A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)

Study Overview
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Brief Summary
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This is a Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides difficile Infection (PRISM4). This Phase 3 trial will be conducted in 2 parts: a randomized, double-blind, placebo-controlled trial arm and an optional open-label treatment arm. After completing standard-of-care (SOC) CDI antibiotics for their most recent CDI recurrence, patients who meet all eligibility requirements will be randomized in a 2:1 ratio to receive either CP101 or placebo. Patients will be evaluated for CDI recurrence and safety follow-up through Week 8, the primary endpoint, as well as through Week 24. Patients who qualify may enroll into the optional open label arm if they experience CDI recurrence through week 8.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides Difficile Infection (CDI)

Conditions
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Recurrent C. Difficile Infection

Intervention / Treatment
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* Biological: CP101
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide written informed consent Men or women over 18 years of age or older Current diagnosis of a recurrence of non-severe, non-complicated CDI Subject has a clinical response to standard-of-care CDI antibiotics for the most recent CDI episode History of recurrent CDI defined as: ≥ 3 episodes of CDI, with 2 episodes occurring within the previous 6 months (inclusive of the current episode); OR Patients with a history of 2 episodes of CDI occurring within the previous 6 months (inclusive of the current episode) may be eligible if 65 years of age or older. For the Qualifying CDI episode, the following criteria must be satisfied: History of diarrhea (> 3 unformed stools per day) for 2 or more consecutive days that is clinically consistent with CDI. AND Documented positive stool test by local laboratory for toxigenic C. difficile (toxin enzyme immunoassay [EIA] or polymerase chain reaction [PCR]-based testing) for the current CDI episode and within 45 days prior to Randomization. AND Received a course of SOC CDI antibiotics for the most recent CDI episode (for 10 to 21 days, with exact duration, antibiotic type, and dose at the discretion of the Investigator). AND Demonstrated an adequate clinical response, defined as ≤ 3 unformed stools in 24 hours for 2 or more consecutive days during SOC CDI antibiotics prior to Randomization. Exclusion Criteria: Known stool sample testing positive for enteric pathogen(s) (e.g., Salmonella, Shigella, diarrhoeagenic E. coli, Campylobacter, Giardia) within 28 days prior to Screening Pregnant, breast-feeding, or planning to become pregnant during the trial Historical or current diagnosis of inflammatory bowel disease Recent diagnosis (<6 months prior to screening) of diarrhea-predominant irritable bowel syndrome (post-infection or non-related to an enteric infection) Initiation of any systemic cancer treatment (e.g., chemotherapy, radiotherapy, biologic, immunotherapy, others) for active malignancy Major intra-abdominal surgery (e.g., bowel resection) Known primary or secondary immunodeficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CP101<br> | Biological: CP101<br>* CP101 is an investigational microbiome therapeutic designed to deliver a complete and functional microbiome to durably repair intestinal dysbiosis, which is being evaluated for the prevention of recurrent Clostridioides difficile infection (CDI).<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Clinical Cure Through Week 8 | No data displayed because Outcome Measure has zero participants analyzed. | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Clinical Cure Through Week 24 | No data displayed because Outcome Measure has zero participants analyzed. | Week 24 | 
| CDI Recurrence Through Week 24 as Evidenced by Positive Toxin EIA or Positive Toxigenic Culture | No data displayed because Outcome Measure has zero participants analyzed. | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FMT, Fecal microbiota transplant, Fecal transplant, CDI, C. difficile infection, recurrent Clostridium difficile infection, Clostriodioides difficile infection, recurrent C. diff infection, multiple recurrent C. diff infection, c. diff, microbiota transplantation, Fecal microbiota transplantation