Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT02948959
Brief 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.
Detailed Description:
The total study duration per participant was up to 69 weeks, consisted of a screening period of 3-5 weeks, a randomized treatment period of 52 weeks and a post-treatment period of 12 weeks.
Study:
NCT02948959
Study Brief:
Protocol Section:
NCT02948959