Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
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|ClinicalTrials.gov Identifier: NCT03920293|
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : May 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Generalized Myasthenia Gravis||Biological: Ravulizumab Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||All investigative site personnel, sponsor staff, sponsor designees, staff directly associated with the conduct of the study, and all participants will be blinded to treatment assignments.|
|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|
|Actual Study Start Date :||March 26, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2023|
Participants will receive ravulizumab for the duration of the study.
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.
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.
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.
- Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26 [ Time Frame: Baseline, Week 26 ]To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the MG-ADL profile.
- Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26 [ Time Frame: Baseline, Week 26 ]To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the QMG total score.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920293
|Contact: Alexion Pharmaceuticals Inc.||email@example.com|
|United States, Florida|
|University of South Florida - Carol & Frank Morsani Center for Advanced Healthcare||Recruiting|
|Tampa, Florida, United States, 33612|
|United States, Nevada|
|Las Vegas Clinic||Recruiting|
|Las Vegas, Nevada, United States, 89145|
|United States, Texas|
|Central Texas Neurology Consultants||Recruiting|
|Round Rock, Texas, United States, 78681|