Last updated on June 2019

Evaluation of Dupilumab in Children With Uncontrolled Asthma

Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02948959

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Investigational Site Number 840001

Rolling Hills Estates, CA United States
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Investigational Site Number 036003

Parkville/Melbourne, Australia
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Recruitment Status: Open

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