Clinical Trial of RedHill’s Potential Crohn’s Disease Therapy Set to Continue as Planned

Clinical Trial of RedHill’s Potential Crohn’s Disease Therapy Set to Continue as Planned
RedHill Biopharma announced that an independent Data and Safety Monitoring Board (DSMB) recommended the company's MAP US clinical trial to continue as planned without any modifications. MAP US is an ongoing Phase 3 clinical trial (NCT01951326) testing RHB-104, a combination of antibiotics: rifabutin and clarithromycin with clofazamine, for the treatment of Crohn’s disease. It is a randomized, double-blind placebo-controlled study, meaning the participants are randomly allocated to either the drug or a placebo, and that neither they nor the clinicians know who is receiving the drug and who is receiving a placebo. The aim of the trial is to evaluate the safety and effectiveness of RHB-104 in people with moderate to severe Crohn’s disease. The company reported that more than half the planned number of participants (242 of 410) have already been enrolled for the study in up to 150 sites across the U.S., Canada, Europe, Israel, Australia and New Zealand. The effectiveness of the drug will be determined by measuring disease remission defined as a reduction in the Crohn’s Disease Activity Index (CDAI) to less than 150 at week 26 (all patient had a CDAI between 220 and 450 at the beginning of the trial). "Additional studies will be required to support a U.S. New Drug Application (NDA) for RHB-104," the company wrote in a
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