CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 12 enrolled
Drug / intervention
Eculizumabdrug
Likely dose
Not stated in 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/NCT03759366
NCT03759366Phase 3Completed
CompareCT.gov

An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients With Refractory Generalized Myasthenia Gravis

Alexion Pharmaceuticals, Inc.·interventional·Posted Nov 30, 2018·Updated Dec 11, 2024

In Brief

A Phase 3 clinical trial evaluating Eculizumab for Myasthenia Gravis and 2 related conditions. Completed, enrolled 12 participants across 11 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyasthenia Gravis, Myasthenia Gravis, Juvenile Form, Myasthenia Gravis, Generalized
CountriesJapan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedNov 30, 2018
Enrollment StartDec 28, 2018
Primary CompletionJan 6, 2022
Study CompletionNov 6, 2023
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.6 years ago

Interventions

Eculizumabdrug

Eculizumab will be administered by IV infusion.