Phase III study of AJG511 in patients with active ulcerative colitis

Trial Profile

Phase III study of AJG511 in patients with active ulcerative colitis

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Sep 2017

At a glance

  • Drugs Budesonide (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Sponsors EA Pharma
  • Most Recent Events

    • 27 Sep 2017 Primary endpoint (Mucosal healing rates) has been met, according to a Kissei Pharmaceutical media release.
    • 27 Sep 2017 According to a Kessei Pharmaceuticals media release, EA Pharma has obtained marketing approval for "RECTABUL 2 mg Rectal Foam 14 Doses" for the treatment of ulcerative colitis in Japan. The approval was based on data from this trial.
    • 28 Oct 2016 Status changed from active, no longer recruiting to completed.
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