CDI, C. Diff, C. Difficile, Clostridium Difficile Infection, Fecal Microbiota, Fecal Transplant, FMT, rCDI, Recurrent CDI, Recurrent C. Diff, Recurrent Clostridium Difficile Infection
Conditions
Keywords
Clostridium Difficile Infection, CP101, Crestovo, FMT, CDI, C. difficile, C. diff, Recurrent Clostridium Difficile Infection, Recurrent C. diff, Recurrent CDI, Finch, Fecal transplant, Fecal microbiota transplant, rCDI, Finch Therapeutics
Brief summary
This is an open-label study evaluating the safety and efficacy of CP101 treatment in 1) Subjects in CDI-001 who had a CDI recurrence within 8 weeks of receiving CP101 or placebo; OR 2) adults with recurrent CDI who are eligible for direct study entry into CP101-CDI-E02. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be eligible to be enrolled in he study and administered CP101. Approximately 200 subjects will receive CP101. The treatment duration will be 1 day. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following receipt of CP101. The primary efficacy and safety endpoints will be evaluated at 8 weeks post treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of CDI.
Interventions
BIOLOGICALCP101
Study drug will be administered at Treatment (Day 1) as an oral dose after cessation of standard-of-care CDI antibiotic treatment of the current episode of recurrent CDI.
Sponsors
Medpace, Inc.
Finch Research and Development LLC.
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. Ability to provide written informed consent; 2. Previously enrolled in PRISM 3, had a CDI recurrence within 8 weeks of receiving CP101 or placebo, and have completed their PRISM 3 end of study visit; OR recurrent CDI 3. An outpatient prior to Treatment 4. Has received a course of standard-of-care CDI antibiotics for the most recent CDI episode, has had an adequate clinical response, and has completed a washout period.
Exclusion criteria
1. Pregnant, breast-feeding, or considering becoming pregnant during the study 2. Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis) 3. Any prior diagnosis of diarrhea-predominant irritable bowel syndrome 4. Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization 5. Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study 6. Major intra-abdominal surgery within the past 60 days prior to Screening 7. Admitted to, or expected to be admitted to an intensive care unit for any medical reason. Note: Residents of long term care facilities are eligible study entry 8. History of total colectomy/ileostomy or bariatric surgery 9. Planned hospitalization or invasive surgery during the study 10. Severe acute illness unrelated to CDI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication | Up to Week 8 | Defined in the protocol as sustained clinical cure. Clinical cure means a patient did not experience a recurrence of C. diff during this time period. |
| Occurence of Treatment Emergent Adverse Events (TEAEs) | Week 8 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication | Up to Week 24 | Defined in the protocol as sustained clinical cure. Clinical cure means a patient did not experience a recurrence of C. diff during this time period. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CP101 Full Spectrum Microbiota Capsule, Full Spectrum Microbiota: Orally administered donor derived microbiota | 132 |
| Total | 132 |
Baseline characteristics
| Characteristic | CP101 |
|---|---|
| Age, Continuous | 66 Years STANDARD_DEVIATION 15.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 126 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 127 Participants |
| Region of Enrollment Canada | 9 participants |
| Region of Enrollment United States | 123 participants |
| Sex: Female, Male Female | 99 Participants |
| Sex: Female, Male Male | 33 Participants |
| Total number of C. difficile Infection (CDI) episodes in previous 6 months 1 | 2 Participants |
| Total number of C. difficile Infection (CDI) episodes in previous 6 months 2 | 44 Participants |
| Total number of C. difficile Infection (CDI) episodes in previous 6 months 3 | 49 Participants |
| Total number of C. difficile Infection (CDI) episodes in previous 6 months >3 | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 132 |
| other Total, other adverse events | 97 / 132 |
| serious Total, serious adverse events | 17 / 132 |
Outcome results
Primary
Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication
Defined in the protocol as sustained clinical cure. Clinical cure means a patient did not experience a recurrence of C. diff during this time period.
Time frame: Up to Week 8
Population: mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CP101 | Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication | 106 Participants |
Primary
Occurence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Week 8
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CP101 | Occurence of Treatment Emergent Adverse Events (TEAEs) | 88 Participants |
Secondary
Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication
Defined in the protocol as sustained clinical cure. Clinical cure means a patient did not experience a recurrence of C. diff during this time period.
Time frame: Up to Week 24
Population: mITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CP101 | Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication | 104 Participants |