- To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in patients with severe steroid-dependent asthma.
- To evaluate the safety and tolerability of dupilumab.
- To evaluate the effect of dupilumab in improving patient-reported outcomes.
- To evaluate dupilumab systemic exposure and the incidence of treatment-emergent antidrug antibodies.
Study Type: Interventional
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Severe Steroid Dependent Asthma
Estimated Enrollment: 180
Actual Study Start Date: October 15, 2015
Estimated Study Completion Date: November 15, 2017
Primary Completion Date: September 20, 2017 (Final data collection date for primary outcome measure)
- Experimental: Dupilumab
- Placebo Comparator: Placebo
|Date last updated at source||2017-10-26|
|Study start date||2015-10-15|
|Estimated primary completion date||2017-09-20|