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

NCT05153499 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: FIN-CDI-301
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 68

Brief Summary

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.

Conditions

Recurrent C. Difficile Infection

Keywords

C. difficile infection; recurrent Clostridium difficile infection; Clostriodioides difficile infection; recurrent C. diff infection; multiple recurrent C. diff infection; CDI; c. diff; microbiota transplantation; FMT; Fecal microbiota transplantation; Fecal microbiota transplant; Fecal transplant

Outcome Measures

Primary Outcomes (1)

• Sustained Clinical Cure Through Week 8

  No data displayed because Outcome Measure has zero participants analyzed.

  Week 8

Secondary Outcomes (2)

• Sustained Clinical Cure Through Week 24

  Week 24

• CDI Recurrence Through Week 24 as Evidenced by Positive Toxin EIA or Positive Toxigenic Culture

  Week 24

Other Outcomes (1)

• Improvement of Intestinal Microbiome Diversity at Week 1 as Determined by 16S Ribosomal Ribonucleic Acid (rRNA) Gene Amplicon Sequencing

  Week 1

Study Arms (2)

CP101

ACTIVE COMPARATOR

Biological: CP101

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

CP101 BIOLOGICAL

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).

CP101

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Finch Research and Development LLC.: lead

Study Sites (68)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Facey Medical Foundation

Mission Hills, California, 91345, United States

Location

Kaiser Permanente Division of Research

Oakland, California, 94611, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

Stanford Healthcare

Stanford, California, 94305, United States

Location

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Medical Research Center of Connecticut LLC

Hamden, Connecticut, 06518, United States

Location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Christiana Care Health System

Newark, Delaware, 19718, United States

Location

George Washington University School of Medicine and Health

Washington D.C., District of Columbia, 20052, United States

Location

University of Florida Health

Gainesville, Florida, 32608, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

ENCORE Borland-Groover Clinical Research

Jacksonville, Florida, 32256, United States

Location

San Marcus Research Clinic Inc

Miami, Florida, 33014, United States

Location

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Reliant Medical Research

Miami, Florida, 33165, United States

Location

Gastroenterology Group of Naples

Naples, Florida, 34102, United States

Location

Theia Clinical Research, LLC

St. Petersburg, Florida, 33709, United States

Location

Guardian Angel Research

Tampa, Florida, 33614, United States

Location

St Joseph's Comprehensive Research Institute

Tampa, Florida, 33614, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Snake River Research, PLLC

Idaho Falls, Idaho, 83404, United States

Location

Metro Infectious Disease Consultants

Burr Ridge, Illinois, 60527, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60077, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Iowa Clinic

Des Moines, Iowa, 50266, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

William Beaumont Hospital

Farmington Hills, Michigan, 48336, United States

Location

Henry Ford Health System

Novi, Michigan, 48377, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MedPharmics LLC

Gulfport, Mississippi, 39503, United States

Location

St. Charles Clinical Research, LLC

Weldon Spring, Missouri, 63304, United States

Location

Mercury Street Medical Group

Butte, Montana, 59701, United States

Location

North Shore University Hospital-(Manhasset)

Manhasset, New York, 11030, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Digiovanna Institute For Medical Education and Research

North Massapequa, New York, 11758, United States

Location

Central New York Research Corporation

Syracuse, New York, 13210, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Brody School of Medicine at ECU

Greenville, North Carolina, 27834, United States

Location

Pinehurst Medical Clinic Inc

Pinehurst, North Carolina, 28374, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Gastro Health LLC

Cincinnati, Ohio, 45219, United States

Location

TruCare Internal Medicine & Infectious Diseases

DuBois, Pennsylvania, 15801, United States

Location

Regional GI

Lancaster, Pennsylvania, 17601, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Guthrie Clinic

Sayre, Pennsylvania, 18840, United States

Location

Women's Medicine Collaborative

Providence, Rhode Island, 02904, United States

Location

Lowcountry Infectious Diseases PA

Charleston, South Carolina, 29414, United States

Location

Main Street Physicians Care

Loris, South Carolina, 29569, United States

Location

Digestive Health Associates of Texas, PA

Carrollton, Texas, 75010, United States

Location

Kelsey Seybold Clinic

Houston, Texas, 77025, United States

Location

1960 Family Practice P.A.

Houston, Texas, 77090, United States

Location

Southern Star Research Institute LLC

San Antonio, Texas, 78229, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Infectious Diseases Associates of Central Virginia

Lynchburg, Virginia, 24501, United States

Location

University of Calgary - Calgary Health Region

Calgary, Alberta, T2N 4N1, Canada

Location

CARe Clinic

Red Deer, Alberta, T4P 1K4, Canada

Location

Yazdan Medical Corporation

Vancouver, British Columbia, V7M 1Z8, Canada

Location

Vancouver Island Health Authority

Victoria, British Columbia, V8R 1J8, Canada

Location

Dalhousie University

Halifax, Nova Scotia, B3H 4R2, Canada

Location

Saint Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

Location

University Health Network

Toronto, Ontario, M5G 1L7, Canada

Location

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Limitations and Caveats

Study was terminated early. Most analyses were not performed.

Results Point of Contact

• Title: CEO
• Organization: Finch Therapeutics

info@finchtherapeutics.com

617-229-6499

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 10, 2021
• Study Start: November 15, 2021
• Primary Completion: February 24, 2023
• Study Completion: February 24, 2023
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-10

Locations

US (61); CA (7)