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

NCT03183141 | Completed Phase 3 Results FDA Drug

• 1 other identifier: SERES-013
• Study Type: interventional
• Target: 263
• Locations: 2 countries
• Sites: 107

Brief 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.

Conditions

Clostridioides Difficile Infection

Keywords

Clostridioides infection; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Gram-Positive Bacterial Infections; Communicable Diseases

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

SER-109

EXPERIMENTAL

Received oral dose of SER-109

Biological: SER-109

Interventions

SER-109 BIOLOGICAL

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

Also known as: Firmicutes spores

SER-109

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Female subjects who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
• Known or suspected toxic megacolon and/or known small bowel ileus.
• 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.
• Absolute neutrophil count of \<500 cells/mm\^3.
• 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).
• 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.
• 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).
• Any history of fecal microbiota transplantation (FMT) in the past 3 months.
• 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.
• 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.
• \. 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.

Sponsors & Collaborators

• Seres Therapeutics, Inc.: lead

Study Sites (107)

(Investigator site)

Dothan, Alabama, 36305, United States

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Sun City West, Arizona, 85375, United States

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Mather, California, 95655, United States

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Mountain View, California, 94040, United States

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Murrieta, California, 92563, United States

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Northridge, California, 91324, United States

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Sacramento, California, 95817, United States

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San Bernardino, California, 92408, United States

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San Diego, California, 92123, United States

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San Dimas, California, 91773, United States

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Simi Valley, California, 93065, United States

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Thousand Oaks, California, 91360, United States

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Clearwater, Florida, 33756, United States

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Clearwater, Florida, 33761, United States

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DeLand, Florida, 32720, United States

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Hialeah, Florida, 33016, United States

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Homestead, Florida, 33032, United States

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Jacksonville, Florida, 32256, United States

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Miami, Florida, 33125, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33144, United States

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Miami, Florida, 33155, United States

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Miami, Florida, 33165, United States

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Miami, Florida, 33175, United States

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Miami Lakes, Florida, 33014, United States

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Naples, Florida, 34102, United States

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Orlando, Florida, 32819, United States

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Pembroke Pines, Florida, 33024, United States

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Pembroke Pines, Florida, 33026, United States

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Port Orange, Florida, 32127, United States

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Athens, Georgia, 30607, United States

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Atlanta, Georgia, 30322, United States

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Decatur, Georgia, 30033, United States

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Marietta, Georgia, 30060, United States

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Morrow, Georgia, 30260, United States

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Boise, Idaho, 83706, United States

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Idaho Falls, Idaho, 83404, United States

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Chicago, Illinois, 60637, United States

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Oak Lawn, Illinois, 60453, United States

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Springfield, Illinois, 62703, United States

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Evansville, Indiana, 47714, United States

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Iowa City, Iowa, 52242, United States

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Kansas City, Kansas, 66160, United States

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New Orleans, Louisiana, 70121, United States

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Annapolis, Maryland, 21401, United States

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Chevy Chase, Maryland, 20815, United States

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Glen Burnie, Maryland, 21061, United States

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Boston, Massachusetts, 02114, United States

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Framingham, Massachusetts, 01702, United States

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North Dartmouth, Massachusetts, 02747, United States

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Weymouth, Massachusetts, 02190, United States

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Worcester, Massachusetts, 01655, United States

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Chesterfield, Michigan, 48047, United States

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Detroit, Michigan, 48202, United States

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Flint, Michigan, 48504, United States

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Royal Oak, Michigan, 48073, United States

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Wyoming, Michigan, 49519, United States

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Rochester, Minnesota, 55905, United States

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Chesterfield, Missouri, 63017, United States

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Butte, Montana, 59701, United States

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Morristown, New Jersey, 07960, United States

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Neptune City, New Jersey, 07754, United States

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Buffalo, New York, 14215, United States

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New York, New York, 10279, United States

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Charlotte, North Carolina, 28210, United States

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Greenville, North Carolina, 27834, United States

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Jacksonville, North Carolina, 28546, United States

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Kinston, North Carolina, 28501, United States

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Akron, Ohio, 44304, United States

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Centerville, Ohio, 45459, United States

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Cincinnati, Ohio, 45219, United States

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Cleveland, Ohio, 44195, United States

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Mentor, Ohio, 44060, United States

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Toledo, Ohio, 43617, United States

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Camp Hill, Pennsylvania, 17011, United States

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Harrisburg, Pennsylvania, 17110, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Sayre, Pennsylvania, 18840, United States

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Providence, Rhode Island, 02905, United States

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Union City, Tennessee, 38261, United States

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Cypress, Texas, 77429, United States

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Garland, Texas, 75044, United States

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Houston, Texas, 77024, United States

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Houston, Texas, 77025, United States

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Houston, Texas, 77057, United States

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Houston, Texas, 77084, United States

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McKinney, Texas, 75071, United States

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Pasadena, Texas, 77505, United States

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San Antonio, Texas, 78229, United States

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Southlake, Texas, 76092, United States

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Spring, Texas, 77379, United States

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Ogden, Utah, 84403, United States

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Riverton, Utah, 84065, United States

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Salt Lake City, Utah, 84114, United States

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Spokane, Washington, 99202, United States

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Tacoma, Washington, 98405, United States

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Milwaukee, Wisconsin, 53215, United States

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Calgary, Alberta, T2N 2T9, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Victoria, British Columbia, V8R 1J8, Canada

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St. John's, Newfoundland and Labrador, A1B 3V6, Canada

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London, Ontario, N6A 4V2, Canada

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North Bay, Ontario, P1B 2H3, Canada

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Scarborough Village, Ontario, M1P 2T7, Canada

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Chicoutimi, Quebec, G7H 7Y8, Canada

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Québec, Quebec, G2J 0C4, Canada

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(Investigator site)

Sainte-Foy, Quebec, G1W 4R4, Canada

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Related Publications (2)

• Kraft CS, Sims M, Silverman M, Louie TJ, Feuerstadt P, Huang ES, Khanna S, Berenson CS, Wang EEL, Cohen SH, Korman L, Lee C, Kelly CR, Odio A, Cook PP, Lashner B, Ramesh M, Kumar P, De A, Memisoglu A, Lombardi DA, Hasson BR, McGovern BH, von Moltke L, Pardi DS; ECOSPOR III and ECOSPOR IV investigators. Integrated Safety and Efficacy Analyses of Phase 3 Trials of a Microbiome Therapeutic for Recurrent CDI. Infect Dis Ther. 2024 Oct;13(10):2105-2121. doi: 10.1007/s40121-024-01007-z. Epub 2024 Jun 28.

  PMID: 38941068 DERIVED

• Sims MD, Khanna S, Feuerstadt P, Louie TJ, Kelly CR, Huang ES, Hohmann EL, Wang EEL, Oneto C, Cohen SH, Berenson CS, Korman L, Lee C, Lashner B, Kraft CS, Ramesh M, Silverman M, Pardi DS, De A, Memisoglu A, Lombardi DA, Hasson BR, McGovern BH, von Moltke L; ECOSPOR IV Investigators. Safety and Tolerability of SER-109 as an Investigational Microbiome Therapeutic in Adults With Recurrent Clostridioides difficile Infection: A Phase 3, Open-Label, Single-Arm Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2255758. doi: 10.1001/jamanetworkopen.2022.55758.

  PMID: 36780159 DERIVED

MeSH Terms

Conditions

Clostridium Infections; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Gram-Positive Bacterial Infections; Communicable Diseases

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Lisa von Moltke, MD, Chief Medical Officer
• Organization: Seres Therapeutics

clinicalstudies@serestherapeutics.com

617-945-9626

Study Officials

• Elaine Wang, MD

  Seres Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 9, 2017
• Study Start: October 23, 2017
• Primary Completion: April 29, 2022
• Study Completion: April 29, 2022
• Last Updated: April 10, 2023
• Results First Posted: March 31, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10); US (97)