RBX2660 for C. Diff Infection

(CDI-SCOPE Trial)

Recruiting at 13 trial locations

Overseen By Global Clinical Compliance

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ferring Pharmaceuticals

Must be taking: Antibiotics

Must not be taking: Systemic antibiotics

Disqualifiers: Chronic diarrhea, Severe colitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

41 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Global Clinical Compliance

Principal Investigator

Ferring Pharmaceuticals

Eligibility Criteria

This trial is for adults with recurrent Clostridioides difficile infection (rCDI), who have had at least one recurrence after the initial episode. Participants must be currently treated with antibiotics for rCDI, confirmed by a stool test, and eligible for fecal microbiota transplantation (FMT) as per US guidelines.

Inclusion Criteria

Have documented evidence of rCDI (≥1 recurrence after a primary CDI episode)

I am considered eligible for a fecal transplant to treat my recurrent C. diff infection.

Be a candidate for colonoscopy as judged by the investigator

Exclusion Criteria

I do not have severe bowel inflammation or a current colostomy or ileostomy.

I have ongoing severe diarrhea not caused by an infection.

I am using or will use antibiotics for a reason other than my current infection.

Treatment Details

Interventions

• RBX2660

Trial Overview The trial tests RBX2660 (REBYOTA®) administered via colonoscopy to assess its safety and effectiveness in treating rCDI. It includes documenting physician experiences through a questionnaire and interviewing patients to understand their treatment experience.

Participant Groups

Group I: RBX2660 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Ferring Pharmaceuticals

Lead Sponsor

Trials

323

Recruited

1,242,000+

Pierre-Yves Berclaz

Ferring Pharmaceuticals

Chief Medical Officer since 2023

MD from the University of Lausanne, PhD in Molecular Biology from the Cincinnati College of Medicine

Jean-Frédéric Paulsen

Ferring Pharmaceuticals

Chief Executive Officer since 2023

Master’s degree in Finance from the London School of Economics and Political Science