drugset / Trial / NCT03861143
Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open-label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.
Timeline
- Start
- 2019-08-14
- Primary completion
- 2020-12-10
- Completion
- 2021-06-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | omilancor | Small molecule | 440 mg | Oral |
| Subject | omilancor | Small molecule | 880 mg | Oral |