Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03215758 | Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma | PHASE3 | COMPLETED | 675 | — | — | Nov 1, 2017 | Jul 30, 2019 | Jan 13, 2026 | 110 | United States, Argentina +8 |
| NCT03226392 | Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma | PHASE3 | COMPLETED | 704 | — | — | Oct 31, 2017 | Aug 1, 2019 | Jan 13, 2026 | 142 | United States, Brazil +16 |
| NCT02555683 | Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment. | PHASE3 | COMPLETED | 894 | — | — | Dec 11, 2015 | Nov 4, 2019 | May 18, 2020 | 233 | United States, Argentina +25 |
| NCT02563067 | Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment. | PHASE3 | COMPLETED | 877 | — | — | Dec 3, 2015 | Aug 2, 2019 | May 3, 2021 | 163 | United States, Argentina +17 |
| NCT01836471 | A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients | PHASE2 | COMPLETED | 345 | — | — | May 1, 2013 | Feb 1, 2016 | Mar 20, 2017 | 76 | United States, Belgium +8 |
| NCT01545726 | Safety and Efficacy of QAW039 in Sputum Eosinophilia and Persistent Asthma | PHASE2 | COMPLETED | 61 | — | — | Feb 1, 2012 | Jun 1, 2013 | Oct 9, 2013 | 1 | United Kingdom |
| NCT01437735 | Dose Finding Study for QAW039 in Asthma | PHASE2 | COMPLETED | 1,043 | — | — | Aug 1, 2011 | Nov 1, 2013 | Dec 19, 2020 | 206 | United States, Argentina +20 |
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.
A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours\*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours). The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.
A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours\*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours).
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug. Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF). Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug.
Sputum induction is performed through the inhalation of hypertonic saline. Sputum is collected and assessed for differential cellular content (absolute numbers and percentages). The primary variable will be summarized by treatment and analyzed using an ANCOVA model with treatment as the fixed effect and the respective baseline value as the covariate.
Forced Expiratory Volume in 1 second (FEV1) (measured in litters), and the trough measurement is taken 24 hours after morning dose on the previous day.
| Arm | Type | Description |
|---|---|---|
| QAW039 | ACTIVE_COMPARATOR | QAW039 once daily |
| Placebo | PLACEBO_COMPARATOR | Placebo once daily |
| QAW039 150 mg | EXPERIMENTAL | QAW039 150 mg once daily |
| QAW039 450 mg | EXPERIMENTAL | QAW039 450 mg once daily |
| QAW039 450 mg qd Non-atopic | EXPERIMENTAL | QAW039 450 mg (3 capsules of QAW039 150 mg) qd combined with background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1. |
| Placebo Non-atopic | PLACEBO_COMPARATOR | Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with background ICS (100 μg fluticasone, bid). Non-atopic randomized in ratio of approximately 1:1. |
| QAW039 450 mg qd Atopic | EXPERIMENTAL | QAW039 450 mg (3 capsules of QAW039 150 mg) qd combined with background ICS (100 μg fluticasone, bid). Atopic patients randomized in a ratio of approximate 1:1:1 |
| Fluticasone 150 mcg bid Atopic | ACTIVE_COMPARATOR | Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with 150 μg ICS and with background ICS (100 μg fluticasone, bid). As a consequence total ICS was 250 μg fluticasone bid. Atopic patients randomized in ratio of approximately 1:1:1 |
| Placebo Atopic | PLACEBO_COMPARATOR | Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with background ICS (100 μg fluticasone, bid). Atopic patients andomized in ratio of approximately 1:1:1 |
| QAW039 po dose 1 | EXPERIMENTAL | - |
| QAW039 po dose 2 | EXPERIMENTAL | - |
| QAW039 po dose 3 | EXPERIMENTAL | - |
| QAW039 po dose 4 | EXPERIMENTAL | - |
| QAW039 po dose 5 | EXPERIMENTAL | - |
| QAW039 po dose 6 | EXPERIMENTAL | - |
| QAW039 po dose 7 | EXPERIMENTAL | - |
| QAW039 po dose 8 | EXPERIMENTAL | - |
| QAW039 po dose 9 | EXPERIMENTAL | - |
| QAW039 po dose 10 | EXPERIMENTAL | - |
| QAW039 po dose 11 | EXPERIMENTAL | - |
| QAW039 po dose 12 | EXPERIMENTAL | - |
| QAW039 po dose 13 | EXPERIMENTAL | - |
| Montelukast po 10 mg | ACTIVE_COMPARATOR | Comparator leukotriene receptor antagonist (LRTA) |
| Name | Type | Description |
|---|---|---|
| QAW039 | DRUG | QAW039 once daily |
| Placebo | DRUG | Placebo once daily |
| Placebo QAW039 | DRUG | Matching placebo for QAW039 supplied as hard gelatin capsule were identical in appearance to their active counterparts. Patients took 3 QAW039 matching placebo capsules once a day ( taken with food in the morning) for the approximate period of the study (12 weeks) |
| Fluticasone 250 mcg | DRUG | Fluticasone was supplied in inhalers with dose strength of 250 mcg. Patients took 250 mcg bid (morning and evening approximately 12 hours between doses) for a total dose of 500 mcg daily for the approximate period of the study (12 weeks). |
| Fluticasone 100 mcg | DRUG | Background therapy - fluticasone was supplied in inhalers with dose strength of 100 mcg. All patients in the study other than the Atopic Fluticasone 150 mcg arm were given the 100 mcg dose strength inhalers and took fluticasone 100 mcg bid (taken morning and evening with approximately 12 hours between doses) as background therapy for the approximate period of the study (12 weeks). |
| Montelukast | DRUG | Montelukast 10 mg po |
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 m...