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CP101

Phase 2

Clostridium Difficile Infection | Monoclonal antibody | Infectious Disease |Medpace Holdings, Inc. Common Stock|Last Updated: Aug 30, 2022

Development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Apr 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment132

FDA Designations

No designations recorded

Clinical trial landscape

CP101 · 1 trial · 11 indications

Phase 2 1
NCT03497806Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile InfectionClostridium Difficile Infection
COMPLETED132 Analytics
PHASE2COMPLETED
Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
Clostridium Difficile Infection
NCT03497806132
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Study Endpoints

Primary Endpoints

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 Endpoints

Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication
Up to Week 24
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
High Dose CP101EXPERIMENTALThe 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.

Interventions

NameTypeDescription
CP101BIOLOGICALStudy 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites57

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...

Countries:United StatesCanada
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