Study of efficacy and safety of QAW039 in patients with severe asthma inadequately controlled with standard of care asthma treatment.

A 52-week, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of QAW039 when added to existing asthma therapy in patients with uncontrolled severe asthma.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002553-35-GB

Enrollment

846

Registered

2015-09-01

Start date

2016-02-20

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: Fevipiprant Product Code: QAW039 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Fevipiprant CAS Number: 8723

Eligibility

Sex/Gender

All

Inclusion 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. -For patients aged =18 years, FEV1 of =80% of the predicted normal value for the patient, after withholding bronchodilators at Visit 1 and Visit 101. For patients aged 12 to =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

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, and >2 mg of pitavastatin Other exclusion criteria apply. See protocol for full details

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Reduction in the rate of moderate-to-severe asthma exacerbations. 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).;Timepoint(s) of evaluation of this end point: 52 weeks; Main Objective: In patients with severe asthma and high eosinophil counts (=250 cells/µl) receiving SoC asthma therapy, to demonstrate the efficacy (as measured by rate of moderate-to-severe asthma exacerbations) of at least one dose level of QAW039 (150 mg or 450 mg once daily), compared with placebo, at the end of the 52-week active-treatment epoch. In patients with severe asthma receiving SoC asthma therapy, to demonstrate the efficacy (as measured by rate of moderate-to-severe asthma exacerbations) of at least one dose level of QAW039 (150 mg or 450 mg once daily), compared with placebo, at the end of the 52-week active-treatment epoch. ; Secondary Objective: In patients with severe asthma and high eosinophil counts (=250 cells/µl) receiving SoC asthma therapy to demonstrate the efficacy of at least one dose level of QAW039 (150 mg or 450 mg once daily), compared with placebo, with respect to change from baseline, at the end of the 52-week active-treatment epoch, in AQLQ+12 scores, ACQ-5 score and pre-dose FEV1. In all patients with severe asthma receiving SoC asthma therapy to demonstrate the efficacy of at least one dose level of QAW039 (150 mg or 450 mg once daily), compa	—

Measure

Time frame

Primary end point(s): Reduction in the rate of moderate-to-severe asthma exacerbations. 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).;Timepoint(s) of evaluation of this end point: 52 weeks; Main Objective: In patients with severe asthma and high eosinophil counts (=250 cells/µl) receiving SoC asthma therapy, to demonstrate the efficacy (as measured by rate of moderate-to-severe asthma exacerbations) of at least one dose level of QAW039 (150 mg or 450 mg once daily), compared with placebo, at the end of the 52-week active-treatment epoch. In patients with severe asthma receiving SoC asthma therapy, to demonstrate the efficacy (as measured by rate of moderate-to-severe asthma exacerbations) of at least one dose level of QAW039 (150 mg or 450 mg once daily), compared with placebo, at the end of the 52-week active-treatment epoch. ; Secondary Objective: In patients with severe asthma and high eosinophil counts (=250 cells/µl) receiving SoC asthma therapy to demonstrate the efficacy of at least one dose level of QAW039 (150 mg or 450 mg once daily), compared with placebo, with respect to change from baseline, at the end of the 52-week active-treatment epoch, in AQLQ+12 scores, ACQ-5 score and pre-dose FEV1. In all patients with severe asthma receiving SoC asthma therapy to demonstrate the efficacy of at least one dose level of QAW039 (150 mg or 450 mg once daily), compa

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Secondary

Measure	Time frame
Secondary end point(s): - Change from baseline in AQLQ+12 score. AQLQ+12 consists of 32 questions each scaled from 1 to 7, where 1 indicates maximal impairment and 7 indicates no impairment. - Change from baseline in ACQ-5 score. The ACQ- 5 consists of 5 questions on a 7-point scale (0=no impairment, 6=maximum impairment). - Change from baseline in pre-dose FEV1 (liters). - Adverse event monitoring. ;Timepoint(s) of evaluation of this end point: 52 weeks	—

Measure

Time frame

Secondary end point(s): - Change from baseline in AQLQ+12 score. AQLQ+12 consists of 32 questions each scaled from 1 to 7, where 1 indicates maximal impairment and 7 indicates no impairment. - Change from baseline in ACQ-5 score. The ACQ- 5 consists of 5 questions on a 7-point scale (0=no impairment, 6=maximum impairment). - Change from baseline in pre-dose FEV1 (liters). - Adverse event monitoring. ;Timepoint(s) of evaluation of this end point: 52 weeks

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Countries

Australia, Austria, Belgium, Brazil, China, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Philippines, Poland, Romania, Singapore, Spain, Sweden, Switzerland, United Kingdom, United States, Vietnam

Contacts

Public ContactMedical Collaboration Centre

Novartis Pharmaceuticals UK Ltd

medinfo.uk@novartis.com+441276698370

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026