Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis

Study Identifier:
D9281R00002
ClinicalTrials.gov Identifier:
NCT06967480
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
1-855-752-2356 or [email protected]
Will Be Recruiting

Study Details

Medical Condition
  • Generalized Myasthenia Gravis
  • Unmapped
Study Drug
  • Drug: Ravulizumab
Date
Sep 2025 - Apr 2027
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Diagnosis of MG confirmed by:
  • History of a positive serologic test for anti-AChR antibodies, and
  • One of the following:
  • History of abnormal neuromuscular transmission test demonstrated by singlefibre electromyography or repetitive nerve stimulation
  • History of positive anticholinesterase test (e.g., edrophonium chloride test); or
  • Patient demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician
  • Disease duration from MG onset ≤ 3 years before T-4 (Enrolment);
  • MGFA class IIb to IV;
  • Patient eligible for Ravulizumab treatment based on AIFA reimbursement criteria
  • Vaccination cycle for Neisseria meningitidis completed at least two weeks before Ravulizumab initiation or antibiotics chemoprophylaxis according to the SmPC.
Exclusion Criteria
  • Patient unable to understand and sign the informed consent
  • Hypersensitivity to the active substance or to any of the excipients of the study product
  • Patient for whom the study product is contraindicated according to SmPC
  • Previous treatment with C5 inhibitors
  • Last rituximab infusion performed \< 6 months before T-4 (Enrolment)
  • Last infusion with FcRn blockers performed \< 3 months before T-4 (Enrollment)
  • Pregnant or lactating or planning a pregnancy during the study
  • Patient who plan to relocate during the study
  • Patient who are unsure of following the visit schedule
  • Patient unable to complete questionnaires
  • Previous or current participation to other interventional studies
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Generalized Myasthenia Gravis
  • Unmapped
Study Drug
  • Drug: Ravulizumab
Date
Sep 2025 - Apr 2027
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Diagnosis of MG confirmed by:
  • History of a positive serologic test for anti-AChR antibodies, and
  • One of the following:
  • History of abnormal neuromuscular transmission test demonstrated by singlefibre electromyography or repetitive nerve stimulation
  • History of positive anticholinesterase test (e.g., edrophonium chloride test); or
  • Patient demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician
  • Disease duration from MG onset ≤ 3 years before T-4 (Enrolment);
  • MGFA class IIb to IV;
  • Patient eligible for Ravulizumab treatment based on AIFA reimbursement criteria
  • Vaccination cycle for Neisseria meningitidis completed at least two weeks before Ravulizumab initiation or antibiotics chemoprophylaxis according to the SmPC.
Exclusion Criteria
  • Patient unable to understand and sign the informed consent
  • Hypersensitivity to the active substance or to any of the excipients of the study product
  • Patient for whom the study product is contraindicated according to SmPC
  • Previous treatment with C5 inhibitors
  • Last rituximab infusion performed \< 6 months before T-4 (Enrolment)
  • Last infusion with FcRn blockers performed \< 3 months before T-4 (Enrollment)
  • Pregnant or lactating or planning a pregnancy during the study
  • Patient who plan to relocate during the study
  • Patient who are unsure of following the visit schedule
  • Patient unable to complete questionnaires
  • Previous or current participation to other interventional studies

Protocol Summary

The primary objective of the study is to evaluate the effectiveness of Ravulizumab in improving MG-ADL in an early-stage AChR+ gMG population.

Trial Locations

Location
Status
Location
Clinical Trial Site
Bergamo, Italy
Status
N/A
Location
Clinical Trial Site
Bologna, Italy
Status
N/A
Location
Clinical Trial Site
Brescia, Italy
Status
N/A
Location
Clinical Trial Site
Florence, Italy
Status
N/A
Location
Clinical Trial Site
Imperia, Italy
Status
N/A
Location
Clinical Trial Site
Lecco, Italy
Status
N/A
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