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



Status:Active, not recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:1/19/2019
Start Date:December 11, 2015
End Date:December 20, 2019

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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.

This study aims to determine the efficacy and safety of QAW039 (Dose 1 and Dose 2), compared
with placebo, when added to GINA steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA
2015) in each of the groups (patients with severe asthma and high eosinophil counts and all
patients with severe asthma).

A double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses
(Dose 1 and Dose 2) of QAW039 compared with placebo over a 52-week treatment period in in
each of the groups (patients with severe asthma and high eosinophil counts and all patients
with severe asthma). Efficacy will be measured by the rate of asthma exacerbations. In
addition, asthma quality of life score, asthma control score and lung function will be
assessed. Safety will be assessed by adverse event monitoring.

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
We found this trial at
53
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Peoria, Arizona 85381
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Bangor, Maine 04401
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Bellevue, Nebraska 68123
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Birmingham, Alabama 35209
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Boerne, Texas 78006
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Brandon, Florida 33511
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Caba, Buenos Aires
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Canton, Ohio 44718
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Charlotte, North Carolina 28277
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Cincinnati, Ohio 45229
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Corning, New York 14830
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Crowley, Louisiana 70526
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East Providence, Rhode Island 02914
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Fairfax, Virginia 22031
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Gainesville, Georgia 30501
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Gaithersburg, Maryland 20878
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Gastonia, North Carolina 28054
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Gilbert, Arizona 85234
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Hawaiian Gardens, California 90716
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Jefferson Hills, Pennsylvania 15025
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Lincoln, Nebraska 68506
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Litchfield Park, Arizona 85340
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Little Rock, Arkansas 72204
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Livonia, Michigan 48152
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Marietta, Georgia 30060
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Maumee, Ohio 43537
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McKinney, Texas 75069
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Monroe, North Carolina 28112
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New Bern, North Carolina 28562
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New Haven, Connecticut
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New Smyrna Beach, Florida 32168
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Newport Beach, California 92663
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Oklahoma City, Oklahoma 73104
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Omaha, Nebraska 68144
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Orlando, Florida 32806
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Ormond Beach, Florida 32174
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Picayune, Mississippi 39466
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Pittsburgh, Pennsylvania 15224
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Plano, Texas 75024
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Redondo Beach, California 90277
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Riverside, California 92506
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San Antonio, Texas 78207
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Sebring, Florida 33870
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Torrance, California 90502
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Waldorf, Maryland 20602
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Westminster, California 92683
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Whiteville, North Carolina 28472
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Wilmington, North Carolina 28401
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Winston-Salem, North Carolina 27157
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Winter Park, Florida 32789
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Ypsilanti, Michigan 48197
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Zachary, Louisiana 70791
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