Early ravulizumab for anti‑AChR antibody–positive generalized myasthenia gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clinical Trial Site
  Bergamo, Italy Recruiting
• Clinical Trial Site
  Bologna, Italy Recruiting
• Clinical Trial Site
  Brescia, Italy Recruiting
• Clinical Trial Site
  Florence, Italy Recruiting
• Clinical Trial Site
  Lecco, Italy Recruiting
• Clinical Trial Site
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Alexion Pharmaceuticals, Inc. (Sponsor)
• Email: clinicaltrials@alexion.com
• Phone: 1-855-752-2356

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ravulizumab for Generalized Myasthenia Gravis in Chinese Adults

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  Recruiting at 8 sites Phase 3 Alexion Pharmaceuticals, Inc. · Beijing and 9 other locations · NCT07596784

• Oral steroid tapering for adults with generalized myasthenia gravis on ravulizumab.

  This study will try a predefined prednisone taper to see if adults with generalized myasthenia gravis on ravulizumab can safely reduce their daily steroid dose.

  Recruiting Phase 4 Alexion Pharmaceuticals, Inc. · Chicago, Illinois and 11 other locations · NCT07221838

• SHR-2173 injection added to standard care for generalized myasthenia gravis

  This Phase 2 trial tests whether SHR-2173 added to usual treatment helps adults with generalized myasthenia gravis more than a placebo add-on.

  Recruiting at 2 sites Phase 2 Guangdong Hengrui Pharmaceutical Co., Ltd · Changsha, Hunan and 1 other locations · NCT07622342

• Tracking Real-Life Myasthenia Gravis Symptoms in Patients on Rozanolixizumab

  This observational study follows adults with generalized myasthenia gravis who are treated with Rozanolixizumab to see how their symptoms and fatigue change in real life.

  Recruiting Centre Hospitalier Universitaire de Nice · Nice, Alpes-maritimes and 10 other locations · NCT07570589

• Ravulizumab in Chinese adults with NMOSD

  This study tests ravulizumab in Chinese adults with NMOSD who are AQP4 antibody positive to see if it helps reduce relapses and is safe.

  Recruiting Phase 3 Alexion Pharmaceuticals, Inc. · Beijing and 9 other locations · NCT07557420

• Early ravulizumab for adults with myasthenic crisis in the ICU

  This project will test whether giving ravulizumab early to adults with AChR-positive generalized myasthenia gravis who are in the ICU for a myasthenic crisis helps speed recovery.

  Recruiting at 5 sites Centre Hospitalier Universitaire de Nice · Nice, Alpes-maritimes and 7 other locations · NCT07411963

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.