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

• Status: Terminated
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal

Criteria

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