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Early ravulizumab for 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

Observational Alexion Pharmaceuticals, Inc. · NCT06967480

This study tests whether starting ravulizumab early can improve daily muscle weakness and function for people with anti‑AChR antibody–positive generalized myasthenia gravis.

Quick facts

Study typeObservational
Enrollment40 (estimated)
Ages18 Years and up
SexAll
SponsorAlexion Pharmaceuticals, Inc. Industry-sponsored
Drugs / interventionsRavulizumab, rituximab
Locations23 sites (Bergamo and 22 other locations)
Trial IDNCT06967480 on ClinicalTrials.gov

What this trial studies

This observational study follows people with anti‑AChR antibody–positive generalized myasthenia gravis who begin ravulizumab as part of routine care within three years of disease onset. Eligible participants have MGFA class IIb–IV and must meet national (AIFA) criteria for ravulizumab reimbursement; meningococcal vaccination or appropriate prophylaxis is required before treatment. The primary outcome is change in MG‑ADL scores over the follow‑up period, with other clinical and safety data collected from the treating centers in Bergamo and Bologna. Data will characterize real‑world effectiveness and tolerability of early complement inhibition in this patient population.

Who should consider this trial

Good fit: Adults with generalized MG who are anti‑AChR antibody positive, within three years of symptom onset, MGFA class IIb–IV, eligible for ravulizumab under AIFA, and able to receive meningococcal vaccination are ideal candidates.

Not a fit: Patients who are seronegative for anti‑AChR antibodies, have purely ocular MG, have disease onset more than three years earlier, or cannot receive ravulizumab are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, early ravulizumab could lead to faster improvement in daily symptoms and reduce reliance on other immunosuppressive treatments.

How similar studies have performed: Complement inhibitors such as eculizumab and ravulizumab have shown benefit in anti‑AChR positive gMG in prior studies, but using these drugs early in the disease course remains less well studied.

Eligibility criteria

Show full inclusion / 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

Where this trial is running

Bergamo and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Generalized Myasthenia GravisAnti-AChR Antibody PositiveAnti-AChR Antibody-PositivegMGRavulizumab
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.