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

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  2 to 5

Participation Criteria

Inclusion Criteria:

* 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.

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 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.