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

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.