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 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.