drugset / Trial / NCT03412682
To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis
RandomizedParallel-groupDouble-blindTreatment
Summary
To demonstrate non-inferiority in efficacy of FE 999315 to mesalazine in patients with mild to moderate active ulcerative colitis after 8 weeks of treatment.
Timeline
- Start
- 2018-03-02
- Primary completion
- 2020-05-11
- Completion
- 2020-05-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | 6 mg | — |
| Subject | Budesonide | Small molecule | 9 mg | — |
| Comparator | Mesalamine | Small molecule | 400 mg | — |
| Comparator | Mesalamine | Small molecule | 3600 mg | — |