Vanderbilt Clinical Trials

• Participant must be 2 to <6 years of age - Diagnosis of asthma or recurrent severe asthmatic wheeze that is not controlled with chronic ICS for at least 3 months with stable use of at least low dose ICS for ≥1 month prior to Screening Visit 1 with evidence of uncontrolled asthma and/or recurrent 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 IgE defined 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 clinic visits 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 able to 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.

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 month continuous) at the time of screening enrollment. - History of a systemic hypersensitivity reaction or anaphylaxis to dupilumab or any other 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 for oxygen 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.