ECOSPOR IV: Open-Label Study of SER-109 in Adults With Recurrent Clostridium Difficile Infection

Last updated: July 8, 2016
Sponsor: Seres Therapeutics, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Clostridium Difficile-associated Diarrhea

Gastroenteritis

Treatment

N/A

Clinical Study ID

NCT02830581
SERES-008
  • Ages > 18
  • Both

Study Summary

A one time single dose of experimental drug (SER-109) will be administered in this study. The purpose of this study is to determine whether SER-109 is effective in preventing Clostridium difficile infection (CDI) recurrence in adults who had a CDI recurrence within 8 weeks after receipt of SER-109 or Placebo in Study SERES-007.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Previously enrolled in Study SERES-007 and had CDI recurrence within 8 weeks afterreceipt of study drug.

  2. Signed informed consent prior to initiation of any study-specific procedure ortreatment. The subject must be able to provide written informed consent andunderstand the potential risks and benefits from study enrollment and treatment.

  3. The CDI recurrence in Study SERES-007 must have met the protocol definition of ≥ 3unformed stools per day over 2 consecutive days, a positive C. difficile stool test,and assessment by the investigator that the clinical condition of the subjectwarranted treatment.

Exclusion

Exclusion Criteria:

  1. Female subjects who are pregnant, breastfeeding, lactating, or planning to becomepregnant during the study.

  2. Known or suspected toxic megacolon and/or known small bowel ileus.

  3. Active irritable bowel syndrome with diarrhea within the previous 12 months.

  4. Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding).

  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.

  6. History of active inflammatory bowel disease (ulcerative colitis, Crohn's disease,microscopic colitis) with diarrhea believed to be caused by active inflammatory boweldisease in the past 12 months.

  7. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment foractive malignancy (subjects on maintenance chemotherapy may only be enrolled afterconsultation with the study medical monitor).

Study Design

Total Participants: 87
Study Start date:
October 01, 2016
Estimated Completion Date:
November 30, 2017

Study Description

This is an open-label extension of Study SERES-007. A single dose (1 × 10^8 spore equivalents [SporQs]) of SER-109 in 4 capsules will be administered to subjects who had a recurrence of CDI within 8 weeks of receipt of study drug in Study SERES-007 and have responded to a course of standard of care (SOC) antibiotic treatment (14 days of oral vancomycin,10 days of oral fidaxomicin, or 10 to 14 days of oral metronidazole). Approximately 87 eligible subjects with recurrent CDI disease from Study SERES-007 are expected to enroll. Screening for this study will begin at the Early Termination Visit of Study SERES-007.