Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma; Inflammation
Intervention: Placebo; Dupilumab SAR231893/REGN668; fluticasone propionate and salmeterol; budesonide and formoterol; mometasone furoate and formoterol
Intervention description: Pharmaceutical form:solution Route of administration: subcutaneous; Pharmaceutical form:solution Route of administration: subcutaneous; Pharmaceutical form:inhalation aerosol, inhalation powder Route of administration: inhaled; Pharmaceutical form:inhalation aerosol Route of administration: inhaled; Pharmaceutical form:inhalation aerosol Route of administration: inhaled
Intervention MeSH terms: Fluticasone; Xhance; Mometasone Furoate; Budesonide; Formoterol Fumarate; Salmeterol Xinafoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.