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

Recruiting now

Conditions studied: Generalized Myasthenia Gravis, Anti-AChR Antibody Positive

In brief

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

Key facts

Study ID

NCT06967480

Run by

Alexion Pharmaceuticals, Inc.

People needed

40

Starts

2025-07-31

Expected to finish

2027-06-30

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Clinical Trial Site — Florence, Italy (enrolling)
• Clinical Trial Site — Parma, Italy (enrolling)
• Clinical Trial Site — Bologna, Italy (enrolling)
• Clinical Trial Site — Lecco, Italy (enrolling)
• Clinical Trial Site — Brescia, Italy (enrolling)
• Clinical Trial Site — Milan, Italy (enrolling)
• Clinical Trial Site — San Giovanni Rotondo, Italy (enrolling)
• Clinical Trial Site — Sassari, Italy (enrolling)
• Clinical Trial Site — Bergamo, Italy (enrolling)
• Clinical Trial Site — Palermo, Italy
• Clinical Trial Site — Pavia, Italy
• Clinical Trial Site — Pisa, Italy
• Clinical Trial Site — Roma, Italy
• Clinical Trial Site — Salerno, Italy
• Clinical Trial Site — Torino, Italy
• Clinical Trial Site — Bologna, Italy
• Clinical Trial Site — Imperia, Italy
• Clinical Trial Site — Messina, Italy
• Clinical Trial Site — Milan, Italy
• Clinical Trial Site — Naples, Italy
• Clinical Trial Site — Novara, Italy
• Clinical Trial Site — Orbassano, Italy
• Clinical Trial Site — Padova, Italy

Full record on ClinicalTrials.gov

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