At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Children 6 to <12 Years of Age With Uncontrolled Persistent Asthma
In Brief
A Phase 3 clinical trial evaluating Dupilumab, Placebo, and 2 other interventions for Asthma. Completed, enrolled 408 participants across 99 sites in 18 countries.
Detailed Summary
Primary Objective: To evaluate the efficacy of dupilumab in children 6 to less than (\<) 12 years of age with uncontrolled persistent asthma. Secondary Objective: To evaluate in children 6 to \<12 years of age with uncontrolled persistent asthma: * The safety and tolerability of dupilumab. * The evaluate the effect of dupilumab in improving participant reported outcomes including health related quality of life. * The dupilumab systemic exposure and incidence of anti-drug antibodies. * The evaluate the association between dupilumab treatment and pediatric immune responses to vaccines: any vaccination for tetanus, diphtheria, pertussis and/or seasonal trivalent/quadrivalent influenza vaccine.
Study Details
Timeline
Interventions
Pharmaceutical form: Solution Route of administration: Subcutaneous
Pharmaceutical form: Solution Route of administration: Subcutaneous
Pharmaceutical form: Aerosol, capsules, tablets, oral solution Route of administration: Inhaled, oral
Pharmaceutical form: Nebulized, aerosol Route of administration: Inhaled