||||||||
Estimated Study Completion Date ICMJE | April 2022 | ||||||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Cohort 1 Inclusion Criteria:
Cohort 1 Exclusion Criteria:
Cohort 2 Inclusion Criteria:
Cohort 2 Exclusion Criteria: (all Cohort 1 exclusion criteria [#1-8 above] plus the below addition criterion) 9. Previously enrolled in a Seres Therapeutics clinical study. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
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Administrative Information | |||||||||
NCT Number ICMJE | NCT03183141 | ||||||||
Other Study ID Numbers ICMJE | SERES-013 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Seres Therapeutics, Inc. | ||||||||
Study Sponsor ICMJE | Seres Therapeutics, Inc. | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Seres Therapeutics, Inc. | ||||||||
Verification Date | August 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |