drugset / Trial / NCT03733314
A Study of E6011 in Participants With Active Crohn's Disease
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary purpose of this study is to examine the efficacy and safety of E6011 at 12 weeks after administration by means of double-blind placebo-controlled trial.
Timeline
- Start
- 2019-04-25
- Primary completion
- 2022-03-16
- Completion
- 2024-04-03
Outcome
Missed primary endpoint
registry analysis (superiority test); E6011 10 mg/kg vs Placebo Then E6011 10 mg/kg; Difference 10.3 (95% CI -24.9 to 45.4) NCT03733314 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | QUETMOLIMAB | Monoclonal antibody | — | Intravenous |