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A Study to Determine Long-term Safety of Mepolizumab in Asthmatic Subjects

NCT01842607 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 651

Last updated 2018-08-06

Study results available
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Summary

This is a multi-centre, open-label long-term safety study of 100 milligram (mg) mepolizumab administered subcutaneously (SC) every 4 weeks for 12 months in addition to standard of care in subjects who have severe, refractory asthma and a history of eosinophilic inflammation. Subjects who completed either MEA115588 or MEA115575 will be offered the opportunity to consent for this study.

Conditions

Interventions

BIOLOGICAL

Mepolizumab

Mepolizumab (a fully humanised IgG antibody) 100 mg injected SC once every 4 weeks for 12 months. Mepolizumab will be provided as a lyophilised cake in sterile vials

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-27
Primary Completion
2015-03-13
Completion
2015-03-13

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • Chile
  • Czechia
  • France
  • Germany
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • Russia
  • South Korea
  • Spain
  • 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 NCT01842607 on ClinicalTrials.gov