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

• Register: EUCTR
• Last refreshed on: 26 September 2016
• Main ID: EUCTR2015-002553-35-IS
• Date of registration: 16/11/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Study of efficacy and safety of QAW039 in patients with severe asthma inadequately controlled with standard of care asthma treatment.
• Scientific title: 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: 29/12/2015
• Target sample size: 846
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002553-35
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Medicinsk Information
• Affiliation: Novartis Healthcare A/S

• Name: Medicinsk Information
• Affiliation: Novartis Healthcare A/S

Key inclusion & exclusion criteria

Inclusion criteria:
-Written informed consent.
-Male and female patients aged =12 years.
-A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.
-Evidence of airway reversibility or airway hyper-reactivity.
-FEV1 of =40% and =80% of the predicted normal value.
-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

Health Condition(s) or Problem(s) studied

Asthma
MedDRA version: 18.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

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

Primary Outcome(s)

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.

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

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.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 52 weeks

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.

Secondary ID(s)

2015-002553-35-GB

CQAW039A2307

Source(s) of Monetary Support

Novartis Pharma Services AG