Rebiotix Inc, a Ferring company, is seeking investigators with clinical research experience and interest in C. difficile infection to participate in a Phase 3 Open-Label Safety and Tolerability Study.
Rebiotix is seeking clinical investigators with interest in C. difficile infection and other microbiome-related clinical research. To help us better understand your interest in clinical trial participation, please provide the following information:
A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (microbiota suspension) in Subjects with Recurrent Clostridium difficile Infection.
The primary objective is to evaluate the safety and tolerability of RBX2660 in subjects with recurrent CDI.
Study treatment consists of a single study enema of RBX2660. Study subjects who are deemed treatment failures may elect to receive another enema of RBX2660. There is no placebo drug given as part of this study.
Follow-up includes in-office visits at weeks 1 and 8 after receiving RBX2660, and follow-up phone calls through 6 months.
RBX2660 is a broad spectrum, microbiota suspension prepared from thoroughly screened healthy human donors and is administered to subjects by enema.
RBX2660 has previously been studied in three Phase 2 regulated clinical trials and has been granted Fast Track status, Orphan Drug and Breakthrough Therapy designation from the FDA.
Further information is available at ClinicalTrials.gov/ (NCT03931941)
About the Sponsor
Rebiotix Inc, a Ferring Company, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases.
2660 Patton Road
Roseville, MN 55113