CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 651 enrolled
Drug / intervention
Mepolizumabbiological
Likely dose
Mepolizumab 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01842607
NCT01842607Phase 3Completed
CompareCT.gov

A Multi-centre, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in theMEA115588 or MEA115575 Trials

GlaxoSmithKline·interventional·Posted Apr 29, 2013·Updated Aug 6, 2018

In Brief

A Phase 3 clinical trial evaluating Mepolizumab for Asthma. Completed, enrolled 651 participants across 137 sites in 19 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Australia, Belgium, Canada, Chile, Czechia, France, Germany, Italy, Japan, Mexico, Netherlands, Poland, Russia, South Korea, Spain, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 29, 2013
Enrollment StartMay 27, 2013
Primary CompletionMar 13, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.2 years ago

Interventions

Mepolizumabbiological

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