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:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
Recruiting
Study Details
Medical Condition
- Generalized Myasthenia Gravis
- Unmapped
Study Drug
- Drug: Ravulizumab
Date
Jun 2023 - Jul 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Diagnosis of gMG confirmed by a positive serologic test for anti-AChR antibodies (Abs) obtained at Screening and/or during Screening Period
- Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to Class IV at Screening
- Participants receiving treatment must be on a stable dosing regimen of adequate duration prior to Screening and during the Screening Period.
- Eculizumab-experienced participants must have been enrolled and treated with eculizumab in Study ECU-MG-303 for at least 6 months (180 days) and must have been on a stable dose for ≥ 2 months (60 days) prior to Screening.
- All participants must be vaccinated against meningococcal infection
Exclusion Criteria
- Medical Conditions
- Any untreated thymic malignancy, carcinoma, or thymoma.
- Participants with a history of treated benign thymoma
- History of thymectomy, thymomectomy, or any thymic surgery within the 12 months prior to Screening
- History of N meningitidis infection
- Known to be human immunodeficiency virus (HIV) positive
- History of unexplained infections
- Known or suspected history of drug or alcohol abuse or dependence within 1 year prior to the start of the Screening Period
Sex
Female & Male
Age
N/A
Study Details
Medical Condition
- Generalized Myasthenia Gravis
- Unmapped
Study Drug
- Drug: Ravulizumab
Date
Jun 2023 - Jul 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Diagnosis of gMG confirmed by a positive serologic test for anti-AChR antibodies (Abs) obtained at Screening and/or during Screening Period
- Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to Class IV at Screening
- Participants receiving treatment must be on a stable dosing regimen of adequate duration prior to Screening and during the Screening Period.
- Eculizumab-experienced participants must have been enrolled and treated with eculizumab in Study ECU-MG-303 for at least 6 months (180 days) and must have been on a stable dose for ≥ 2 months (60 days) prior to Screening.
- All participants must be vaccinated against meningococcal infection
Exclusion Criteria
- Medical Conditions
- Any untreated thymic malignancy, carcinoma, or thymoma.
- Participants with a history of treated benign thymoma
- History of thymectomy, thymomectomy, or any thymic surgery within the 12 months prior to Screening
- History of N meningitidis infection
- Known to be human immunodeficiency virus (HIV) positive
- History of unexplained infections
- Known or suspected history of drug or alcohol abuse or dependence within 1 year prior to the start of the Screening Period
Protocol 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.
Trial Locations
Location
Status
Location
Research Site
Los Angeles, California, United States, 90078
Status
Recruiting
Location
Research Site
San Francisco, California, United States, 94143
Status
Recruiting
Location
Research Site
Chicago, Illinois, United States, 60611
Status
Recruiting
Location
Research Site
Boston, Massachusetts, United States, 02115
Status
Recruiting
Location
Research Site
Chapel Hill, North Carolina, United States, 27514
Status
Recruiting
Location
Research Site
Akron, Ohio, United States, 44308
Status
Recruiting
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