Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection

Study Overview
=================
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.

Official Title
-----------------
PRISM-EXT: An Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection

Conditions
-----------------
C. Diff, Clostridium Difficile Infection, Recurrent Clostridium Difficile Infection, CDI, Recurrent C. Diff, rCDI, C. Difficile, Recurrent CDI, FMT, Fecal Microbiota, Fecal Transplant

Intervention / Treatment
-----------------
* Biological: CP101


Participation Criteria
=================
Eligibility Criteria
-----------------
Ability to provide written informed consent; 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 An outpatient prior to Treatment 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: Pregnant, breast-feeding, or considering becoming pregnant during the study Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis) Any prior diagnosis of diarrhea-predominant irritable bowel syndrome Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study Major intra-abdominal surgery within the past 60 days prior to Screening 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 History of total colectomy/ileostomy or bariatric surgery Planned hospitalization or invasive surgery during the study Severe acute illness unrelated to CDI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dose CP101<br>The active ingredient of CP101, Full-Spectrum Microbiota™, is derived from the stools of normal healthy donors who are highly screened, tested, and monitored in a clinically structured donation program. | Biological: CP101<br>* 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.<br>* Other names: Full-Spectrum Microbiota™;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to Week 8 | 
| Occurence of Treatment Emergent Adverse Events (TEAEs) |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to Week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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