NCT03244644

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)

A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of RBX2660 (Microbiota Suspension) for the Prevention of Clostridium Difficile Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Rebiotix Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe Clostridioides difficile infection (CDI) resulting in hospitalization within the last year may be eligible for the study. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded dose of RBX2660.

Detailed description

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. The primary assessments for this study are (i) efficacy of RBX2660 as compared to a Placebo in preventing recurrent episodes of CDI and (ii) safety via assessment of adverse events. The primary efficacy analysis of the study will be a Bayesian hierarchical model, which formally incorporates data from a previous randomized Phase 2b study (Protocol 2014-01, NCT02299570) of RBX2660. Follow-up office visits occur at weeks 1-, 4- and 8 after completing the blinded study treatment. Telephone assessments for adverse events occur during weeks 2, 3 and 6 after the study treatment and at months 3 and 6. Patients who have had at least one recurrence after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization within the last year may be eligible for the study. Study Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded dose of RBX2660.

Conditions

• Clostridium Difficile Infection (CDI)

Interventions

Type	Name	Description
DRUG	RBX2660	RBX2660 is a rectally administered microbiota suspension
DRUG	Placebo	Placebo is normal saline solution administered rectally
DRUG	Open label RBX2660 (only for confirmed CDI recurrence)	RBX2660 administered as a second treatment after confirmed CDI recurrence following the initial dose of placebo or RBX2660

Timeline

• Start date: 2017-07-31
• Primary completion: 2020-04-02
• Completion: 2020-08-03
• First posted: 2017-08-09
• Last updated: 2024-07-10
• Results posted: 2023-08-14

Locations

66 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study