A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection

Study Overview
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Brief Summary
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This trial will be initiated to explore whether RBX2660 (REBYOTA®) could be suitable for administration by the practice of colonoscopy. More specifically, the purpose of this trial is to explore the safety and clinical effectiveness of RBX2660 when delivered by colonoscopy to adults with rCDI. The experience of physicians will be documented through a physician-experience questionnaire to explore the usability of RBX2660 in clinical practice for colonoscopic administration. Furthermore, to explore the patient-experience of RBX2660 treatment, each trial participant will be offered to undergo a structured interview.

Official Title
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A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection

Conditions
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Clostridium Difficile Infection Recurrence

Intervention / Treatment
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* Drug: RBX2660


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have documented evidence of rCDI (≥1 recurrence after a primary CDI episode) be undergoing antibiotic treatment for the qualifying rCDI episode that was diagnosed by a stool test for the presence of toxigenic C. difficile or C. difficile toxin be eligible for FMT as judged by the investigator or current treatment guidelines for rCDI in the US be a candidate for colonoscopy as judged by the investigator Exclusion Criteria: Use or planned use of systemic antibiotics for an indication other than the qualifying rCDI episode. Current uncontrolled chronic diarrhea not related to CDI. Receipt of CDI vaccine or treatment with CDI monoclonal antibodies within the past 12 months before screening. Evidence of active, severe, or fulminant colitis, diagnosis of toxic megacolon or have a current colostomy or ileostomy

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RBX2660<br> | Drug: RBX2660<br>* RBX2660 should be administered to the right side of the colon (i.e., between the ileocecal valve and the hepatic flexure of the colon).<br>* Other names: REBYOTA®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RBX2660-related treatment-emergent adverse events (TEAEs) after RBX2660 treatment delivered by colonoscopy through 8 weeks, or treatment failure |  | 8 weeks after RBX2660 treatment delivered by colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of Clostridioides difficile infection (CDI) within 8 weeks after RBX2660 treatment delivered by colonoscopy. |  | Within 8 weeks after RBX2660 treatment delivered by colonoscopy | 
| Time to CDI recurrence from baseline through 8 weeks after RBX2660 treatment delivered by colonoscopy |  | 8 weeks after RBX2660 treatment delivered by colonoscopy | 
| Physician-experience, as determined by questionnaire, documenting subjective experience of investigators on usability of RBX2660 in clinical practice when delivered by colonoscopy |  | At Day 1 (baseline visit) | 
| Physician perception of patient benefit, as determined by Clinician Global Impression of Improvement (CGI-I) at 8 weeks, or at treatment failure, after RBX2660 treatment delivered by colonoscopy |  | 8 weeks after RBX2660 treatment delivered by colonoscopy | 
| Patient-experience interview at 8 weeks, or at treatment failure, after RBX2660 treatment delivered by colonoscopy |  | 8 weeks after RBX2660 treatment delivered by colonoscopy | 
| TEAEs, including type, intensity, and causality |  | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy | 
| Serious adverse events (SAEs) |  | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy | 
| Adverse events of special interest (AESIs): septic shock, toxic megacolon, colonic perforation, and emergency colectomy |  | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy | 
| Adverse events leading to death or intensive care unit (ICU) admission |  | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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C. Difficile Diarrhea, Clostridium Difficile, CDI, FMT, Fecal Microbiota Transplant, Microbiota Restoration Therapy, Diarrhea, Microbial Suspension, Fecal Transplant, C Difficile Colitis, Clostridium Difficile Associated Diarrhea, C diff diarrhea, C Difficile, C diff