Ravulizumab for Generalized Myasthenia Gravis in Chinese Adults

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 Phase 3 interventional study in Chinese adults with acetylcholine receptor–positive generalized MG evaluates the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab. Participants must have MG for at least 6 months, moderate to severe disease, and be up to date on meningococcal vaccination. The study uses a weight-based dosing approach and includes standard safety monitoring in multiple Chinese sites.

Why it matters

Who can join: the full rules

Inclusion (key)

* Confirmed generalized MG: Diagnosis ≥6 months before screening, anti-AChR antibody positive, and supportive diagnostic evidence (e.g., abnormal SFEMG/RNS or response to anticholinesterase therapy).
* Disease severity: MGFA Class II-IV at screening.
* Symptoms threshold: MG-ADL ≥6 at screening and on Day 1.
* Meningococcal vaccination: Up to date within 3 years or vaccinated before first dose to mitigate risk with complement inhibition.
* Body weight: ≥40 kg.
* Vaccinated against meningococcal infections within the 3 years prior to, or at the time of, initiating study drug.

Exclusion (key)

* Thymic disease:

  * Untreated thymic malignancy/carcinoma/thymoma excluded.
  * Prior thymic malignancy allowed only if treatment completed \>5 years, no recurrence in last 5 years, and clear CT/MRI within 6 months.
  * Prior benign thymoma allowed if confirmed benign, treatment \>12 months ago, no recurrence in last 12 months, and clear CT/MRI within 6 months; otherwise follow malignancy rules.
  * Thymectomy within the last 12 months
* Infection risk:

  * History of meningococcal disease or unresolved infection, or active systemic infection within 14 days of Day 1 excluded.
  * Persistent/recurrent infections in past 12 months that add risk
  * HIV, active HBV (HBsAg+ or anti-HBc+ with anti-HBs-), or active HCV (unless documented successful treatment/SVR)
* Safety/medical status:

  * Hypersensitivity to study drug components (including murine proteins)
  * Recent hospitalization ≥24 hours within 28 days of screening
  * Substance use disorder per DSM within 12 months.
  * Recent/other malignancy within 5 years (except as above for thymic).
* Prior/Concomitant Therapy

  * Complement inhibitor within \< 5 half-lives before Day 1.
  * Human neonatal Fc receptor (FcRn) inhibitor within \< 5 half-lives before Day 1.
  * Rituximab, ocrelizumab or other B cell-depleting therapy within ≤ 6 months (180 days) before Day 1.
  * Periodic (chronic) administration of PP/PE, or IVIg as maintenance therapy received or scheduled within ≤ 6 months before Day 1
* Key labs:

  * ALT \>2× ULN, direct bilirubin \>2× ULN.
  * eGFR \<30 mL/min/1.73 m² or on dialysis.
  * Any other clinically significant lab abnormality making participation unsafe.

Note: Other protocol-defined criteria may apply and should be verified during full eligibility review.

Where it's running

• Research Site
  Beijing, China Recruiting
• Research Site
  Fuzhou, China Recruiting
• Research Site
  Jinan, China Recruiting
• Research Site
  Shanghai, China Recruiting
• Research Site
  Shijiazhuang, China Recruiting
• Research Site
  Taiyuan, China 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.

• 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

• ADAPT Forward master protocol testing multiple regimens for generalized myasthenia gravis

  This platform tests several drug regimens, including efgartigimod IV and empasiprubart IV, in adults with generalized myasthenia gravis to find safer and more effective treatment combinations.

  Recruiting at 37 sites argenx · Carlsbad, California and 36 other locations · NCT07294170

• Adding empasiprubart to efgartigimod for AChR-antibody positive generalized myasthenia gravis

  This trial will test whether adding empasiprubart to efgartigimod infusions helps people with AChR-antibody positive generalized myasthenia gravis who have only had a partial response to efgartigimod.

  Recruiting at 33 sites Phase 2 argenx · Carlsbad, California and 32 other locations · NCT07284420

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

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

  Recruiting at 9 sites Alexion Pharmaceuticals, Inc. · Bergamo and 22 other locations · NCT06967480

• Evaluating gefurulimab for treating pediatric patients with generalized myasthenia gravis

  This study is testing a new drug called gefurulimab to see if it can help children and teens with generalized myasthenia gravis feel better.

  Recruiting at 11 sites Phase 3 Alexion Pharmaceuticals, Inc. · Washington D.C., District of Columbia and 12 other locations · NCT06607627

• Empasiprubart IV in people with AChR-Ab positive generalized myasthenia gravis

  This study tests whether empasiprubart given by IV can help people with AChR-Ab positive generalized myasthenia gravis feel better and have fewer symptoms.

  Recruiting at 14 sites Phase 2 argenx · Carlsbad, California and 13 other locations · NCT07673627

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.