ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection

Clostridioides Difficile Infection Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03183141
• Other study ID #: SERES-013
• Status: Completed
• Phase: Phase 3
• Start date: October 23, 2017
• Est. completion date: April 29, 2022

Study information

• Verified date: April 2023
• Source: Seres Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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, 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 polymerase chain reaction (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: April 29, 2022
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Cohort 1 Main Inclusion Criteria:

1. Previously enrolled in Study SERES-012, had CDI recurrence within 8 weeks after receipt of a treatment regimen of SER-109 or placebo

2. Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject, or their legally authorized representative, 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 toxin assay, and the requirement of CDI SOC antibiotic therapy, and an adequate clinical response following antibiotic therapy (<3 unformed stools in 24 hours for 2 or more consecutive days).

Cohort 1 Main 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/mm^3.

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) in the past 3 months.

Cohort 2 Main 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 or PCR test) and have responded to a course of antibiotic treatment.

2. Signed informed consent prior to initiation of any study-specific procedure or treatment. The subject, or their legally authorized representative, must be able to provide written informed consent and understand the potential risks and benefits from study enrollment and treatment.

Cohort 2 Main Exclusion Criteria:

(all Cohort 1 exclusion criteria [#1-8 above] plus the below addition criterion)

9. Previously enrolled in a Seres Therapeutics clinical study. An exception is made for subjects who screened in SERES-012 who did not receive SER-109 and did not previously roll-over to SERES-013.

Related Conditions & MeSH terms

• Clostridioides Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Infections

Intervention

Biological:
• SER-109
SER-109, an oral, biologically derived, live microbiome therapeutic that comprises purified bacterial spores

Locations

Country	Name	City	State
Canada	(Investigator site)	Calgary	Alberta
Canada	(Investigator site)	Chicoutimi	Quebec
Canada	(Investigator site)	London	Ontario
Canada	(Investigator site)	North Bay	Ontario
Canada	(Investigator site)	Québec	Quebec
Canada	(Investigator site)	Saint John's	Newfoundland and Labrador
Canada	(Investigator site)	Sainte-Foy	Quebec
Canada	(Investigator site)	Scarborough	Ontario
Canada	(Investigator site)	Vancouver	British Columbia
Canada	(Investigator site)	Victoria	British Columbia
United States	(Investigator site)	Akron	Ohio
United States	(Investigator site)	Annapolis	Maryland
United States	(Investigator site)	Athens	Georgia
United States	(Investigator site)	Atlanta	Georgia
United States	(Investigator site)	Boise	Idaho
United States	(Investigator site)	Boston	Massachusetts
United States	(Investigator site)	Buffalo	New York
United States	(Investigator site)	Butte	Montana
United States	(Investigator site)	Camp Hill	Pennsylvania
United States	(Investigator site)	Centerville	Ohio
United States	(Investigator site)	Charlotte	North Carolina
United States	(Investigator site)	Chesterfield	Missouri
United States	(Investigator site)	Chesterfield	Michigan
United States	(Investigator site)	Chevy Chase	Maryland
United States	(Investigator site)	Chicago	Illinois
United States	(Investigator site)	Cincinnati	Ohio
United States	(Investigator site)	Clearwater	Florida
United States	(Investigator site)	Clearwater	Florida
United States	(Investigator site)	Cleveland	Ohio
United States	(Investigator site)	Cypress	Texas
United States	(Investigator site)	Decatur	Georgia
United States	(Investigator site)	DeLand	Florida
United States	(Investigator site)	Detroit	Michigan
United States	(Investigator site)	Dothan	Alabama
United States	(Investigator site)	Evansville	Indiana
United States	(Investigator site)	Flint	Michigan
United States	(Investigator site)	Framingham	Massachusetts
United States	(Investigator site)	Garland	Texas
United States	(Investigator site)	Glen Burnie	Maryland
United States	(Investigator site)	Greenville	North Carolina
United States	(Investigator site)	Harrisburg	Pennsylvania
United States	(Investigator site)	Hialeah	Florida
United States	(Investigator site)	Homestead	Florida
United States	(Investigator site)	Houston	Texas
United States	(Investigator site)	Houston	Texas
United States	(Investigator site)	Houston	Texas
United States	(Investigator site)	Houston	Texas
United States	(Investigator site)	Idaho Falls	Idaho
United States	(Investigator site)	Iowa City	Iowa
United States	(Investigator site)	Jacksonville	Florida
United States	(Investigator site)	Jacksonville	North Carolina
United States	(Investigator site)	Kansas City	Kansas
United States	(Investigator site)	Kinston	North Carolina
United States	(Investigator site)	Marietta	Georgia
United States	(Investigator site)	Mather	California
United States	(Investigator site)	McKinney	Texas
United States	(Investigator site)	Mentor	Ohio
United States	(Investigator site)	Miami	Florida
United States	(Investigator site)	Miami	Florida
United States	(Investigator site)	Miami	Florida
United States	(Investigator site)	Miami	Florida
United States	(Investigator site)	Miami	Florida
United States	(Investigator site)	Miami	Florida
United States	(Investigator site)	Miami Lakes	Florida
United States	(Investigator site)	Milwaukee	Wisconsin
United States	(Investigator site)	Morristown	New Jersey
United States	(Investigator site)	Morrow	Georgia
United States	(Investigator site)	Mountain View	California
United States	(Investigator site)	Murrieta	California
United States	(Investigator site)	Naples	Florida
United States	(Investigator site)	Neptune	New Jersey
United States	(Investigator site)	New Orleans	Louisiana
United States	(Investigator site)	New York	New York
United States	(Investigator site)	North Dartmouth	Massachusetts
United States	(Investigator site)	Northridge	California
United States	(Investigator site)	Oak Lawn	Illinois
United States	(Investigator site)	Ogden	Utah
United States	(Investigator site)	Orlando	Florida
United States	(Investigator site)	Pasadena	Texas
United States	(Investigator site)	Pembroke Pines	Florida
United States	(Investigator site)	Pembroke Pines	Florida
United States	(Investigator site)	Pittsburgh	Pennsylvania
United States	(Investigator site)	Port Orange	Florida
United States	(Investigator site)	Providence	Rhode Island
United States	(Investigator site)	Riverton	Utah
United States	(Investigator site)	Rochester	Minnesota
United States	(Investigator site)	Royal Oak	Michigan
United States	(Investigator site)	Sacramento	California
United States	(Investigator site)	Salt Lake City	Utah
United States	(Investigator site)	San Antonio	Texas
United States	(Investigator site)	San Bernardino	California
United States	(Investigator site)	San Diego	California
United States	(Investigator site)	San Dimas	California
United States	(Investigator site)	Sayre	Pennsylvania
United States	(Investigator site)	Simi Valley	California
United States	(Investigator site)	Southlake	Texas
United States	(Investigator site)	Spokane	Washington
United States	(Investigator site)	Spring	Texas
United States	(Investigator site)	Springfield	Illinois
United States	(Investigator site)	Sun City West	Arizona
United States	(Investigator site)	Tacoma	Washington
United States	(Investigator site)	Thousand Oaks	California
United States	(Investigator site)	Toledo	Ohio
United States	(Investigator site)	Union City	Tennessee
United States	(Investigator site)	Weymouth	Massachusetts
United States	(Investigator site)	Worcester	Massachusetts
United States	(Investigator site)	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Seres Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort 1: Recurrence of CDI and Sustained Clinical Response	Cohort 1: Recurrence of CDI up to 8 Weeks after treatment. Recurrence was determined by stool Clostridioides difficile toxin assay. Sustained clinical response was the absence of CDI recurrence up to 8 Weeks after treatment.	Up to Week 8
Primary	Cohort 2: Recurrence of CDI and Sustained Clinical Response	Cohort 2: Recurrence of CDI up to 8 and 12 Weeks after treatment. Recurrence was determined by stool Clostridioides difficile toxin assay. Sustained clinical response was the absence of CDI recurrence up to 8 and 12 Weeks after treatment.	Up to Weeks 8 and 12