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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03052517




Registration number
NCT03052517
Ethics application status
Date submitted
23/01/2017
Date registered
14/02/2017
Date last updated
12/10/2020

Titles & IDs
Public title
Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment
Scientific title
A 2-treatment Period, Randomized, Placebo-controlled, Multicenter Parallel-group Study to Assess the Safety of QAW039 When Added to Existing Asthma Therapy in GINA Steps 3, 4 and 5 Patients With Uncontrolled Asthma.
Secondary ID [1] 0 0
2016-001560-11
Secondary ID [2] 0 0
CQAW039A2315
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - QAW039 150 mg
Treatment: Drugs - QAW039 450 mg
Treatment: Drugs - Placebo

Experimental: QAW039 150mg - QAW039 Dose 1 once daily

Experimental: QAW039 450 mg - QAW039 Dose 2 once daily

Placebo Comparator: Placebo - Placebo once daily


Treatment: Drugs: QAW039 150 mg
One tablet of QAW039 150 mg once daily

Treatment: Drugs: QAW039 450 mg
One tablet of QAW039 450 mg once daily

Treatment: Drugs: Placebo
One tablet of Placebo once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model
Timepoint [1] 0 0
52 weeks
Primary outcome [2] 0 0
Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model
Timepoint [2] 0 0
156 weeks
Primary outcome [3] 0 0
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model
Timepoint [3] 0 0
52 weeks
Primary outcome [4] 0 0
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 156 - Cox Regression Model
Timepoint [4] 0 0
156 weeks
Primary outcome [5] 0 0
Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 52 - Cox Regression Model
Timepoint [5] 0 0
52 weeks
Primary outcome [6] 0 0
Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 156 - Cox Regression Model
Timepoint [6] 0 0
156 weeks
Secondary outcome [1] 0 0
Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model
Timepoint [1] 0 0
52 weeks
Secondary outcome [2] 0 0
Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model
Timepoint [2] 0 0
156 weeks
Secondary outcome [3] 0 0
Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 52
Timepoint [3] 0 0
52 weeks
Secondary outcome [4] 0 0
Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 156
Timepoint [4] 0 0
156 weeks
Secondary outcome [5] 0 0
Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 52
Timepoint [5] 0 0
52 weeks
Secondary outcome [6] 0 0
Rate of Treatment Emergent Severe Asthma Exacerbation Episodes Requiring Hospitalizations Per Person Year up to Week 156
Timepoint [6] 0 0
156 weeks

Eligibility
Key inclusion criteria
Patients completing a prior Phase 3 study of QAW039:

- Informed consent and assent (if applicable).

- Completion of the Treatment Period (on blinded study drug) of a prior Phase 3 study of
QAW039.

- Patient is able to safely continue into the study as judged by the investigator.

Patients who have not previously participated in a study of QAW039:

- Written informed consent.

- A diagnosis of asthma,uncontrolled on GINA 3/4/5 asthma medication.

- Evidence of airway reversibility or airway hyper- reactivity.

- FEV1 of =85% of the predicted normal value.

- An ACQ score =1.5 prior to entering the study.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients completing a prior phase 3 study of QAW039:

- Pregnant or nursing (lactating) women.

- Women of child-bearing potential unless they are using basic methods of contraception
during dosing of study drug

- Patients who did not complete the Treatment Period on blinded study drug of the prior
QAW039 study they participated in.

- Inability to comply with all study requirements.

- Patient who experienced a serious and drug-related AE in the prior QAW039 study they
participated in.

Patients who have not previously participated in a study of QAW039:

- 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 (i.e.-the patient was
randomized in another study).

- 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 greater than 20 mg of simvastatin> 40 mg of atorvastatin, >40 mg of
pravastatin, or >2 mg of pitavastatin. Statin doses less than or equal to these doses
as well as other statins will be permitted during the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/03/2020
Sample size
Target
Accrual to date
Final
2538
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Clayton
Recruitment hospital [2] 0 0
Novartis Investigative Site - Footscray
Recruitment hospital [3] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3011 - Footscray
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
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United States of America
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Madrid
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Country [216] 0 0
Spain
State/province [216] 0 0
Zaragoza
Country [217] 0 0
Switzerland
State/province [217] 0 0
Liestal
Country [218] 0 0
Switzerland
State/province [218] 0 0
Lugano
Country [219] 0 0
Taiwan
State/province [219] 0 0
Taichung
Country [220] 0 0
Turkey
State/province [220] 0 0
TUR
Country [221] 0 0
Turkey
State/province [221] 0 0
Adana
Country [222] 0 0
Turkey
State/province [222] 0 0
Ankara
Country [223] 0 0
Turkey
State/province [223] 0 0
Bursa
Country [224] 0 0
Turkey
State/province [224] 0 0
Mersin
Country [225] 0 0
Turkey
State/province [225] 0 0
Yenisehir/Izmir
Country [226] 0 0
United Kingdom
State/province [226] 0 0
Cambrigdeshire
Country [227] 0 0
United Kingdom
State/province [227] 0 0
Devon
Country [228] 0 0
United Kingdom
State/province [228] 0 0
Surrey
Country [229] 0 0
United Kingdom
State/province [229] 0 0
West Yorkshire
Country [230] 0 0
United Kingdom
State/province [230] 0 0
East Yorkshire
Country [231] 0 0
United Kingdom
State/province [231] 0 0
Leicester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study was a 2-treatment period, randomized, multicenter parallel-group study. The
overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039)
(Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma
(GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with
moderate-to- severe asthma.

The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily
and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5
standard-of-care asthma therapy (GINA 2020) in adult and adolescent (=12 years) patients with
moderate-to-severe asthma. The study included 2 cohorts of patients:

1. Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies
with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred
to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration
of exposure, and

2. New patients who had not previously participated in a study of QAW039, permitting an
increase in the number of patients with long-term exposure to QAW039.

By including these 2 categories of patients, the total number of patients treated with QAW039
as well as the duration of exposure to QAW039 treatment was substantially increased,
supporting evaluation of the safety profile of QAW039.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03052517
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03052517