SER-262 Versus Placebo in Adults With Primary Clostridium Difficile Infection to Prevent Recurrence

Phase 1

Completed

• Conditions: Clostridium Difficile Infection
• Interventions: Drug: SER-262; Drug: Placebo

• Registration Number: NCT02830542
• Lead Sponsor: Seres Therapeutics, Inc.

Brief Summary

The study will involve administering a single dose of investigational drug or placebo in ascending dose cohorts. This study is designed to evaluate the safety and tolerability of investigational drug as well as the efficacy of investigational drug versus placebo in adults with primary (first episode) Clostridium difficile infection (CDI).

Detailed Description

SER-262-001 is a Phase 1b, randomized, double blind, placebo-controlled, ascending single dose clinical study with 2 treatment arms (SER-262 or placebo) in up to 8 dose cohorts. Patients who have been diagnosed with their first (primary) episode of CDI, defined as diarrhea (≥ 3 unformed stools per day for 2 consecutive days), a positive C. difficile stool test and who have responded to standard-of-care antibiotic will receive investigational drug or placebo on Day 1.

Study Timeline

• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-13
• Study Start: 2016-08
• Primary Completion: 2018-05
• Study Completion: 2018-08
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. Signed informed consent, indicating that the subject understands the purpose of and procedures required for the study.
2. Male or female subjects ≥ 18 years.
3. A primary (first) episode of CDI with documentation of the episode including CDI date, test results, antibiotic treatment (including start and stop dates), and response to treatment

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Exclusion Criteria

1. Females 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. Active irritable bowel syndrome with diarrhea within the previous 12 months.
4. Major gastrointestinal surgery (eg, 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.
5. History of inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 12 months.
6. Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2
7. Admitted to or expected to be admitted to an intensive care unit for medical reasons (not just boarding). Patients discharged from an intensive care unit before Day 1 may be enrolled.
8. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor).
9. Absolute neutrophil count < 500 cells/mm3

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SER-262	SER-262	SER-262 \[Single dose: 10(4), 10(5), 10(6), 10(7) or 10(8) SCFUs; Multiple dose 10(6), 10(7), or 10(8) SCFUs\]
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of SER-262 as assessed by incidence of AEs, lab results, vital signs, ECG, and physical examination findings	Up to 24 weeks after treatment
Relative risk of recurrence based on the proportion of subjects experiencing CDI recurrence in each SER-262 cohort compared to placebo up to 8 weeks after treatment	Up to 8 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
Time to recurrence of CDI	Up to 24 weeks after treatment
Relative risk of recurrence of CDI up to 4, 12, and 24 weeks after treatment	Up to 4, 12, and 24 weeks after treatment

Trial Locations

Locations (22)

Remington Davis; 🇺🇸 Columbus, Ohio, United States

North Alabama Research Center, LLC; 🇺🇸 Athens, Alabama, United States

Lalla-Reddy Medical Corporation; 🇺🇸 Fountain Valley, California, United States

eStudySite; 🇺🇸 La Mesa, California, United States

San Marcus Research Clinic, Inc.; 🇺🇸 Miami, Florida, United States

Omega Research Consultants; 🇺🇸 Orlando, Florida, United States

Snake River Research; 🇺🇸 Idaho Falls, Idaho, United States

Clinical Research Atlanta; 🇺🇸 Stockbridge, Georgia, United States

Anne Arundel Health System Research Institute; 🇺🇸 Annapolis, Maryland, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Sundance Clinical Research, LLC; 🇺🇸 Saint Louis, Missouri, United States

Mercury St. Medical Group; 🇺🇸 Butte, Montana, United States

Quality Clinical Research; 🇺🇸 Omaha, Nebraska, United States

Regional Infectious Diseases & Infusion Center; 🇺🇸 Lima, Ohio, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Dr. Hansen Internal Medicine; 🇺🇸 Bountiful, Utah, United States

Baylor Scott & White Research Institute; 🇺🇸 Temple, Texas, United States

Infectious Disease Associates of Central Virginia; 🇺🇸 Lynchburg, Virginia, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Jersey Shore University Medical Center; 🇺🇸 Neptune, New Jersey, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States