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: 12 Aug 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

    • 31 Jul 2017 According to a RedHill Biopharma media release, A third, safety-focused, independent DSMB meeting is expected to be held when 75% of the planned 410 subjects have completed 26 weeks of study participation.
    • 31 Jul 2017 According to a RedHill Biopharma media release, Data and Safety Monitoring Board (DSMB) has reviewed data from the first 222 subjects who have completed week 26 assessments and recommended to continue this study.
    • 12 Jul 2017 According to a RedHill Biopharma media release, company has completed the enrollment of approximately 300 out of the 410 subjects and completion of recruitment is expected by the beginning of 2018.
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