CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 175 enrolled
Drug / intervention
Ravulizumab +1 morebiological
Likely dose
Ravulizumab 10 milligramsfrom 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/NCT03920293
NCT03920293Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis

Alexion Pharmaceuticals, Inc.·interventional·Posted Apr 18, 2019·Updated May 28, 2024

In Brief

A Phase 3 clinical trial evaluating Ravulizumab and Placebo for Generalized Myasthenia Gravis. Completed, enrolled 175 participants across 106 sites in 15 countries.

Detailed Summary

The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeneralized Myasthenia Gravis
CountriesAustria, Canada, Czechia, Denmark, France, Germany, Israel, Italy, Japan, Netherlands, Portugal, South Korea, Spain, Switzerland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedApr 18, 2019
Enrollment StartMar 12, 2019
Primary CompletionMay 11, 2021
Study CompletionMay 25, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.2 years ago

Interventions

Ravulizumabbiological

Concentrated sterile, preservative-free aqueous solution (10 milligrams \[mg\]/milliliter \[mL\]) in single-use, 30-mL vial for intravenous (IV) infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.

Placebodrug

Matching, sterile, preservative-free aqueous solution in single-use, 30-mL vial for IV infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.