Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS) (CD3-OLS)

• ClinicalTrials.gov Identifier: NCT03931941
• Recruitment Status: Active, not recruiting
• First Posted: April 30, 2019
• Last Update Posted: April 10, 2023
• Sponsor: Rebiotix Inc.
• Information provided by (Responsible Party): Rebiotix Inc.

Tracking Information

• First Submitted Date: April 26, 2019
• First Posted Date: April 30, 2019
• Last Update Posted Date: April 10, 2023
• Actual Study Start Date: July 30, 2019
• Estimated Primary Completion Date: September 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 26, 2019)

Safety and tolerability of RBX2660 in subjects with recurrent CDI. [ Time Frame: Up to 6 months after last study treatment. ]

Number of subjects with investigational product- and/or enema-related treatment-emergent adverse events (TEAEs).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 26, 2019)

• Efficacy of RBX2660 measured at 8 weeks after treatment. [ Time Frame: 8 weeks after completing the study treatment ]
  The absence of C. difficile diarrhea without the need for retreatment through 8 weeks after administration of the study treatment.
• Sustained clinical response through 6 months after treatment. [ Time Frame: 6 months after completing the study treatment ]
  Treatment success of the presenting CDI recurrence and no new CDI episodes for greater than 8 weeks through 6 months after completing a study treatment assessed by subject phone interview up to 6 months after the last study treatment.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
• Official Title: A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (Microbiota Suspension) in Subjects With Recurrent Clostridium Difficile Infection
• Brief Summary: This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.
• Detailed Description: This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. The primary assessments for this study are (i) safety via assessment of treatment-emergent adverse events and (ii) efficacy of RBX2660 preventing recurrent episodes of CDI measured at 8 weeks after treatment. Follow-up office visits occur at 1 week and 8 weeks after completing the initial study treatment. Telephone assessments occur at 4 weeks, and 4 and 6 months after the study. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Clostridium Difficile Infection
• Infection
• Communicable Diseases

Intervention

Drug: RBX2660

RBX2660 is a microbiota suspension administered as an enema

Other Name: Microbiota suspension

Study Arms

Experimental: Active

RBX2660 is an enema of a microbiota suspension

Intervention: Drug: RBX2660

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 7, 2023): 817
• Original Estimated Enrollment (submitted: April 26, 2019): 200
• Estimated Study Completion Date: September 2023
• Estimated Primary Completion Date: September 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. ≥ 18 years old.
2. Medical record documentation of either: a) a current diagnosis or history of recurrent CDI as determined by the treating physician, b) or has had at least two episodes of severe CDI resulting in hospitalization.
3. Is currently taking or was just prescribed antibiotics to control CDI related diarrhea at the time of enrollment. [Note: Subject's CDI diarrhea must be controlled (<3 unformed/loose stools/day) while taking antibiotics during screening.]

Exclusion Criteria:

1. Has continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment.
2. Requires systemic antibiotic therapy for a condition other than CDI.
3. Fecal microbiota transplant (FMT) within the past 6 months.
4. FMT with an associated serious adverse event related to the FMT product or procedure.
5. Bezlotoxumab (CDI monoclonal antibodies) if received within the last year.
6. CD4 count <200/mm^3 during Screening.
7. An absolute neutrophil count of <1000 cells/µL during Screening.
8. Pregnant, breastfeeding, or intends to become pregnant during study participation.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT03931941
• Other Study ID Numbers: 2019-01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Rebiotix Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Rebiotix Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Teena Chopra, M.D., M.P.H.; Wayne State University

• PRS Account: Rebiotix Inc.
• Verification Date: April 2023