At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 125 enrolled
Drug / intervention
Eculizumab +1 morebiological
Likely dose
Eculizumab 900 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.
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)
In Brief
A Phase 3 clinical trial evaluating Eculizumab and Placebo for Refractory Generalized Myasthenia Gravis. Completed, enrolled 125 participants across 114 sites in 21 countries.
Detailed Summary
The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRefractory Generalized Myasthenia Gravis
CountriesArgentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Netherlands, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 2013
Enrollment StartDec 2013
Primary CompletionFeb 2016
Study CompletionJun 2016
TodayJul 2026
First PostedNov 28, 2013
Enrollment StartDec 1, 2013
Primary CompletionFeb 1, 2016
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.6 years ago
Interventions
Eculizumabbiological
Induction Phase: 900 mg IV weekly X 4 Maintenance Phase: 1200 mg IV every 2 weeks during Weeks 4-26
Placebodrug
Placebo