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NCT07596784
Efficacy and Safety of Ravulizumab in Chinese Adults Participants With Generalized Myasthenia Gravis (gMG)
Conditions: Generalized Myasthenia Gravis, gMG
Sex: All
Ages: 18 Years – 130 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 20
Sponsor: Alexion Pharmaceuticals, Inc.
Location: Research Site Beijing
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT07596784). StuddyBuddy aggregates publicly available trial information.