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Efficacy and Safety Study of Benralizumab to Reduce OCS Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus LABA and Chronic OCS Therapy

NCT02075255 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2018-06-08

Study results available
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Summary

The purpose of this trial is to confirm if benralizumab can reduce the use of maintenance OCS in systemic corticosteroid dependent patients with severe refractory asthma with elevated eosinophils.

Conditions

Interventions

BIOLOGICAL

Benralizumab

Benralizumab administered subcutaneously every 4 weeks

BIOLOGICAL

Placebo

Placebo subcutaneously on study week 0 until study week 24 inclusive.

BIOLOGICAL

Benralizumab

Benralizumab administered subcutaneously every 4 weeks for the first 3 dose and then every 8 weeks; matching placebo subcutaneously at the 4 week interim to maintain the blind.

Sponsors & Collaborators

Principal Investigators

  • Parameswaran Nair, MD,PhD,FRCP,FRCPC · St Joseph's Healthcare Hamilton Firestone Institute for Respiratory Health 50 Charlton Avenue East Hamilton

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-04-28
Primary Completion
2016-08-08
Completion
2016-08-08

Countries

  • United States
  • Argentina
  • Bulgaria
  • Canada
  • Chile
  • France
  • Germany
  • Poland
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • Ukraine

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 NCT02075255 on ClinicalTrials.gov