An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2013
End Date:April 2015

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A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

Primary Objective:

To evaluate the efficacy of different doses and regimens of dupilumab in patients with
moderate to severe uncontrolled asthma

Secondary Objective:

To evaluate different doses and regimens of dupilumab in patients with moderate to severe
uncontrolled asthma, with regard to:

- Safety and tolerability

- Dupilumab systemic exposure and anti-drug antibodies

Total duration per participant of approximately 43 weeks including a screening period (14-21
days) , a randomized treatment period (24 weeks), and a post-treatment period (16 weeks).

Inclusion criteria:

Patients with a physician diagnosis of moderate to severe, uncontrolled asthma for ≥12
months, based on the Global Initiative for Asthma (GINA) 2009 Guidelines and:

- Existing treatment with moderate- or high-dose inhaled corticosteroid / long-acting
beta-2 agonist

- Forced expiratory volume (FEV1) 40 to 80% of predicted normal

- Juniper Asthma Control Questionnaire, 5-question version (ACQ-5) score ≥1.5

- Reversibility of at least 12% and 200 mL in forced expiratory volume (FEV1)

- Has experienced, within prior year: hospitalization, emergency or urgent care visit
or systemic corticosteroid treatment for worsening asthma

Exclusion criteria:

- Patients <18 years

- Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, emphysema,
idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary
aspergillosis) which impair pulmonary function tests

- Chest X-ray within 12 months of screening visit or at screening visit with clinically
significant findings of lung disease(s) other than asthma

- Current smoker or cessation of smoking within 6 months prior to Visit 1

- Previous smoker with a smoking history >10 pack-years

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
We found this trial at
52
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Mission Viejo, California 92691
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Baltimore, MD
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Buenos Aires,
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Colorado Springs, Colorado 80910
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Colorado Springs, Colorado 80910
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Dallas, TX
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El Paso, TX
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Evansville, IN
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Everett, WA
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Fullerton, CA
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Huntington Beach, California 92646
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Lake Oswego, OR
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Los Angeles, CA
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Los Angeles, CA
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Louisville, KY
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Medford, OR
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Miami, FL
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Minneapolis, MN
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Missoula, MT
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Newport Beach, California 92660
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North Dartmouth, Massachusetts 02747
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Novi, MI
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Oklahoma City, OK
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Papillion, NE
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Philadelphia, PA
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Princeton, NJ
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Richmond, VA
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Rolling Hills Estates, California 90274
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San Antonio, TX
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Spartanburg, South Carolina 29303
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Wheaton, MD
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