Trials / Completed
CompletedNCT03920293
Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 175 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 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. |
| 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. |
Timeline
- Start date
- 2019-03-12
- Primary completion
- 2021-05-11
- Completion
- 2023-05-25
- First posted
- 2019-04-18
- Last updated
- 2024-05-28
- Results posted
- 2022-05-26
Locations
106 sites across 15 countries: United States, Austria, Canada, Czechia, Denmark, France, Germany, Israel, Italy, Japan, Netherlands, Portugal, South Korea, Spain, Switzerland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03920293. Inclusion in this directory is not an endorsement.