Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma

Inclusion Criteria:

- A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.

- Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose
ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor
antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1
and the doses have been stable for at least 4 weeks prior to Visit 1.

- FEV1 of ≤85% for patients aged ≥18 years. FEV1 of ≤90% for patients aged 12 to <18
years.

- Daytime asthma symptom score (0 to 6 scale) of ≥1 per day during 4 of the last 7 days
of the placebo run- in period.

- Total daily SABA use ≥1 puff per day during 4 of the last 7 days of the placebo run-in
period.

- Demonstrated reversible airway obstruction.

- Asthma control questionnaire (ACQ) score ≥ 1.5.

Exclusion Criteria:

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

- A resting QTcF (Fridericia) ≥450 msec (male) or

≥460 msec (female).

- 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.

Other protocol-defined inclusion/exclusion criteria may apply.