Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)

Inclusion Criteria:

• Participant must be 2 to <6 years of age

• Diagnosis of asthma or recurrent severe asthmatic wheeze that is not controlled withchronic ICS for at least 3 months with stable use of at least low dose ICS for ≥1month prior to Screening Visit 1 with evidence of uncontrolled asthma and/orrecurrent severe asthmatic wheeze*.

• At least one additional major criterion from the modified asthma predictive index:

1. Physician diagnosed Atopic Dermatitis,

2. Allergic sensitization to at least 1 aeroallergen (with a positive serum IgEdefined as a value ≥0.35 kU/L).OR 2 minor criteria:

3. Wheezing unrelated to colds,

4. Peripheral blood eosinophilia ≥4%,

5. Allergic sensitization to milk, eggs, or peanuts (defined by serum specific IgE >0.35 kU/L.

• Parent(s)/caregiver(s)/legal guardian(s) willing and able to comply with clinicvisits and study-related procedures.

• Parent(s)/caregiver(s)/legal guardian(s) able to understand the study requirements.

• Participants/parent(s)/caregiver(s)/legal guardian(s), as appropriate, must be ableto understand and complete study-related questionnaires

• Body weight at screening and randomization >5 kg and <30 kg.

• Parents or caregivers or legal guardian capable of giving signed informed consent.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

• Severe asthma with the need for chronic oral/systemic corticosteroid use (>1 monthcontinuous) at the time of screening enrollment.

• History of a systemic hypersensitivity reaction or anaphylaxis to dupilumab or anyother biologic therapy, including any excipient.

• History of prematurity (<34 weeks gestation).

• Any other chronic lung disease that would impair lung function (eg, cystic fibrosis,bronchopulmonary dysplasia) or chronic lung disease of prematurity or need foroxygen for more than 5 days in the neonatal period.

• History of life-threatening asthma (eg, requiring intubation).

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