Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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16 December 2019 |
Main ID: |
EUCTR2015-002553-35-FI |
Date of registration:
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10/12/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study of efficacy and safety of QAW039 in patients with severe asthma inadequately controlled with standard of care asthma treatment.
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Scientific title:
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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. |
Date of first enrolment:
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14/01/2016 |
Target sample size:
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846 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002553-35 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Austria
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Belgium
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Brazil
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China
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Denmark
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Estonia
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Finland
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France
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Germany
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Greece
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Guatemala
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Hungary
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Iceland
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Ireland
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Latvia
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Lithuania
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Luxembourg
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Philippines
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Poland
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Romania
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Singapore
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Spain
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Sweden
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Switzerland
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United Kingdom
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United States
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Vietnam
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Contacts
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Name:
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Medical Information Service
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Address:
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Metsänneidonkuja 10
02130
Espoo
Finland |
Telephone:
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Email:
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novartis.laakeinformaatio@novartis.com |
Affiliation:
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Novartis Finland Oy |
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Name:
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Medical Information Service
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Address:
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Metsänneidonkuja 10
02130
Espoo
Finland |
Telephone:
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Email:
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novartis.laakeinformaatio@novartis.com |
Affiliation:
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Novartis Finland Oy |
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Key inclusion & exclusion criteria
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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 <18 years, FEV1 of =90% of the predicted normal value for the patient, after withholding bronchodilators at Visit 1 and Visit 101.
-An ACQ score =1.5.
-A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.
Other inclusion criteria apply. See protocol for full details Are the trial subjects under 18? yes Number of subjects for this age range: 127 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 709 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
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
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Asthma
MedDRA version: 20.0
Level: PT
Classification code 10003553
Term: Asthma
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
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Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
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Intervention(s)
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Product Name: Fevipiprant Product Code: QAW039 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Fevipiprant CAS Number: 872365-14-5 Current Sponsor code: QAW039 Other descriptive name: QAW039-NXA.001 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Product Name: Fevipiprant Product Code: QAW039 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Fevipiprant CAS Number: 872365-14-5 Current Sponsor code: QAW039 Other descriptive name: QAW039-NXA.001 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 450- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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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.
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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).
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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), 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. To assess the safety of QAW039 (150 mg and 450 mg once daily), compared with placebo, with respect to adverse events, ECGs, vitals sign, laboratory tests and hypersensitivity reactions.
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Timepoint(s) of evaluation of this end point: 52 weeks
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Secondary Outcome(s)
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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.
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Timepoint(s) of evaluation of this end point: 52 weeks
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Secondary ID(s)
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2015-002553-35-GB
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CQAW039A2307
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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