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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
Sponsor:
Information provided by (Responsible Party):
Seres Therapeutics, Inc.

Tracking Information
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
 (submitted: August 19, 2020)
  • Cohort 1: Recurrence of CDI up to 8 Weeks after treatment [ Time Frame: Up to Week 8 ]
    Recurrence of CDI
  • Cohort 1: Safety and tolerability of SER-109 assessed by incidence of AEs, lab results, vital signs, ECG, and physical examination findings [ Time Frame: Up to Week 24 ]
    Safety & Tolerability
  • Cohort 2: Recurrence of CDI and sustained clinical response up to 8 and 12 weeks after treatment [ Time Frame: Up to Weeks 8 and 12 ]
    Recurrence of CDI and sustained clinical response
  • Cohort 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
  • Recurrence of CDI up to 8 Weeks after treatment [ Time Frame: Up to Week 8 ]
    Recurrence of CD
  • Safety and tolerability of SER-109 assessed by incidence of AEs, lab results, vital signs, ECG, and physical examination findings [ Time Frame: Up to Week 24 ]
    Safety & Tolerability
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2020)
  • Cohort 1: Time to recurrence of CDI [ Time Frame: Up to Week 24 ]
    Time to recurrence of CDI
  • Cohort 1: Recurrence of CDI up to 4, 12 and 24 Weeks after treatment [ Time Frame: Up to 4, 12 and 24 Weeks ]
    Recurrence of CDI
Original Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
  • Time to recurrence of CDI [ Time Frame: Up to Week 24 ]
    Time to recurrence of CDI
  • Recurrence of CDI up to 4, 12 and 24 Weeks after treatment [ Time Frame: Up to 4, 12 and 24 Weeks ]
    Recurrence of CDI
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.
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.
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
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
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
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: August 19, 2020)		 225
Original Estimated Enrollment  ICMJE
 (submitted: June 8, 2017)		 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:

  1. Previously enrolled in Study SERES-012, had CDI recurrence within 8 weeks after receipt of study drug, and have completed their SERES-012 Week 8 visit.
  2. Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject must be able to provide written informed consent and understand the potential risks and benefits from study enrollment and treatment.
  3. The CDI recurrence in Study SERES-012 must have met the protocol definition of ≥ 3 unformed stools per day over 2 consecutive days, a positive C. difficile stool test, and assessment by the investigator that the clinical condition of the subject warranted treatment.

Cohort 1 Exclusion Criteria:

  1. Female subjects who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
  2. Known or suspected toxic megacolon and/or known small bowel ileus.
  3. Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). Note: nursing homes, rehabilitation, assisted living centers and acute care hospitals are acceptable.
  4. Absolute neutrophil count of <500 cells/ml3.
  5. Major gastrointestinal surgery (e.g. significant bowel resection or diversion) within 3 months before enrollment (this does not include appendectomy or cholecystectomy), or any history of total colectomy or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e., restrictive procedures such as banding, are permitted).
  6. History of active inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 3 months.
  7. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (subjects on maintenance chemotherapy may only be enrolled after consultation with the study medical monitor).
  8. Any history of fecal microbiota transplantation (FMT).

Cohort 2 Inclusion Criteria:

  1. Subjects 18 years of age or older who had one or more CDI recurrence (as confirmed by a C. difficile stool toxin test) within 12 months and have responded to a course of standard of care antibiotic treatment.
  2. Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject must be able to provide written informed consent and understand the potential risks and benefits from study enrollment and treatment.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elaine Wang, MD 617-945-9626 ewang@serestherapeutics.com
Contact: Lisa von Moltke, MD 617-945-9626 lvonmoltke@serestherapeutics.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03183141
Other Study ID Numbers  ICMJE SERES-013
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
Plan to Share IPD: No
Responsible Party Seres Therapeutics, Inc.
Study Sponsor  ICMJE Seres Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Elaine Wang, MD Seres Therapeutics, Inc.
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