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drugset / Trial / NCT03759366

A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG)

NCT03759366 ↗

Phase 3 Completed 12 enrolled Alexion Pharmaceuticals, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of eculizumab in the treatment of pediatric refractory gMG based on change from Baseline in the Quantitative Myasthenia Gravis (QMG) score for disease severity.

Timeline

Start
2018-12-28
Primary completion
2022-01-06
Completion
2023-11-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Eculizumab Monoclonal antibody 300 mg Intravenous
Subject Eculizumab Monoclonal antibody 600 mg Intravenous
Subject Eculizumab Monoclonal antibody 900 mg Intravenous
Subject Eculizumab Monoclonal antibody 1200 mg Intravenous

Indications

generalized myasthenia gravis juvenile myasthenia gravis