Evaluation of Dupilumab in Children With Uncontrolled Asthma (VOYAGE)

Brief Summary:
Primary Objective:
To evaluate the efficacy of dupilumab in children 6 to <12 years of age with uncontrolled persistent asthma.

Secondary Objectives:
To evaluate in children 6 to <12 years of age with uncontrolled persistent asthma:
- The safety and tolerability of dupilumab.
- To evaluate the effect of dupilumab in improving patient-reported outcomes (PROs) including health related quality of life (HRQoL).
- The dupilumab systemic exposure and incidence of anti-drug antibodies.
- To 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.

Detailed Description:
The total study duration per patient will be up to 69 weeks, consisting of a screening period of 3-5 weeks, a randomized treatment period of 52 weeks and a post-treatment period of 12 weeks.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 471 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: April 21, 2017
Estimated Primary Completion Date: July 22, 2021
Estimated Study Completion Date: July 22, 2021

Arms:
- Experimental: Dupilumab
- Placebo Comparator: Placebo