NCT07622342尚未招募2 期
A Phase II, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of SHR-2173 in Patients With Generalized Myasthenia Gravis
Guangdong Hengrui Pharmaceutical Co., Ltd2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
研究概览
简要总结
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of SHR-2173 compared to placebo as an add-on therapy to standard of care (SOC) for the treatment of generalized myasthenia gravis (gMG). The study consists of a 4-week screening period, a 24-week treatment period, and a 12-week safety follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants aged 18-75 years, confirmed diagnosis of generalized myasthenia gravis (gMG) (Myasthenia Gravis Foundation of America [MGFA] class II-IV).
- •Positive for anti-AChR antibody or anti-MuSK antibody.
- •MG-ADL total score ≥5 at screening and baseline, with >50% of the score attributable to non-ocular items.
- •QMG score ≥11 at screening and baseline.
- •Maintenance on stable standard of care (SOC) therapy.
- •No contraindication to at least one rescue therapy: IVIg or PLEX.
- •Provided written informed consent (ICF) after full understanding of the study content, procedures, and potential adverse reactions.
- •Female subjects with fertility or male participants whose partners are women of childbearing age must avoid donating sperm/eggs from the date of signing the ICF until 12 weeks after the last study medication, and agree to take contraceptive measures as specified in the protocol
排除标准
- •Presence of any of the following medical histories or comorbidities:
- •Any untreated thymic epithelial tumor, mediastinal germ cell tumor, or other malignant mediastinal mass; or any thymic cyst or other mass requiring immediate intervention per investigator judgment;
- •Previous history of thymic tumor not meeting protocol requirements;
- •Myasthenic crisis (MGFA Class V) within 3 months prior to randomization;
- •Any known disease other than gMG that may interfere with study procedures and assessments;
- •A history of progressive multifocal leukoencephalopathy (PML);
- •A history of body irradiation or organ transplantation.
- •Use of any of the following drugs/treatments or participation in a clinical study:
- •Prior treatment with CAR-T or other cellular therapy, or T-cell engager (TCE) therapy;
- •Anti-CD20 monoclonal antibody within 6 months prior to randomization; other B-cell or plasma cell-depleting therapy within 6-12 months prior to randomization;
- •Alkylating agent within 12 weeks prior to randomization;
- •Any biologic for MG treatment within 12 weeks prior to randomization;
- •Neonatal Fc receptor antagonist therapy within 8 weeks prior to randomization;
- •Janus kinase (JAK), Bruton tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2) inhibitor within 12 weeks prior to randomization;
- •IVIg, subcutaneous immunoglobulin, or PLEX therapy within 4 weeks prior to randomization;
- •Live/attenuated live vaccine within 4 weeks prior to randomization, or planned vaccination during the study.
- •A history of malignancy within 5 years prior to screening;
- •Infection-related medical history and examinations:
- •A history of herpes zoster meeting any of the following: 1) A history of disseminated herpes zoster, herpes zoster encephalitis, or ocular herpes zoster involving the retina; 2) Recurrent herpes zoster with 2 or more episodes within 2 years; 3) Herpes zoster infection not fully resolved within 12 weeks prior to screening;
- •A history of tuberculosis (TB) or latent TB infection;
- •A known history of primary immunodeficiency, splenectomy, or any underlying condition predisposing to infection;
- •A history of recurrent infections requiring hospitalization and intravenous antibiotics;
- •Any infection requiring hospitalization and/or intravenous antimicrobial therapy within 8 weeks prior to randomization, or any infection requiring oral antimicrobial therapy within 2 weeks prior to randomization;
- •Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody, treponemal pallidum antibody, or human immunodeficiency virus (HIV) antibody; for patients with HBsAg-negative but hepatitis B core antibody (HBcAb)-positive, regardless of the status of hepatitis B surface antibody (HBsAb), HBV-DNA testing is required to confirm their condition, with HBV-DNA-positive patients excluded and HBV-DNA-negative patients eligible to participate in the study.
- •General situation:
- •Pregnant or lactating females;
- •A history of alcohol abuse or illicit drug abuse within 1 year prior to screening;
- •A history of allergic diathesis, or known hypersensitivity/intolerance to any component of the investigational product;
- •Major surgery within 3 months prior to the screening, or planned major surgery during the study;
- •Any condition that, in the investigator's judgment, may affect evaluation of study drug safety and efficacy, or any other condition that renders the subject ineligible.
研究者
研究点 (2)
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