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Evaluation of Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of Ravulizumab Administered Intravenously in Pediatric Participants With Generalized Myasthenia Gravis (gMG)
Sponsor: Alexion Pharmaceuticals, Inc.
Summary
The primary purpose of this study is to characterize the pharmacokinetics and pharmacodynamics of treatment with ravulizumab intravenous infusion in pediatric participants with gMG.
Official title: A Phase 3, Open-label, Single-arm, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of Ravulizumab Administered Intravenously in Pediatric Participants (6 to < 18 Years of Age) With Generalized Myasthenia Gravis (gMG)
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2023-06-24
Completion Date
2028-06-30
Last Updated
2026-02-19
Healthy Volunteers
No
Conditions
Interventions
Ravulizumab
Ravulizumab will be administered by intravenous (IV) infusion.
Locations (11)
Research Site
Los Angeles, California, United States
Research Site
Boston, Massachusetts, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Milan, Italy
Research Site
Roma, Italy
Research Site
Torino, Italy
Research Site
Itabashi-ku, Japan
Research Site
Belgrade, Serbia
Research Site
Belgrade, Serbia
Research Site
Bern, Switzerland