NCT02301624

Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis

A Phase III, Open-label Extension Trial of ECU-MG-301 to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of eculizumab in the treatment of refractory generalized myasthenia gravis (gMG) as an extension study for the participants who previously completed Study ECU-MG-301(NCT01997229).

Detailed description

ECU-MG-302 was an extension study designed to provide the participants who completed Study ECU-MG-301 an opportunity to receive eculizumab and collect clinical data to provide long-term safety and efficacy information on eculizumab in participants with refractory gMG. After receiving blinded study treatment (eculizumab or placebo) in Study ECU-MG-301 for 26 weeks, participants were eligible to enroll in the ECU-MG-302 extension study. Participants were to enter Study ECU-MG-302 within 2 weeks after completing their Week 26 visit in Study ECU-MG-301. Study ECU-MG-302 consisted of a 4-week Blind Induction Phase to preserve the blinded nature of Study ECU-MG-301, an Open-Label Maintenance Phase (up to 4 years), and a Safety Follow-up visit 8 weeks after the last dose for participants who withdrew from the study or discontinued eculizumab treatment at any time and for any reason after receiving any amount of eculizumab.

Conditions

• Refractory Generalized Myasthenia Gravis

Interventions

Type	Name	Description
BIOLOGICAL	Eculizumab	Intravenous administration of eculizumab.
DRUG	Placebo	Intravenous administration of matching placebo. Participants received placebo only during the Blind Induction Phase.

Timeline

• Start date: 2014-11-12
• Primary completion: 2019-01-15
• Completion: 2019-01-15
• First posted: 2014-11-26
• Last updated: 2020-02-05
• Results posted: 2020-02-05

Locations

60 sites across 17 countries: United States, Argentina, Belgium, Brazil, Canada, Czechia, Denmark, Finland, Hungary, Italy, Japan, Netherlands, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom