A randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and long-term safety of dupilumab in children 2 to <6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze

Respiratory tract diseases - Wheezing, Asthma

Part A: 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

Part A: Annualized rate of hospitalization, ER or urgent care visit for asthma exacerbation during the 52 week treatment period., Part A: 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, Part A: Mean number of days without asthma symptoms (DWAS) using the Pediatric Asthma Caregiver Diary (PACD) during the 52-week treatment period, Part A: Change from baseline to Week 52 in daytime symptom score using the daytime record of PACD, Part A: Incidence of TEAEs, SAEs, AESIs, and AEs leading to permanent treatment discontinuation, Part A: Change from baseline to Week 52 in Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Scale, Part A: Caregiver Global Impression of Change in their child’s asthma control (CGI-change in asthma control) at Week 52, Part A: Physician Global Assessment of Change of the child’s asthma control (PGA-change in asthma control) at Week 52, Part A: Change from baseline to Week 52 in Caregiver Global Impression of their child’s asthma control (CGI-asthma control), Part A: Change from baseline to Week 52 in Caregiver Global Impression of their child’s asthma severity (CGI-asthma severity), Part A: Change from baseline to Week 52 in Physician Global Assessment of the child’s asthma control (PGA-asthma control)., Part A: Change from baseline to Week 52 in Test for Respiratory and Asthma Control in Kids (TRACK), Part A: Change from baseline in blood eosinophil level at Weeks 24 and 52, Part A: Concentration of dupilumab in serum over time during the 52-week treatment period, Part A: Incidence of treatment-emergent anti-drug antibody (ADA) against dupilumab over time, Part A: IgG response to any vaccination for tetanus, diphtheria and pertussis and antibody for influenza (HAI antibody titers) vaccine administered according to vaccination schedule during the 52-week treatment period, Part B: Annualized rate of severe asthma exacerbations events during the 52-week Part B treatment period, Part B Concentration of dupilumab in serum over time during the 52-week Part B treatment period, Part B: Incidence of treatment-emergent anti-drug antibodies (ADAs) against dupilumab over time

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