ECOSPOR IV: Open-Label Study, Including Study SERES-012 Extension, Evaluating SER-109 in Recurrent Clostridioides Difficile Infection
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|ClinicalTrials.gov Identifier: NCT03183141|
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : October 6, 2021
Cohort 1: Subjects who had a Clostridioides difficile infection (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 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.
|Condition or disease||Intervention/treatment||Phase|
|Clostridioides Difficile Infection||Biological: SER-109||Phase 3|
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, 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 Recurrence 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 and have responded to a course of antibiotic treatment will receive an oral dose of SER-109. The CDI recurrence must be confirmed by a positive C. difficile stool toxin or PCR assay to confirm eligibility. A treatment regimen of SER-109 is defined as an oral dose of SER-109 (4 capsules once daily) for 3 consecutive days.
Approximately 200 eligible subjects with recurrent CDI disease are expected to enroll.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||230 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||October 23, 2017|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||April 2022|
Received oral dose of SER-109
SER-109, an oral, biologically derived, live microbiome therapeutic that comprises purified bacterial spores
Other Name: Firmicutes spores
- Cohort 1 and 2: Safety and tolerability of SER-109 assessed by incidence of AEs, lab results, vital signs, and physical examination findings [ Time Frame: Up to Week 24 ]Safety & Tolerability
- Cohort 1: Recurrence of CDI or sustained clinical response up to 8 Weeks after treatment [ Time Frame: Up to Week 8 ]Recurrence of CDI
- Cohort 2: Recurrence of CDI as determined by a stool toxin assay and sustained clinical response up to 8 and 12 weeks after treatment [ Time Frame: Up to Weeks 8 and 12 ]Recurrence of CDI as determined by a stool toxin assay and sustained clinical response
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): NCT03183141
|Contact: Elaine Wang, MDfirstname.lastname@example.org|
|Contact: Lisa von Moltke, MDemail@example.com|
|Study Director:||Elaine Wang, MD||Seres Therapeutics, Inc.|