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a first multi-center, randomized, doubleblind, placebo-controlled, parallel group initial Phase III study (the “MAP US Study”) to assess the efficacy and safety of fixed-dose combination RHB-104 in subjects with moderately to severely active Crohn’s disease. The primary endpoint for this study is the state of remission at week 26 in subjects randomized to receive RHB-104, as compared to subjects randomized to receive placebo. Secondary and exploratory endpoints will include, among others, state ofresponse at 26 weeks, maintenance of remission through week 52 and efficacy outcome measures in relation to presence of MAP (Mycobacterium avium paratuberculosis) bacterial infection.
The lead investigator for the MAP US study will be Professor David Y. Graham, MD
from Baylor College of Medicine, Houston, Texas. Professor Graham is a prominent
gastroenterologist and internationally recognized researcher.