Trials / Completed
CompletedNCT03531892
A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis
Phase III Study of AJM300 in Patients With Active Ulcerative Colitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 198 (actual)
- Sponsor
- EA Pharma Co., Ltd. · Industry
- Sex
- All
- Age
- 16 Years – 74 Years
- Healthy volunteers
- Not accepted
Summary
The study will investigate the efficacy and safety of an oral dose of AJM300 960 milligram (mg)/dose administered three times daily for 8 weeks in participants with active ulcerative colitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AJM300 | AJM300 film-coated tablets. |
| DRUG | Placebo | Placebo matched to AJM300 tablets. |
Timeline
- Start date
- 2018-06-06
- Primary completion
- 2020-11-09
- Completion
- 2023-03-28
- First posted
- 2018-05-22
- Last updated
- 2023-07-21
Locations
82 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03531892. Inclusion in this directory is not an endorsement.