Evaluation of Dupilumab in Children With Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Dupilumab; Placebo; Asthma Controller Therapies; Asthma Reliever Therapies
Intervention description: Pharmaceutical form: Solution
Route of administration: Subcutaneous; Pharmaceutical form: Solution
Route of administration: Subcutaneous; Pharmaceutical form: Aerosol, capsules, tablets, oral solution
Route of administration: Inhaled, oral; Pharmaceutical form: Nebulized, aerosol
Route of administration: Inhaled
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 408.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To evaluate the efficacy of dupilumab in children 6 to less than (<) 12 years of age with
      uncontrolled persistent asthma.

      Secondary Objective:

      To evaluate in children 6 to <12 years of age with uncontrolled persistent asthma:

        -  The safety and tolerability of dupilumab.

        -  The evaluate the effect of dupilumab in improving participant reported outcomes
           including health related quality of life.

        -  The dupilumab systemic exposure and incidence of anti-drug antibodies.

        -  The evaluate the association between dupilumab treatment and pediatric immune responses
           to vaccines: any vaccination for tetanus, diphtheria, pertussis and/or seasonal
           trivalent/quadrivalent influenza vaccine.
    

Eligibility criteria:

        Inclusion criteria :

        Children 6 to <12 years of age, with a physician diagnosis of persistent asthma for greater
        than or equal to (>=)12 months prior to screening, based on clinical history and
        examination, pulmonary function parameters according to Global initiative for asthma (GINA)
        2015 Guidelines and the following criteria:

          -  Existing background therapy of medium-dose ICS with second controller medication
             (i.e., long-acting β2 agonist , leukotriene receptor antagonist, long acting
             muscarinic antagonist, or methylxanthines) or high-dose ICS alone or high-dose ICS
             with second controller, for at least 3 months with a stable dose >=1 month prior to
             Screening Visit 1.

          -  Pre-bronchodilator forced expiratory volume in 1 second (FEV1) <=95 percentage (%) of
             predicted normal or pre bronchodilator FEV1/forced vital capacity ratio <0.85 at
             Screening and Baseline Visits.

          -  Reversibility of at least 10% in FEV1 after the administration of 200 to 400
             micrograms (mcg; 2 to 4 puff inhalations with metered-dose inhaler [MDI]) of
             albuterol/salbutamol or 45 to 90 mcg (2 to 4 puffs with MDI) of
             levalbuterol/levosalbutamol reliever medication before randomization (up to 3
             opportunities during the same visit were allowed with a maximum of 12 puffs of
             reliever medication if tolerated by the participant).

          -  Must had experienced, within 1 year prior to Screening Visit 1, any of the following
             events:

               -  Treatment with a systemic corticosteroid (oral or parenteral), as prescribed by a
                  healthcare professional for worsening asthma at least once or,

               -  Hospitalization or emergency visit for worsening asthma.

          -  Evidence of uncontrolled asthma, with at least one of the following criteria during
             the 4 (±1) weeks Screening Period:

               -  Asthma Control Questionnaire-Interviewer Administered (ACQ-IA) ACQ-5 score >=1.5
                  on at least one day of the Screening Period.

               -  Use of reliever medication (i.e., albuterol/salbutamol or
                  levalbuterol/levosalbutamol), other than as a preventive for exercise induced
                  bronchospasm, on 3 or more days per week, in at least one week during the
                  Screening Period.

               -  Sleep awakening due to asthma symptoms requiring use of reliever medication at
                  least once during the Screening Period.

               -  Asthma symptoms 3 or more days per week in at least one week during the Screening
                  Period.

        Exclusion criteria:

          -  Participants <6 or >=12 years of age.

          -  Participants with <16 kg bodyweight.

          -  Any other chronic lung disease (cystic fibrosis, bronchopulmonary dysplasia, etc.),
             which may impair lung function.

          -  A participant with any history of life threatening asthma (ie, extreme exacerbation
             that requires intubation).

          -  Co-morbid disease that might interfere with the evaluation of investigational
             medicinal product.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.