- To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in patients with persistent asthma.
- To evaluate the safety and tolerability of dupilumab. To evaluate the effect of dupilumab in improving patient-reported outcomes including health-related quality of life.
- To evaluate dupilumab systemic exposure and incidence of antidrug antibodies.
Study Type: Interventional
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma
Study Start Date: April 2015
Estimated Study Completion Date: November 2017
Primary Completion Date: July 29, 2017 (Final data collection date for primary outcome measure)
- Experimental: dupilumab dose 1
- Experimental: dupilumab dose 2
- Placebo Comparator: placebo (for dupilumab dose 1)
- Placebo Comparator: placebo (for dupilumab dose 2)
|Date last updated at source||2017-09-11|
|Study start date||2015-04-01|
|Estimated primary completion date||2017-11-01|