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

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

 Secondary Objective:

 To evaluate different doses and regimens of dupilumab in participants 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:

 Participants 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

 -  Asthma Control Questionnaire, 5-question version (ACQ-5) score >=1.5

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

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

 Exclusion criteria:

 -  Participants <18 years

 -  Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, emphysema,
 idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary
 aspergillosis) which impaired 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 was not intended to contain all considerations relevant to a
 participant's potential participation in a clinical trial.