Status:
RECRUITING
Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Generalized Myasthenia Gravis
Anti-AChR Antibody Positive
Eligibility:
All Genders
18+ years
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 31 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06967480
Start Date
July 31 2025
End Date
June 30 2027
Last Update
September 19 2025
Active Locations (20)
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1
Clinical Trial Site
Bergamo, Italy
2
Clinical Trial Site
Bologna, Italy
3
Clinical Trial Site
Brescia, Italy
4
Clinical Trial Site
Florence, Italy