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

April 7, 2026 updated by: Ferring Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Ferring Investigational Site
    • California
      • Camarillo, California, United States, 93012
        • Ferring Investigational Site
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Ferring Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Ferring Investigational Site
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Ferring Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Ferring Investigational Site
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Ferring Investigational Site
      • Rochester, Minnesota, United States, 55905
        • Ferring Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Ferring Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Ferring Investigational Site
    • Virginia
      • Burke, Virginia, United States, 22015
        • Ferring Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Ferring Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With RBX2660-related Treatment-emergent Adverse Events (TEAEs) After RBX2660 Treatment Delivered by Colonoscopy Through 8 Weeks, or Treatment Failure
Time Frame: 8 weeks after RBX2660 treatment delivered by colonoscopy
8 weeks after RBX2660 treatment delivered by colonoscopy

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Recurrence of Clostridioides Difficile Infection (CDI) Within 8 Weeks After RBX2660 Treatment Delivered by Colonoscopy.
Time Frame: 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
Time Frame: 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
Time Frame: At Day 1 (baseline visit)
At Day 1 (baseline visit)
Physician Perception of Patient Benefit, as Determined by Number of Participants With Clinician Global Impression of Improvement (CGI-I) at 8 Weeks, or at Treatment Failure, After RBX2660 Treatment Delivered by Colonoscopy
Time Frame: 8 weeks 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
Time Frame: 8 weeks after RBX2660 treatment delivered by colonoscopy
8 weeks after RBX2660 treatment delivered by colonoscopy
Number of Participants With Treatment-emergent Adverse Events up to 8 Weeks or Treatment Failure After RBX2660 Treatment
Time Frame: Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
Number of Participants With Any Adverse Events of Special Interest (AESIs)
Time Frame: Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
Number of Participants With Adverse Events Leading to Death or Intensive Care Unit (ICU) Admission
Time Frame: Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
Up to 8 weeks after RBX2660 treatment delivered by colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Investigators

  • Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2023

Primary Completion (Actual)

January 17, 2025

Study Completion (Actual)

January 17, 2025

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000416

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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