Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
This study aims to determine the efficacy and safety of QAW039 (Dose 1 and Dose 2), compared
 with placebo, when added to GINA steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA
 2015) in each of the groups (patients with severe asthma and high eosinophil counts and all
 patients with severe asthma)
A double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses
 (Dose 1 and Dose 2) of QAW039 compared with placebo over a 52-week treatment period in in
 each of the groups (patients with severe asthma and high eosinophil counts and all patients
 with severe asthma). Efficacy will be measured by the rate of asthma exacerbations. In
 addition, asthma quality of life score, asthma control score and lung function will be
 assessed. Safety will be assessed by adverse event monitoring.
Inclusion Criteria:

 -  Written informed consent.

 -  Male and female patients aged ≥12 years.

 -  A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.

 -  Evidence of airway reversibility or airway hyper- reactivity.

 -  FEV1 ≤80% of the predicted normal value for patients aged ≥18 years; FEV1 of ≤90% for
 patients aged 12 to <18 years

 -  An ACQ score ≥1.5

 -  A history of 2 or more asthma exacerbations within the 12 months prior to entering the
 study.

 Exclusion Criteria:

 -  Use of other investigational drugs within 5 half-lives of study entry, or within 30
 days, whichever is longer.

 -  Subjects who have participated in another trial of QAW039.

 -  A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).

 -  History of malignancy with the exception of local basal cell carcinoma of the skin.

 -  Pregnant or nursing (lactating) women.

 -  Serious co-morbidities.

 -  Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or
 >2 mg of pitavastatin.