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

 To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in
 participants with persistent asthma.

 Secondary Objective:

 To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.
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.