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

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

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.

Study Overview

• Status: Completed
• Conditions: Clostridium Difficile Infection; Recurrent Clostridium Difficile Infection; C. Diff; CDI; Recurrent C. Diff; rCDI; C. Difficile; Recurrent CDI; FMT; Fecal Microbiota; Fecal Transplant
• Intervention / Treatment: Biological: CP101

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Calgary
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H4C5
      • Halifax
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • London
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85054
      • Scottsdale
  • California
    • Los Angeles, California, United States, 90095
      • Los Angeles
    • Murrieta, California, United States, 92563
      • Murrieta
    • Oakland, California, United States, 94705
      • Oakland
    • San Diego, California, United States, 92123
      • San Diego
    • San Francisco, California, United States, 94115
      • San Francisco
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Aurora
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport
    • Hamden, Connecticut, United States, 06518
      • Hamden
  • District of Columbia
    • Washington, District of Columbia, United States, 20422
      • Washington DC
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Jacksonville
    • Naples, Florida, United States, 34102
      • Naples
    • Pinellas Park, Florida, United States, 33781
      • Pinellas Park
    • Tampa, Florida, United States, 33614
      • Tampa
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Atlanta
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Idaho Falls
  • Illinois
    • Burr Ridge, Illinois, United States, 60527
      • Burr Ridge
    • Chicago, Illinois, United States, 60637
      • Chicago
    • Evanston, Illinois, United States, 60201
      • Evanston
    • Maywood, Illinois, United States, 60153
      • Maywood
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indianapolis
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • West Des Moines
  • Kansas
    • Shawnee Mission, Kansas, United States, 66217
      • Shawnee
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • New Orleans
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Detroit
    • Royal Oak, Michigan, United States, 48073
      • Royal Oak
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Rochester
    • Saint Paul, Minnesota, United States, 55102
      • St. Paul
  • Montana
    • Butte, Montana, United States, 59701
      • Butte
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown
    • Somers Point, New Jersey, United States, 08244
      • Somers Point
  • New York
    • Bronx, New York, United States, 10467
      • Bronx
    • New York, New York, United States, 10016
      • New York
    • New York, New York, United States, 10021
      • New York
    • New York, New York, United States, 10029
      • New York
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Chapel Hill
    • Kinston, North Carolina, United States, 28501
      • Kinston
    • Pinehurst, North Carolina, United States, 28374
      • Pinehurst
    • Winston-Salem, North Carolina, United States, 27103
      • Winston-Salem
    • Winston-Salem, North Carolina, United States, 27157
      • Winston-Salem
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Cincinnati
    • Poland, Ohio, United States, 44514
      • Poland
  • Oregon
    • Portland, Oregon, United States, 97239
      • Portland
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Providence
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Nashville
  • Texas
    • San Antonio, Texas, United States, 78229
      • San Antonio
  • Utah
    • Ogden, Utah, United States, 84403
      • Ogden
    • Salt Lake City, Utah, United States, 84124
      • Salt Lake City
  • Virginia
    • Annandale, Virginia, United States, 22003
      • Annandale
    • Charlottesville, Virginia, United States, 22908
      • Charlottesville
  • Washington
    • Seattle, Washington, United States, 98101
      • Seattle
  • Wisconsin
    • Grafton, Wisconsin, United States, 53024
      • Grafton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Dose CP101; 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; 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.; 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

Collaborators and Investigators

• Sponsor: Finch Research and Development LLC.
• Collaborators: Medpace, Inc.
• Investigators: Study Director: Zain Kassam, MD, MPH, Finch Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: FMT; CDI; Clostridium Difficile Infection; Fecal transplant; Fecal microbiota transplant; C. difficile; CP101; Crestovo; C. diff; Recurrent Clostridium Difficile Infection; Recurrent C. diff; Recurrent CDI; Finch; rCDI; Finch Therapeutics
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Recurrence; Clostridium Infections
• Other Study ID Numbers: CP101-CDI-E02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No