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Clinical Trials in China / NCT07596784
Recruiting Phase 3

Efficacy and Safety of Ravulizumab in Chinese Adults Participants With Generalized Myasthenia Gravis (gMG)

NCT07596784 · tracked via the Priya Life Science China tracker
Sponsor
Alexion Pharmaceuticals, Inc.
Phase
Phase 3
Started
2026-07-20
Last updated
2026-09-11

Condition(s) studied

Generalized Myasthenia GravisgMG

Investigational drug(s) / intervention(s)

Ravulizumab

Ravulizumab: Participants will receive ravulizumab via intravenous (IV) infusion.

Study summary

The primary purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in Chinese adult participants with Acetylcholine receptor (AChR) + Generalized Myasthenia Gravis (gMG).

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Research Site Beijing China Recruiting
Research Site Changchun China Not Yet Recruiting
Research Site Fuzhou China Not Yet Recruiting
Research Site Jinan China Not Yet Recruiting
Research Site Shanghai China Recruiting
Research Site Shijiazhuang China Recruiting
Research Site Taiyuan China Recruiting
Research Site Tianjin China Not Yet Recruiting
Research Site Wuhan China Not Yet Recruiting
Research Site Zhengzhou China Recruiting

On this site

📄 Ultomiris (ravulizumab) drug profile →

More Alexion Pharmaceuticals, Inc. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07596784 on ClinicalTrials.gov ↗ ← All trials in China