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

An Exploratory, Double-blind, Placebo-controlled Study of the Effects of Dupilumab on Airway Inflammation of Adults With Persistent 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.