Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02555683
• Date of registration: 18/09/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• 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: December 11, 2015
• Target sample size: 894
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02555683
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis

Key inclusion & exclusion 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.

- FEV1 of =80% of the predicted normal value for patients aged =18 years; FEV1 of =90%
for patients aged 12 to <18 years

- An ACQ score =1.5.

- A history of 2 or more asthma exacerbations within the 12 months prior to entering the
study.

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 greater than 20 mg of simvastatin, greater than 40 mg of atorvastatin,
greater than 40 mg of pravastatin, or greater than 2 mg of pitavastatin



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: Placebo

Drug: QAW039

Primary Outcome(s)

Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation [Time Frame: Baseline, Week 52]

Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in Overall Population [Time Frame: Baseline, Week 52]

Secondary Outcome(s)

Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in Overall Population [Time Frame: Baseline, Week 52]

Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in High Eosinophils Subpopulation [Time Frame: 52 weeks]

Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in Overall Population [Time Frame: Baseline, Week 52]

Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in High Eosinophils Subpopulation [Time Frame: Baseline, Week 52]

Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation [Time Frame: Baseline, Week 52]

Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in Overall Population [Time Frame: Baseline, Week 52]

Secondary ID(s)

2015-002553-35

CQAW039A2307

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/05/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02555683