NCT05644561

Evaluation of PK, PD, Efficacy, Safety, and Immunogenicity of IV Ravulizumab in Pediatric Participants With Generalized Myasthenia Gravis

Phase 3, Open-label, Single-arm, Multicenter Study Evaluating Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of IV Ravulizumab in Pediatric Participants (6 to <18 Years) With Generalized Myasthenia Gravis (gMG)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Generalized Myasthenia Gravis
• gMG

Interventions

Type	Name	Description
DRUG	Ravulizumab	Ravulizumab will be administered by intravenous (IV) infusion.

Timeline

• Start date: 2023-06-24
• Primary completion: 2026-07-15
• Completion: 2028-06-30
• First posted: 2022-12-09
• Last updated: 2026-04-17

Locations

11 sites across 5 countries: United States, Italy, Japan, Serbia, Switzerland

Regulatory

• FDA-regulated drug study