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

View full details

Comments

You will need to login, to leave a comment.

epgonline.org is not monitored for collection of adverse event reports. Any adverse events should be reported to your national reporting agency and/or the manufacturer.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Allergic Rhinitis

Allergic Rhinitis

Allergic rhinitis causes great strain on the workforce. Help to reduce sick days and improve productivity with appropriate treatment options.

+ 4 more

Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD)

View highlights from recent congresses presented in new expert videos with leading physicians.

+ 7 more

Chronic Spontaneous Urticaria (CSU)

Chronic Spontaneous Urticaria (CSU)

Use our patient case studies to discover how experts diagnose and treat chronic spontaneous urticaria.

+ 7 more

Load more

Related Content