Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Butte, Montana and other locations
Dates
study started
estimated completion

Description

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.

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)

Details

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.

Keywords

Clostridioides Difficile Infection Infection Communicable Diseases Clostridium Infections SER-109

Eligibility

For people ages 18 years and up

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.

Locations

  • Mercury Street Medical accepting new patients
    Butte Montana 59701 United States
  • University of Massachusetts Memorial Medical Center accepting new patients
    Worcester Massachusetts 01655 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Seres Therapeutics, Inc.
Links
Sign up for this study
ID
NCT03183141
Phase
Phase 3
Study Type
Interventional
Last Updated