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Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

NCT01928771 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2681

Last updated 2017-05-03

Study results available
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Summary

The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.

Conditions

Interventions

BIOLOGICAL

Benralizumab

Benralizumab subcutaneously on study week 0 until study week 44 inclusive.

BIOLOGICAL

Placebo

Placebo subcutaneously on study week 0 until study week 44 inclusive.

Sponsors & Collaborators

Principal Investigators

  • Eugene R. Bleecker, MD, Professor of Medicine · Center for Genomics and Personalized Medicine Research, Medical Center Boulevard, Winston-Salem, North Carolina 27157

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-19
Primary Completion
2016-04-05
Completion
2016-04-05

Countries

  • United States
  • Australia
  • Brazil
  • Bulgaria
  • Czechia
  • France
  • Italy
  • Mexico
  • Peru
  • Poland
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01928771 on ClinicalTrials.gov