Efficacy and Safety of Dupilumab in Children with Asthma/Asthmatic Wheeze
Phase 3
90
about 5 years
2–5
14 sites in AZ, FL, IL +7
What this study is about
Researchers are testing whether dupilumab, a medication, helps children aged 2 to <6 years with uncontrolled asthma or recurrent severe wheezing. The trial will last up to 1814 days. Participants will be given either dupilumab or a placebo.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Dupilumab
- 2.Take Placebo
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
dupilumab
Primary: 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
Secondary: Part A: Annualized rate of hospitalization, ER or urgent care visit for asthma exacerbation during the 52week treatment period., Part A: Change from baseline in blood eosinophil level at Weeks 24 and 52, Part A: Change from baseline in weekly average use of reliever medication during the 52-week treatment period, 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 Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Scale, 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)
Respiratory