About this trial
This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to \<6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to \<6 years old with uncontrolled asthma and/or recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase.
Study details include:
Part A:
The study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period).
Part B:
For participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A \[4-week Screening and a 52-week treatment period\] plus additional 52-week treatment period and a 12-week post-treatment follow-up period).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Physician diagnosed Atopic Dermatitis,
Allergic sensitization to at least 1 aeroallergen (with a positive serum IgE defined as a value ≥0.35 kU/L).
Disqualifiers
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 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.
Trial design
Parallel
Treatments tested in this trial
Dupilumab
DrugPharmaceutical form: Injection solution Route of administration: Subcutaneous
Placebo
DrugPharmaceutical form: Injection solution Route of administration: Subcutaneous
Treatment groups
Trial outcomes
Primary outcomes
Part A: Annualized rate of severe asthma exacerbations during the 52-week treatment period
Annualized rate of severe asthma exacerbations during the 52-week treatment period.
Part B: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and AEs leading to permanent treatment discontinuation
Incidence of TEAEs, SAEs, AESIs, and AEs leading to permanent treatment discontinuation.
Secondary outcomes
Part A: Annualized rate of hospitalization, ER or urgent care visit for asthma exacerbation during the 52week treatment period.
Part A: Annualized rate of moderate asthma exacerbations during the 52-week treatment period
Annualized rate of moderate asthma exacerbations during the 52-week treatment period.
Part A: Cumulative ICS dose during the 52-week treatment period
Part A: Change from baseline in weekly average use of reliever medication during the 52-week treatment period
Sponsors and contacts
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Sanofi
Lead sponsor
Regeneron Pharmaceuticals
Collaborator