Evaluation of Dupilumab in Children With Uncontrolled Asthma

The total study duration per patient will be up to 69 weeks, consisting of a screening period
of 3-5 weeks, a randomized treatment period of 52 weeks and a post-treatment period of 12
weeks.

Inclusion criteria :

Children 6 to <12 years of age, with a physician diagnosis of persistent asthma for ≥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 inhaled corticosteroids (ICS) with second
controller medication (ie, long-acting β2 agonist [LABA], leukotriene receptor
antagonist [LTRA], long acting muscarinic antagonist [LAMA], 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% of predicted
normal or pre bronchodilator FEV1/forced vital capacity (FVC) ratio <0.85 at Screening
and Baseline Visits.

- Reversibility of at least 10% in FEV1 after the administration of 200 to 400 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 are allowed with a
maximum of 12 puffs of reliever medication if tolerated by the patient).

- Must have experienced within 1 year prior to Screening Visit 1 any of the following
events:

- Treatment with a systemic corticosteroid (SCS, oral or parenteral), as prescribed
by a healthcare professional for worsening asthma at least once or,

- Hospitalization or emergency room 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 (ie, 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:

- Patients <6 or ≥12 years of age.

- Patients with <16 kg bodyweight.

- Any other chronic lung disease (cystic fibrosis, bronchopulmonary dysplasia, etc)
which may impair lung function.

- A subject 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 (IMP).

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.