drugset / Trial / NCT01478360

Safety, Tolerability, and Efficacy of AIN457 in Patients With Uncontrolled Asthma

NCT01478360 ↗

Phase 2 Terminated 46 enrolled Novartis Pharmaceuticals
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

EvaluationDrugModalityDoseRoute
Subject Secukinumab Monoclonal antibody 10 mg/kg Intravenous

Indications