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NCT06967480Recruiting

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

MG-EVOLUTION. Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis: A Real-World Study With Biomarker Analysis

Source: ClinicalTrials.gov · Last updated 5 Feb 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
40 (estimated)
First submitted
5 May 2025
Start date
31 Jul 2025
Primary completion date
30 Jun 2027
Lead sponsor
Alexion Pharmaceuticals, Inc.
NCT number
NCT06967480

What you commit to

  • Study type: Observational
  • Planned participants: 40
  • From 31 Jul 2025 to the primary completion date, 30 Jun 2027
  • 21 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • Previous or current participation to other interventional studies

Other illness

  • Hypersensitivity to the active substance or to any of the excipients of the study product

Other

  • Patient unable to understand and sign the informed consent
  • Patient for whom the study product is contraindicated according to SmPC
  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BergamoItalyRecruiting
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BolognaItalyNot yet recruiting
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BresciaItalyRecruiting
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FlorenceItalyRecruiting
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ImperiaItalyNot yet recruiting
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LeccoItalyRecruiting
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MessinaItalyNot yet recruiting
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MilanItalyRecruiting
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NaplesItalyNot yet recruiting
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NovaraItalyNot yet recruiting
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OrbassanoItalyNot yet recruiting
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PadovaItalyNot yet recruiting
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PalermoItalyNot yet recruiting
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ParmaItalyRecruiting
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PaviaItalyNot yet recruiting
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PisaItalyNot yet recruiting
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RomaItalyNot yet recruiting
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SalernoItalyNot yet recruiting
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San Giovanni RotondoItalyRecruiting
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SassariItalyRecruiting
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Coordinator of this site? Confirm its status
TorinoItalyNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.