Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma

The total study duration for each participant was between approximately 29 and maximum of 30
weeks, consisting of a screening period of 5 weeks and optional up to 7 additional days, a
treatment period of 12 weeks, and a post-treatment period of 12 weeks.

Participants who completed the treatment period could be eligible to participate in an
open-label extension study.

Inclusion criteria:

- Male and female adults with a physician diagnosis of persistent asthma for ≥12 months.

- Existing treatment with medium to high dose inhaled corticosteroids in combination
with a long-acting beta agonist for at least 3 months with a stable dose ≥1 month
prior to Visit 1 (Screening Visit).

- Treatment with a third asthma controller for at least 3 months with a stable dose >=1
month prior to Visit 1 was allowed.

- Pre-bronchodilator forced expiratory volume (FEV1) 55 to 85% of predicted normal.

Exclusion criteria:

- Participants <18 years or >65 years.

- Fractional exhaled nitric oxide (FeNO) <26 parts per billion (ppb) at Visit 1
(Screening Visit).

- Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary
fibrosis, eosinophilic granulomatosis with polyangiitis [Churg-Strauss Syndrome])
which could impair lung function.

- A participant who experienced an asthma exacerbation that resulted in emergency
treatment, hospitalization due to asthma, or treatment with systemic steroids at any
time from 1 month prior to Visit 1.

- A participant who had experienced an upper or lower respiratory tract infection within
the 4 weeks prior to Visit 1.

- Evidence of lung disease(s) other than asthma.

- Previous smoker (smoking history >10 pack-years) or current smoker (within 6 months
prior to Visit 1).

- Comorbid disease that might interfere with the evaluation of investigational medicinal
product or conduct of study procedures (e.g., bronchoscopy).

- Anti-immunoglobulin E (IgE) therapy (omalizumab) or any other biologic therapy within
6 months of Visit 1.

- Exposure to another investigative study medication within a time period prior to Visit
1 that is less than 5 half-lives of the study medication.

- Treatment with systemic (oral or injectable) corticosteroids within 28 days of Visit
1.

The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.