Phase III study of AJG511 in patients with active ulcerative colitis
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
- 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.