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Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma

NCT01000506 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 621

Last updated 2018-01-24

Study results available
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Summary

The purpose of this study is to show whether mepolizumab given every 4 weeks intravenously (i.v.) can reduce the frequency of asthma exacerbations in subjects with severe asthma despite receiving high doses of standard asthma medications. The study will look at different doses of mepolizumab in comparison to a placebo.

Conditions

Interventions

BIOLOGICAL

Mepolizumab 750

Mepolizumab 750mg every four weeks by i.v.

BIOLOGICAL

Mepolizumab 250

Mepolizumab 250mg every four weeks by i.v.

BIOLOGICAL

Mepolizumab 75

Mepolizumab 75mg every four weeks by i.v.

DRUG

Placebo saline

Placebo saline every four weeks by i.v.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-11-01
Primary Completion
2012-03-23
Completion
2012-03-23

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Chile
  • France
  • Germany
  • Poland
  • Romania
  • Russia
  • South Korea
  • Ukraine
  • United Kingdom

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 NCT01000506 on ClinicalTrials.gov