Evaluation of Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of Ravulizumab Administered Intravenously in Pediatric Participants with Generalized Myasthenia Gravis (gMG)
Study identifier:ALXN1210-MG-319
ClinicalTrials.gov identifier:NCT05644561
EudraCT identifier:N/A
CTIS identifier:N/A
Recruiting
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)
Medical condition
Generalized Myasthenia Gravis
Phase
Phase 3
Healthy volunteers
No
Study drug
Ravulizumab
Sex
All
Estimated Enrollment
12
Study type
Interventional
Age
n/a - n/a
Date
Study Start Date: 24 Jun 2023
Estimated Primary Completion Date: 15 Jul 2026
Estimated Study Completion Date: 31 Jul 2028
Study design
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2024 by Alexion Pharmaceuticals, Inc.
Sponsors
Alexion Pharmaceuticals, Inc.
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Ravulizumab Intravenous (IV) Infusion All participants will receive a weight-based loading dose of ravulizumab IV on Day 1, followed by weight-based maintenance dose of ravulizumab on Day 15 and once every 8 weeks (q8w) thereafter for participants weighing ≥ 20 kg, or once every 4 weeks (q4w) for participants weighing < 20 kg, for a total of 122 weeks of treatment. | - |
