NCT07596784招募中3 期
An Open-label, Single-arm, Multi-center, Interventional Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Chinese Adult Patients With Generalized Myasthenia Gravis (gMG)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 20
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •Human neonatal Fc receptor (FcRn) inhibitor within < 5 half-lives before Day
- •Rituximab, ocrelizumab or other B cell-depleting therapy within ≤ 6 months (180 days) before Day
- •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.
排除标准
- 未提供
研究组 & 干预措施
Ravulizumab
Experimental
Participants will receive ravulizumab for up to 26 weeks.
干预措施: Ravulizumab (Drug)
研究者
研究点 (20)
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