RBX2660 for C. Diff Infection

(CDI-SCOPE Trial)

No longer 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: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called RBX2660 to determine its safety and effectiveness when administered through a colonoscopy for individuals with recurring C. diff infections (rCDI), a bacterial infection causing severe diarrhea. Researchers aim to assess the treatment's efficacy and ease of use for doctors. Individuals with at least one recurring C. diff infection who are currently taking antibiotics may be suitable candidates for this trial. As a Phase 3 trial, this treatment represents the final step before FDA approval, providing an opportunity to contribute to a potentially groundbreaking therapy.

Will I have to stop taking my current medications?

The trial requires that you continue taking antibiotics for your current C. diff infection, but you cannot use other systemic antibiotics for different conditions. The protocol does not specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that RBX2660 is likely to be safe for humans?

Research has shown that RBX2660 is safe for people. Studies have found it reduces the recurrence of C. difficile infections after antibiotic treatment. The treatment is generally well-tolerated and has a good safety record. One study found RBX2660 significantly more effective than a placebo in reducing repeat infections, resulting in fewer returning infections for those who took RBX2660.

Most patients experienced only mild side effects, such as stomach discomfort, and serious side effects were rare. These findings suggest RBX2660 is a safe option for those dealing with recurring C. difficile infections. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for C. Diff infection?

RBX2660 is unique because it uses a microbiota-based approach to treat recurrent C. diff infections. Unlike standard treatments like antibiotics, which aim to kill the bacteria, RBX2660 works by restoring the natural balance of good bacteria in the gut. This innovative approach not only targets the root cause of the infection but also reduces the likelihood of recurrence, which is a major issue with current treatments. Researchers are excited about RBX2660 because it represents a potential shift in how we manage C. diff, focusing on long-term gut health and sustainability.

What evidence suggests that RBX2660 might be an effective treatment for C. Diff infection?

Research has shown that RBX2660, the treatment under study in this trial, effectively treats repeat C. difficile infections (rCDI). Studies have found that it helps prevent these infections from recurring when used after standard antibiotics. In one trial, RBX2660 significantly reduced the chances of rCDI compared to a placebo. The treatment consistently performed well in multiple studies, demonstrating good results in maintaining long-term infection prevention. Overall, evidence supports RBX2660 as a reliable option for preventing the return of this challenging infection. ^{2 4 6 7 8}

Who Is on the Research Team?

Global Clinical Compliance

Principal Investigator

Ferring Pharmaceuticals

Are You a Good Fit for This Trial?

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)

Be a candidate for colonoscopy as judged by the investigator

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RBX2660 administered by colonoscopy to explore safety and clinical effectiveness

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9607700/

Efficacy and Safety of RBX2660 in PUNCH CD3, a Phase ... RBX2660 is a safe and effective treatment to reduce recurrent C. difficile infection following standard-of-care antibiotics with a sustained response through 6 ...

2. ferringusa.com ferringusa.com/?press=ferring-presents-complete-data-across-five-rbx2660-trials-demonstrating-consistent-and-durable-efficacy-in-recurrent-c-difficile-infection-as-well-as-multiple-analyses-demonstrating-positive-shifts

Ferring Presents Complete Data across Five RBX2660 ... Ferring Presents Complete Data across Five RBX2660 Trials Demonstrating Consistent and Durable Efficacy in Recurrent C. Difficile Infection, as ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03244644

Study Details | NCT03244644 | Microbiota Restoration ... The primary assessments for this study are (i) efficacy of RBX2660 as compared to a Placebo in preventing recurrent episodes of CDI and (ii) safety via ...

4. ferring.com ferring.com/ferring-and-rebiotix-present-landmark-phase-3-data-demonstrating-superior-efficacy-of-investigational-rbx2660-versus-placebo-to-reduce-recurrence-of-c-difficile-infection/

Ferring and Rebiotix Present Landmark Phase 3 Data ... RBX2660 pivotal Phase 3 trial successfully met the primary endpoint; data presented today at Digestive Disease Week® (DDW).

5. academic.oup.com academic.oup.com/cid/article/80/1/43/7740543

PUNCH CD3-OLS: A Phase 3 Prospective Observational ... Treatment success is defined as the absence of Clostridioides difficile infection (CDI) diarrhea through 8 weeks after RBL administration. b ...

6. ferringusa.com ferringusa.com/?press=pivotal-phase-3-efficacy-and-safety-data-for-ferrings-rbx2660-published-in-drugs

Pivotal Phase 3 Efficacy and Safety Data for Ferring's ... Investigational RBX2660 showed statistically significant treatment success at reducing CDI recurrence at eight weeks compared to placebo at ...

7. ferringusa.com ferringusa.com/?press=ferring-presents-new-subgroup-analyses-of-health-related-quality-of-life-and-safety-and-efficacy-data-at-idweek-2022-for-rbx2660

Ferring Presents New Subgroup Analyses of Health ... RBX2660 is an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrence of C. difficile infection ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38989699/

Fecal microbiota live - jslm (Rebyota™/RBL) for ... Rebyota™, formerly known as RBX2660, is a live biotherapeutic product designed using a standardized protocol and manufacturing process that has ...