Study identifier:ALXN1210-MG-306
ClinicalTrials.gov identifier:NCT03920293
EudraCT identifier:2018-003243-39
CTIS identifier:N/A
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
Generalized Myasthenia Gravis
Phase 3
No
Placebo
All
175
Interventional
n/a - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2024 by Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Ravulizumab Participants will receive ravulizumab for the duration of the study. | Biological/Vaccine: Ravulizumab 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. Other Name: ALXN1210 Other Name: Ultomiris |
Placebo Comparator: Placebo Participants will receive placebo during the 26-week randomized-controlled period of the study, after which they will enter the open-label extension period of the study and receive ravulizumab. | Drug: Placebo 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. |