Facilitated By

San Antonio Medical Foundation

A Phase III Randomized, Double-Blind Placebo-Controlled, Multicenter, Parallel Group Study To Assess The Efficacy And Safety Of Fixed-Dose Combination Rhb-104 In Subjects With Moderately To Severely Active Crohns Disease

Brooke Army Medical Center

Brooke Army Medical Center (BAMC) at Fort Sam Houston, Texas, is proud to provide safe, quality care to our military service members, their families, veterans and civilian emergency patients as the most robust and productive healthcare organization within the Military Health System (MHS).

Principal Investigator(s)
Email for information
Funded by
Geneva
Research Start Date
Status
Active

This study is a multicenter, Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of RHB-104 compared to placebo to treat subjects with moderate to severe CD. RHB-104 consists of 3 antibiotics with activity against Mycobacterium avium subsp. paratuberculosis (MAP), a potential cause of CD. Subjects with active CD will be randomized at baseline in a 1:1 fashion to receive up to 52 weeks of RHB-104 or placebo. Subjects will remain on stable doses of their baseline CD treatment although steroids may be tapered after Week 8 at the discretion of the investigator.

Clinical Care
Infectious Disease
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