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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy of SER-262 in Adults With Primary Clostridium Difficile Infection (CDI) to Prevent Recurrence

Conditions
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Clostridium Difficile Infection

Intervention / Treatment
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* Drug: SER-262
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent, indicating that the subject understands the purpose of and procedures required for the study. Male or female subjects ≥ 18 years. 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 Exclusion Criteria: Females who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study. Known or suspected toxic megacolon and/or known small bowel ileus. Active irritable bowel syndrome with diarrhea within the previous 12 months. 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. 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. Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2 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. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor). Absolute neutrophil count < 500 cells/mm3

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SER-262<br>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] | Drug: SER-262<br>* SER-262 is a rationally designed, multi-strain Ecobiotic® microbiome therapeutic produced synthetically by in vitro fermentation. It is a consortium of anaerobic, commensal bacteria in spore form, encapsulated for oral administration.<br>* Other names: Cultivated Eubacterial Spore Suspension, Encapsulated;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo will be identical to the investigational product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clostridium difficile, C Diff, CDI