Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma
Condition: Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Intervention: Dupilumab; Placebo (for Dupilumab); Fluticasone/Salmeterol combination therapy; Fluticasone monotherapy; Albuterol; Levalbuterol
Intervention description: Solution for injection, one subcutaneous injection.; Solution for injection, one subcutaneous injection.; Oral inhalation twice daily.; Oral inhalation twice daily.; Oral inhalation as needed.; Oral inhalation as needed.
Intervention MeSH terms: Fluticasone; Xhance; Albuterol; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC)
      once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma
      exacerbation in participants with persistent moderate to severe eosinophilic asthma.

      Secondary Objectives:

        -  To assess the safety and tolerability of Dupilumab administered SC qw for 12 weeks in
           participants with persistent moderate to severe eosinophilic asthma.

        -  To assess Dupilumab serum concentrations following qw SC dosing for 12 weeks in
           participants with persistent moderate to severe eosinophilic asthma.
    

Eligibility criteria:

        Inclusion criteria:

        Medical diagnosis of persistent asthma for at least 12 months whose:

          -  airway inflammation likely to be eosinophilic,

          -  asthma partially controlled or uncontrolled on ICS plus LABA therapy.

          -  On a stable dose of either Fluticasone/Salmeterol, Budesonide/Formoterol,
             Mometasone/Formoterol combination therapy for at least 1 month prior to screening.

          -  Signed an Informed Consent Form and Health Insurance Portability and Accountability
             Act (HIPAA) Authorization Form.

        Exclusion criteria:

          -  Less than 18 years or greater than 65 years of age.

          -  Clinically relevant abnormal laboratory values suggesting an unknown disease and
             requiring further evaluation.

          -  Chronic obstructive pulmonary disease and/or other lung diseases impairing Pulmonary
             Function Tests.

          -  Beta-adrenergic receptor blockers required for any reason.

          -  Current smoker or cessation of smoking within the 6 months prior to screening.

          -  Previous smoking with a smoking history >10 cigarette pack/years.

          -  Participation in another study within 6 months prior to screening if the study
             medication was an antibody or within 30 days prior to screening for all other study
             medications.

          -  Known or suspected non-compliance, alcohol or drug abuse.

          -  Inability to follow the procedures of the study (e.g, due to language problems,
             psychological disorders).

          -  Concomitant severe diseases or diseases for which the use of ICS or LABA were
             contraindicated.

          -  Known allergy to doxycycline or related compounds.

          -  Pregnancy or intention to become pregnant during the course of the study, breast
             feeding, or unwillingness to use a highly effective method of contraception throughout
             the study in women of childbearing potential.

          -  Recent history of a parasitic infection or travel to a parasitic endemic area within 6
             months prior to screening.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.