Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest)
Condition: Asthma
MeSH terms: Asthma
Intervention: Dupilumab; Placebo; Inhaled corticosteroid (ICS) therapy; Albuterol/Salbutamol; Levalbuterol/Levosalbutamol
Intervention description: Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.; Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.; Oral inhalation, stable dose (medium or high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy); Oral inhalation as needed; Oral inhalation as needed
Intervention MeSH terms: Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1902.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent
      asthma.

      Secondary Objectives:

        -  To evaluate the safety and tolerability of dupilumab.

        -  To evaluate the effect of dupilumab on improving participant-reported outcomes including
           health-related quality of life.

        -  To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.
    

Eligibility criteria:

        Inclusion criteria:

        -Adults and adolescent participants with a physician diagnosis of asthma for ≥12 months,
        based on the Global Initiative for Asthma (GINA) 2014 Guidelines and the following
        criteria:

        a) Existing treatment with medium to high dose ICS (≥250 mcg of fluticasone propionate
        twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone
        propionate or equivalent) in combination with a second controller (eg, long-acting beta
        agonist, leukotriene receptor antagonist) for at least 3 months with a stable dose ≥1 month
        prior to Visit 1.

        i) Note for Japan: for participants aged 18 years and older, ICS must be on ≥200 mcg of
        fluticasone propionate twice daily or equivalent; for participants aged 12 to 17 years, ICS
        must be ≥100 mcg of fluticasone propionate twice daily or equivalent).

        ii) Participants requiring a third controller for their asthma will be considered eligible
        for this study, and it should also be used for at least 3 months with a stable dose ≥1
        month prior to Visit 1.

        Exclusion criteria:

          -  Participants <12 years of age or the minimum legal age for adolescents in the country
             of the investigative site, whichever is higher (For those countries where local
             regulations permit enrollment of adults only, participant recruitment will be
             restricted to those who are ≥18 years of age).

          -  Weight is less than 30 kilograms.

          -  Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary
             fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function.

          -  A participant who experiences a severe asthma exacerbation (defined as a deterioration
             of asthma that results in emergency treatment, hospitalization due to asthma, or
             treatment with systemic steroids at any time from 1 month prior to the Screening Visit
             up to and including the Baseline Visit).

          -  Evidence of lung disease(s) other than asthma, either clinical evidence or imaging
             (Chest X-ray, CT, MRI) within 12 months of Visit 1 or at the screening visit, as per
             local standard of care.

          -  Note for Japan: According to the request from the health authority, chest X-ray should
             be performed at screening visit if there is no chest imaging (Chest X-ray, computed
             tomography [CT], magnetic resonance imaging [MRI]) available within 3 months prior to
             screening to exclude participants with suspected active or untreated latent
             tuberculosis.

          -  Current smoker or cessation of smoking within 6 months prior to Visit 1.

          -  Previous smoker with a smoking history >10 pack-years.

          -  Comorbid disease that might interfere with the evaluation of Investigational Medicinal
             Product.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.