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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 (CDI-SCOPE)

Primary Purpose

Clostridium Difficile Infection Recurrence

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
RBX2660
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection Recurrence focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting
  • Ferring Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RBX2660

Arm Description

Outcomes

Primary Outcome Measures

RBX2660-related treatment-emergent adverse events (TEAEs) after RBX2660 treatment delivered by colonoscopy through 8 weeks, or treatment failure

Secondary Outcome Measures

Recurrence of Clostridioides difficile infection (CDI) within 8 weeks after RBX2660 treatment delivered by colonoscopy.
Time to CDI recurrence from baseline through 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
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
Patient-experience interview at 8 weeks, or at treatment failure, after RBX2660 treatment delivered by colonoscopy
TEAEs, including type, intensity, and causality
Serious adverse events (SAEs)
Adverse events of special interest (AESIs): septic shock, toxic megacolon, colonic perforation, and emergency colectomy
Adverse events leading to death or intensive care unit (ICU) admission

Full Information

First Posted
April 14, 2023
Last Updated
October 23, 2023
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05831189
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2023 (Actual)
Primary Completion Date
June 14, 2024 (Anticipated)
Study Completion Date
October 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 participant will be offered to undergo a structured interview.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection Recurrence
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RBX2660
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RBX2660
Other Intervention Name(s)
REBYOTA®
Intervention Description
RBX2660 should be administered to the right side of the colon (i.e., between the ileocecal valve and the hepatic flexure of the colon).
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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)
Title
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
Time Frame
8 weeks after RBX2660 treatment delivered by colonoscopy
Title
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
Title
TEAEs, including type, intensity, and causality
Time Frame
Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
Title
Serious adverse events (SAEs)
Time Frame
Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
Title
Adverse events of special interest (AESIs): septic shock, toxic megacolon, colonic perforation, and emergency colectomy
Time Frame
Up to 8 weeks after RBX2660 treatment delivered by colonoscopy
Title
Adverse events leading to death or intensive care unit (ICU) admission
Time Frame
Up to 8 weeks after RBX2660 treatment delivered by colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Global Clinical Compliance
Phone
+1 833-548-1402 (US/Canada)
Email
DK0-Disclosure@ferring.com
First Name & Middle Initial & Last Name or Official Title & Degree
Global Clinical Compliance
Phone
+1 862-286-5200 (outside US)
Email
DK0-Disclosure@ferring.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Compliance
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Ferring Investigational Site
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Camarillo
State/Province
California
ZIP/Postal Code
93012
Country
United States
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Individual Site Status
Recruiting
Facility Name
Ferring Investigational Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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