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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03931941
Acronym
CD3-OLS
Enrollment
793
Registered
2019-04-30
Start date
2019-07-30
Completion date
2023-07-21
Last updated
2024-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile Infection, Communicable Diseases, Infection

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

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.

Interventions

DRUGRBX2660

RBX2660 is a microbiota suspension administered as an enema

Sponsors

Rebiotix Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Safety and Tolerability of RBX2660 in Subjects With Recurrent CDI.Up to 6 months after last study treatment.Number of subjects with investigational product- and/or enema-related treatment-emergent adverse events (TEAEs).

Secondary

MeasureTime frameDescription
Efficacy of RBX2660 Measured at 8 Weeks After Treatment.8 weeks after completing the study treatmentThe 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.6 months after completing the study treatmentTreatment 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.

Countries

Canada, United States

Participant flow

Recruitment details

Recruitment was from July 2019 to July 2023 at 56 sites in the US and Canada. Recruitment was performed by trained investigators and study coordinators.

Pre-assignment details

A total of 793 participants were enrolled/signed informed consent of which 95 were screen failures. 698 subjects were enrolled and were not screen failures. One participant was enrolled but not treated, therefore 697 participants received a dose of RBX2660.

Participants by arm

ArmCount
RBX2660
RBX2660 is a rectally administered microbiota suspension RBX2660: RBX2660 is a microbiota suspension administered rectally
697
Total697

Baseline characteristics

CharacteristicRBX2660
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
338 Participants
Age, Categorical
Between 18 and 65 years
359 Participants
Age, Continuous61.1 years
STANDARD_DEVIATION 17.32
Ethnicity (NIH/OMB)
Hispanic or Latino
15 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
670 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
12 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
7 Participants
Race (NIH/OMB)
Black or African American
21 Participants
Race (NIH/OMB)
More than one race
4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
10 Participants
Race (NIH/OMB)
White
654 Participants
Region of Enrollment
Canada
117 participants
Region of Enrollment
United States
580 participants
Sex: Female, Male
Female
487 Participants
Sex: Female, Male
Male
210 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
6 / 697
other
Total, other adverse events
265 / 697
serious
Total, serious adverse events
87 / 697

Outcome results

Primary

Safety and Tolerability of RBX2660 in Subjects With Recurrent CDI.

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

Time frame: Up to 6 months after last study treatment.

Population: Safety

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Active TreatmentSafety and Tolerability of RBX2660 in Subjects With Recurrent CDI.697 Participants
Secondary

Efficacy of RBX2660 Measured at 8 Weeks After Treatment.

The absence of C. difficile diarrhea without the need for retreatment through 8 weeks after administration of the study treatment.

Time frame: 8 weeks after completing the study treatment

Population: Modified Intent-to-Treat (MITT)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Active TreatmentEfficacy of RBX2660 Measured at 8 Weeks After Treatment.499 Participants
Secondary

Sustained Clinical Response Through 6 Months After 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.

Time frame: 6 months after completing the study treatment

Population: Modified Intent-to-Treat

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Active TreatmentSustained Clinical Response Through 6 Months After Treatment.454 Participants

Source: ClinicalTrials.gov · Data processed: Jun 14, 2026