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

Trial Profile

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

Recruiting
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
  • Most Recent Events

    • 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 .
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