Phase 3 N=894 Randomized Double-blind Treatment

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

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT02555683 ↗

Enrolled (actual)

894

Serious AEs

10.7%

Results posted

May 2020

Primary outcome: Primary: Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation — 0.97; 0.77; 0.93 events/year — p=0.800

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: QAW039 (Drug); Placebo (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Oct 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation	0.97; 0.77; 0.93	0.800
PRIMARY Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in Overall Population	0.92; 0.75; 0.96	0.819
SECONDARY Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in High Eosinophils Subpopulation	0.75; 0.81; 0.68	0.819
SECONDARY Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in High Eosinophils Subpopulation	-0.88; -0.94; -0.76	0.819
SECONDARY Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation	0.169; 0.153; 0.103	0.800
SECONDARY Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in Overall Population	0.68; 0.73; 0.61	0.819
SECONDARY Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in Overall Population	-0.83; -0.90; -0.71	0.819
SECONDARY Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in Overall Population	0.144; 0.108; 0.068	0.819

Summary

This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations: * patient with inadequately controlled severe asthma and high eosinophil counts at baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population) * patients with inadequately controlled severe asthma (overall study population) Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02555683). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.