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

• CP101 (Biological), also known as Full-Spectrum Microbiota™: 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.

Primary outcomes

• 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 outcomes

• 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.

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication (Primary), Count of participants, Participants: CP101 106
• Occurence of Treatment Emergent Adverse Events (TEAEs) (Primary), Count of participants, Participants: CP101 88
• Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication (Secondary), Count of participants, Participants: CP101 104

Adverse events

Time frame: Up to Week 24

Serious adverse events by term

Other adverse events by term

• Study Protocol (PDF, 2019-12-20)
• Statistical Analysis Plan (PDF, 2021-04-05)

• Zain Kassam, MD, MPH, Study director, Finch Therapeutics