Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
Study identifier:ALXN1210-MG-306
ClinicalTrials.gov identifier:NCT03920293
EudraCT identifier:2018-003243-39
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Generalized Myasthenia Gravis
Phase
Phase 3
Healthy volunteers
No
Study drug
Placebo
Sex
All
Actual Enrollment
175
Study type
Interventional
Age
n/a - n/a
Date
Study Start Date: 12 Mar 2019
Primary Completion Date: 11 May 2021
Study Completion Date: 25 May 2023
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2024 by Alexion Pharmaceuticals, Inc.
Sponsors
Alexion Pharmaceuticals, Inc.
Collaborators
-
Inclusion and exclusion criteria
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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. |
