MedTrace Logo

A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA

NCT02258542 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2133

Last updated 2019-08-21

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020.

Conditions

Interventions

BIOLOGICAL

Benralizumab

Benralizumab administered subcutaneously

BIOLOGICAL

Benralizumab

Benralizumab administered subcutaneously

Sponsors & Collaborators

Principal Investigators

  • William W. Busse, M.D., Professor of Medicine · Allergy, Pulmonary, and Critical Care Medicine 600 Highland Avenue; Madison, WI

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-11-19
Primary Completion
2017-10-18
Completion
2018-07-02

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Czechia
  • France
  • Germany
  • Japan
  • Peru
  • Philippines
  • Poland
  • Romania
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

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 NCT02258542 on ClinicalTrials.gov