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

Sponsor

Ferring Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05831189

Collaborator

(none)

Enrollment

Locations

Arm

13.1

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 subject will be offered to undergo a structured interview.

Condition or Disease	Intervention/Treatment	Phase
Clostridium Difficile Infection Recurrence	Drug: RBX2660	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 21, 2023

Anticipated Primary Completion Date :

Jan 23, 2024

Anticipated Study Completion Date :

May 23, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RBX2660	Drug: RBX2660 RBX2660 should be administered to the right side of the colon (i.e., between the ileocecal valve and the hepatic flexure of the colon). Other Names: REBYOTA®

Arm

Intervention/Treatment

Experimental: RBX2660

Drug: RBX2660

RBX2660 should be administered to the right side of the colon (i.e., between the ileocecal valve and the hepatic flexure of the colon).

Other Names:

REBYOTA®

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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