drugset / Trial / NCT01478360
Safety, Tolerability, and Efficacy of AIN457 in Patients With Uncontrolled Asthma
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is a preliminary proof of efficacy study of AIN457 in patients with bronchial asthma that is poorly controlled with the current standard of care.
Timeline
- Start
- 2012-03
- Primary completion
- 2014-11
- Completion
- 2014-11
Outcome
Missed primary endpoint
Stopped: “Further investigations would require changes in study design; the use of different endpoints, a different IL-17 antibody or a different patient population.”
registry analysis (superiority or other test); AIN457 vs Placebo; p = 0.5392; Mean Difference (Net) -0.166 (90% CI -0.617 to 0.285); Mixed Models Analysis NCT01478360 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Secukinumab | Monoclonal antibody | 10 mg/kg | Intravenous |