Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.

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 and assent (if applicable).

- Male and female patients aged ≥12 years (or ≥lower age limit allowed by health
authority and/or ethics committee/institutional review board approvals).

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

- Evidence of airway reversibility or airway hyper- reactivity.

- FEV1 of ≤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 greater than 20 mg of simvastatin, greater than 40 mg of atorvastatin,
greater than 40 mg of pravastatin, or greater than 2 mg of pitavastatin