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

NCT05831189 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 000416
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 12

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 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 Outcomes (9)

• Number of Participants With 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 Number of Participants With 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

Study Arms (1)

RBX2660

EXPERIMENTAL

Drug: RBX2660

Interventions

RBX2660 DRUG

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

Also known as: REBYOTA®

RBX2660

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (12)

Ferring Investigational Site

North Little Rock, Arkansas, 72117, United States

Location

Ferring Investigational Site

Camarillo, California, 93012, United States

Location

Ferring Investigational Site

Hamden, Connecticut, 06518, United States

Location

Ferring Investigational Site

Idaho Falls, Idaho, 83404, United States

Location

Ferring Investigational Site

Gurnee, Illinois, 60031, United States

Location

Ferring Investigational Site

Shreveport, Louisiana, 71105, United States

Location

Ferring Investigational Site

Plymouth, Minnesota, 55446, United States

Location

Ferring Investigational Site

Rochester, Minnesota, 55905, United States

Location

Ferring Investigational Site

Cleveland, Ohio, 44195, United States

Location

Ferring Investigational Site

Oklahoma City, Oklahoma, 73102, United States

Location

Ferring Investigational Site

Burke, Virginia, 22015, United States

Location

Ferring Investigational Site

Madison, Wisconsin, 53705, United States

Location

Related Publications (4)

• Khanna S, Yoho D, Van Handel D, Clark BJ, Awad T, Guthmueller B, Armandi D, Knapple W, Safdar N, Baggott B, Simon K, Feuerstadt P. Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA(R)) administered by colonoscopy for prevention of recurrent Clostridioides difficile infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial. Ther Adv Gastroenterol. 2025 Apr 22;18:17562848251339697. doi: 10.1177/17562848251339697. eCollection 2025.

  PMID: 40321366 RESULT

• Khanna S, Yoho D, Van Handel D, Clark BJ, Awad T, Guthmueller B, Armandi D, Knapple W, Safdar N, Baggott B, Simon K, Feuerstadt P. Prevention of recurrent Clostridioides difficile infection by fecal microbiota, live-jslm (REBYOTA(R)) administered via colonoscopy: 6-month data from the single-arm phase IIIb CDI-SCOPE trial. Ther Adv Gastroenterol. 2025 Nov 9;18:17562848251396744. doi: 10.1177/17562848251396744. eCollection 2025.

  PMID: 41230019 RESULT

• McCool-Myers M, Umanzor-Figueroa C, Symonds T, Landeira M, Awad T, Armandi D, Guthmueller B & Khanna S. Patient-reported benefits of colonoscopically administered microbiota restoration therapy: a qualitative study of adult patients with recurrent Clostridioides difficile infection. Therapeutic Advances in Gastroenterology. 2025 Nov 14; 18:17562848251392102. doi: 10.1177/17562848251392102.

  RESULT

• McCool-Myers M, Umanzor-Figueroa C, Symonds T, Landeira M, Awad T, Armandi D, Guthmueller B, Khanna S. Patient-reported benefits of colonoscopicallyadministered microbiota restoration therapy: a qualitative study of adult patients with recurrent Clostridioides difficile infection. Ther Adv Gastroenterol. 2025 Nov 14;18:17562848251392102. doi: 10.1177/17562848251392102. eCollection 2025.

  PMID: 41647268 DERIVED

Related Links

• Safety and effectiveness of fecal microbiota, live-jslm (REBYOTA(R)) administered by colonoscopy for prevention of recurrent Clostridioides difficile infection: 8-week results from CDI-SCOPE, a single-arm, phase IIIb trial
• Prevention of recurrent Clostridioides difficile infection by fecal microbiota, live-jslm (REBYOTA(R)) administered via colonoscopy: 6-month data from the single-arm phase IIIb CDI-SCOPE trial.

MeSH Terms

Conditions

Diarrhea; Enterocolitis, Pseudomembranous

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Global Clinical Compliance
• Organization: Ferring Pharmaceuticals A/S

disclosure@ferring.com

1-888-3377464

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: April 21, 2023
• Primary Completion: January 17, 2025
• Study Completion: January 17, 2025
• Last Updated: April 24, 2026
• Results First Posted: April 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)