PUNCH™ CD - Phase 3 Study Design Now Under Discussion
A Randomized Blinded Trial to Assess the Safety and Efficacy of RBX2660 (microbiota suspension) for the Treatment of Recurrent Clostridium difficile-Associated Diarrhea.
Now that enrollment in the PUNCH CD Phase 2 study has been completed, Rebiotix is working with the US Food and Drug Administration on the design for the Phase 3 study of its groundbreaking drug candidate RBX2660.
About the Study
The primary objectives of the Phase 3 study will be to study the safety and efficacy of RBX2660 for the treatment of recurrent Clostridium difficile-(C diff) associated diarrhea in the setting of a randomized multicenter study.
RBX2660 is the first in a new category of biologic drugs containing live human-derived microbes intended to treat challenging gastrointestinal disorders. The drug is patterned after fecal transplant therapy (FTT) which has been demonstrated 90% effective in treating Clostridium difficile-associated diarrhea.
The Rebiotix drug has been designed to incorporate several advantages over FTT.
How to Enroll as a Participant
Either check back or register for Phase 3 study updates for more information on eligibility criteria and clinical study sites.
Find Out If You Could be Eligible
Take a brief survey that will take less than 1 1/2 minutes to complete to learn if you might qualify for the clinical study.
For Information on Participation as a PUNCH CD Clinical Study Site
- Mary Kay Sobcinski, RN, MHA
Director of Clinical Operations
|RBX2660 is an investigational product not available for sale.|