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

A Randomized, Double-blind, Placebo Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous Administration of Secukinumab (AIN457) in Patients With Asthma Not Adequately Controlled With Inhaled Corticosteroids and Long Acting Beta-agonists.

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.

Inclusion Criteria:

• Adult patients with asthma >1 year duration diagnosed according to the GINA guidelines (GINA 2010).
• Daily treatment with > 1000μg beclomethasone dipropionate or equivalent, plus a long acting beta agonist for ≥ 3 months prior to Day 1, that has been stable for at least 4 weeks prior to screening.
• Asthma which is not adequately controlled on current treatment
• Peripheral blood eosinophil count < 400/μl at screening

Exclusion Criteria:

• Women of child-bearing potential unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.
• Use of other investigational drugs at the time of screening, or within 30 days of screening.
• Smokers