A 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 Crohn's Disease
Phase of Trial: Phase III
Latest Information Update: 02 Oct 2017
At a glance
- Drugs Clarithromycin/clofazimine/rifabutin (Primary)
- Indications Crohn's disease; Mycobacterium avium paratuberculosis infections
- Focus Registrational; Therapeutic Use
- Acronyms MAP-US; MAPUS
- Sponsors RedHill Biopharma
- 02 Oct 2017 According to a RedHill Biopharma media release, if the result of this study will be positive, data will be discussed with FDA.
- 02 Oct 2017 According to a RedHill Biopharma media release, 322 subjects have been enrolled, and completion of enrollment is expected by Nov 2017 and top-line results expected in mid-2018
- 02 Oct 2017 According to a RedHill Biopharma media release, planned number of patients changed from 410 to 325. The company reported that it has sufficient enrolment in the study to demonstrate efficacy within the protocol-defined 15% treatment effect .