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]
Recruiting

Study Details

Medical Condition
  • Generalized Myasthenia Gravis
  • Unmapped
Study Drug
  • Drug: Ravulizumab
Date
Jul 2025 - Jun 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
  • 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
Jul 2025 - Jun 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
  • 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
Recruiting
Location
Clinical Trial Site
Bologna, Italy
Status
Not yet recruiting
Location
Clinical Trial Site
Brescia, Italy
Status
Not yet recruiting
Location
Clinical Trial Site
Florence, Italy
Status
Recruiting
Location
Clinical Trial Site
Imperia, Italy
Status
Not yet recruiting
Location
Clinical Trial Site
Lecco, Italy
Status
Recruiting
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