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

Phase 3

Completed

• Conditions: Clostridium Difficile Infection Recurrence
• Interventions: Drug: RBX2660

• Registration Number: NCT05831189
• Lead Sponsor: Ferring Pharmaceuticals

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 participant will be offered to undergo a structured interview.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-04-14
• Study Start: 2023-04-21
• Study First Posted: 2023-04-26
• Status Verified: 2025-01
• Primary Completion: 2025-01-17
• Study Completion: 2025-01-17
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RBX2660	RBX2660	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Time to CDI recurrence from baseline through 8 weeks 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
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
Recurrence of Clostridioides difficile infection (CDI) within 8 weeks after RBX2660 treatment delivered by colonoscopy.	Within 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)
Adverse events leading to death or intensive care unit (ICU) admission	Up to 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
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

Trial Locations

Locations (1)

Ferring Investigational Site; 🇺🇸 Madison, Wisconsin, United States