ECOSPOR IV: An Open-Label Extension of Study SERES 012 Evaluating SER-109 in Subjects With Recurrent Clostridium Difficile Infection (ECOSPORIV)

• ClinicalTrials.gov Identifier: NCT03183141
• Recruitment Status: Enrolling by invitation
• First Posted: June 9, 2017
• Last Update Posted: May 6, 2019
• Sponsor: Seres Therapeutics, Inc.
• Information provided by (Responsible Party): Seres Therapeutics, Inc.

Study Description

Brief Summary:

Subjects who had a CDI recurrence in Study SERES-012 within 8 weeks of receipt of study drug will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. The purpose of this study is to assess safety and efficacy of SER-109 in reducing recurrence of Clostridium difficile infection (CDI) in adults who had a CDI recurrence within 8 weeks after receipt of SER-109 or Placebo in Study SERES-012.

Condition or disease	Intervention/treatment	Phase
Clostridium Difficile Infection	Drug: SER-109	Phase 3

Detailed Description:

This 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 in 4 capsules once daily for 3 consecutive days.

Approximately 100 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 45 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ECOSPOR IV: An Open-Label Extension of Study SERES 0012 Evaluating SER-109 in Subjects With Recurrent Clostridium Difficile Infection
• Actual Study Start Date: October 23, 2017
• Estimated Primary Completion Date: February 2020
• Estimated Study Completion Date: April 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: SER-109; SER -109 is an ecology of bacteria in spore form, enriched from stool donations obtained from healthy, screened donors	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

Outcome Measures

Primary Outcome Measures :

1. Recurrence of CDI up to 8 Weeks after treatment [ Time Frame: Up to Week 8 ]
   Recurrence of CD
2. 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

Secondary Outcome Measures :

1. Time to recurrence of CDI [ Time Frame: Up to Week 24 ]
   Time to recurrence of CDI
2. Recurrence of CDI up to 4, 12 and 24 Weeks after treatment [ Time Frame: Up to 4, 12 and 24 Weeks ]
   Recurrence of CDI

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

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)

Contacts and Locations

Locations

United States, Massachusetts

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States, 01655

United States, Montana

Mercury Street Medical

Butte, Montana, United States, 59701

Sponsors and Collaborators

Seres Therapeutics, Inc.

Investigators

• Study Director: Kevin Horgan, MD; Seres Therapeutics, Inc.

More Information

• Responsible Party: Seres Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03183141 History of Changes
• Other Study ID Numbers: SERES-013
• First Posted: June 9, 2017
• Last Update Posted: May 6, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infection; Communicable Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections