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

Clostridium Difficile Infection Recurrence Clinical Trial

— CDI-SCOPE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05831189
• Other study ID #: 000416
• Status: Recruiting
• Phase: Phase 3
• Start date: April 21, 2023
• Est. completion date: January 16, 2025

Study information

• Verified date: April 2024
• Source: Ferring Pharmaceuticals
• Contact: Global Clinical Compliance
• Phone: +1 833-548-1402 (US/Canada)
• Email: DK0-Disclosure[@]ferring.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 16, 2025
• Est. primary completion date: January 16, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Infection Recurrence
• Clostridium Infections
• Communicable Diseases
• Infections
• Recurrence

Intervention

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).

Locations

Country	Name	City	State
United States	Ferring Investigational Site	Burke	Virginia
United States	Ferring Investigational Site	Camarillo	California
United States	Ferring Investigational Site	Cleveland	Ohio
United States	Ferring Investigational Site	Glenview	Illinois
United States	Ferring Investigational Site	Gurnee	Illinois
United States	Ferring Investigational Site	Hamden	Connecticut
United States	Ferring Investigational Site	Idaho Falls	Idaho
United States	Ferring Investigational Site	Madison	Wisconsin
United States	Ferring Investigational Site	North Little Rock	Arkansas
United States	Ferring Investigational Site	Oklahoma City	Oklahoma
United States	Ferring Investigational Site	Plymouth	Minnesota
United States	Ferring Investigational Site	Rochester	Minnesota
United States	Ferring Investigational Site	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recurrence of Clostridioides difficile infection (CDI) within 8 weeks after RBX2660 treatment delivered by colonoscopy.		Within 8 weeks after RBX2660 treatment delivered by colonoscopy
Secondary	Time to CDI recurrence from baseline through 8 weeks after RBX2660 treatment delivered by colonoscopy		8 weeks after RBX2660 treatment delivered by colonoscopy
Secondary	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)
Secondary	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
Secondary	Patient-experience interview at 8 weeks, or at treatment failure, after RBX2660 treatment delivered by colonoscopy		8 weeks after RBX2660 treatment delivered by colonoscopy
Secondary	TEAEs, including type, intensity, and causality		Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
Secondary	Serious adverse events (SAEs)		Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
Secondary	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
Secondary	Adverse events leading to death or intensive care unit (ICU) admission		Up to 8 weeks after RBX2660 treatment delivered by colonoscopy