Study of efficacy and safety of QAW039 when added to standard-of-care asthma therapy in patients with uncontrolled asthma

• Register: EUCTR
• Last refreshed on: 1 February 2020
• Main ID: EUCTR2017-001273-16-DE
• Date of registration: 09/08/2017
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: Study of efficacy and safety of QAW039 when added to standard-of-care asthma therapy in patients with uncontrolled asthma
• Scientific title: A 12-week, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of QAW039 when added to standard-of-care asthma therapy in patients with uncontrolled asthma - ZEAL
• Target sample size: 650
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001273-16
• 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: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Germany, Hungary, Kuwait, Mexico, Philippines, Saudi Arabia, Slovakia, South Africa, Turkey, United States

Contacts

• Name: Medizinischer Infoservice (MCC)
• Affiliation: Novartis Pharma GmbH

• Name: Medizinischer Infoservice (MCC)
• Affiliation: Novartis Pharma GmbH

Key inclusion & exclusion criteria

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 medium dose ICS plus LABA for at least 3 months prior to Visit 1 and the doses have been stable for at least 4 weeks prior to Visit 1.
-FEV1 of =85% for patients aged =18 years. FEV1 of =90% for patients aged 12 to <18 years.
-Daytime asthma symptom score (0 to 6 scale) of =1 per day during 4 of the last 7 days of the placebo run-in period.
-Total daily SABA use =1 puff per day during 4 of the last 7 days of the placebo run-in period.
-Demonstrated reversible airway obstruction.
-Asthma control questionnaire (ACQ) score = 1.5.
Are the trial subjects under 18? yes
Number of subjects for this age range: 65
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 455
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

Exclusion criteria:
-Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
-A resting QTcF (Fridericia) =450 msec (male) or =460 msec (female).
-Pregnant or nursing (lactating) women.
-Serious co-morbidities.
-Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

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

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

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Objective: 1. To demonstrate the efficacy of QAW039 150 mg once daily, compared with placebo, on daytime asthma symptoms over the 12-week active-treatment period.
2. To demonstrate the efficacy of QAW039 150 mg once daily, compared with placebo, on total daily short-acting ß-agonist (SABA) use over the 12-week active-treatment period.
3. To demonstrate the efficacy of QAW039 150 mg once daily, compared with placebo, on change from baseline in Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) scores at the end of the
12-week active-treatment period.
4. To assess the safety of QAW039 150 mg once daily, compared with placebo, with respect to adverse events (AEs), electrocardiograms (ECGs), vital signs and laboratory tests.

Main Objective: To demonstrate the efficacy of QAW039 150 mg once daily as measured by change from baseline in pre-dose FEV1 [in liters], compared with placebo, at the end of the 12-week active-treatment period.

Primary end point(s): -Pre-dose Forced Expiratory Volume in 1 second (FEV1) (L)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 12 weeks

Secondary end point(s): - Daytime asthma symptom score
- Short-acting beta agonist (SABA) taken per day
- Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) score

Secondary ID(s)

CQAW039A2316

Source(s) of Monetary Support

Novartis Pharma AG