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

Primary Objective:
- To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in patients with persistent asthma.

purpose

Primary Objective:
- To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in patients with persistent asthma.

Secondary Objectives:
- 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
Allocation: Randomized
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
Enrollment: 1902
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)

Arms:
- Experimental:
dupilumab dose 1
- Experimental: dupilumab dose 2
- Placebo Comparator: placebo (for dupilumab dose 1)
- Placebo Comparator: placebo (for dupilumab dose 2)

Category Value
Date last updated at source 11-Sep-17
Study type(s) Interventional
Expected enrolment 1902
Study start date 01-Apr-15
Estimated primary completion date 01-Nov-17

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