Safety, Tolerability, and Efficacy of AIN457 in Patients With Uncontrolled Asthma
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/13/2015 |
| Start Date: | March 2012 |
| End Date: | November 2014 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | 1-888-669-6682 |
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.
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
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