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

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations: * patient with inadequately controlled severe asthma and high eosinophil counts at baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population) * patients with inadequately controlled severe asthma (overall study population) Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).

Key facts

Study ID

NCT02555683

Run by

Novartis Pharmaceuticals

People needed

894

Starts

2015-12-11

Expected to finish

2019-11-04

Last updated by the study team

2020-05-18

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Birmingham, Alabama, United States
• Novartis Investigative Site — Gilbert, Arizona, United States
• Novartis Investigative Site — Litchfield Park, Arizona, United States
• Novartis Investigative Site — Peoria, Arizona, United States
• Novartis Investigative Site — Little Rock, Arkansas, United States
• Novartis Investigative Site — Hawaiian Gardens, California, United States
• Novartis Investigative Site — Newport Beach, California, United States
• Novartis Investigative Site — Redondo Beach, California, United States
• Novartis Investigative Site — Riverside, California, United States
• Novartis Investigative Site — Torrance, California, United States
• Novartis Investigative Site — Westminster, California, United States
• Novartis Investigative Site — New Haven, Connecticut, United States
• Novartis Investigative Site — Brandon, Florida, United States
• Novartis Investigative Site — New Smyrna Beach, Florida, United States
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — Ormond Beach, Florida, United States
• Novartis Investigative Site — Sebring, Florida, United States
• Novartis Investigative Site — Winter Park, Florida, United States
• Novartis Investigative Site — Gainesville, Georgia, United States
• Novartis Investigative Site — Marietta, Georgia, United States
• Novartis Investigative Site — Crowley, Louisiana, United States
• Novartis Investigative Site — Zachary, Louisiana, United States
• Novartis Investigative Site — Bangor, Maine, United States
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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