Data from Clinicaltrials.gov - Curated by EPG Health - Last updated 15 November 2017

Primary Objective:
- 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.

purpose

Primary Objective:
- 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.

Secondary Objectives:
- 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
Allocation: Randomized
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)

Arms:
- Experimental:
Dupilumab
- Placebo Comparator: Placebo

Category Value
Date last updated at source 26-Oct-17
Study type(s) Interventional
Expected enrolment 180
Study start date 15-Oct-15
Estimated primary completion date 20-Sep-17

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