NCT05737160已完成3 期
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study of Telitacicept in Patients With Generalized Myasthenia Gravis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 51
- 主要终点
- Change from baseline in MG-ADL
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Telitacicept in the treatment of patients with generalized myasthenia gravis.
详细描述
This study consists of a screening period, a double-blind treatment period (part A) and an open-label treatment period (part B). After screening, eligible subjects will be randomized in a 1: 1 ratio to receive either subcutaneous Telitacicept 240 mg or placebo once a week for 24 doses (part A). Completing part A, subjects will automatically enter part B. In part B, all subjects will receive weekly subcutaneous Telitacicept 240 mg for 24 weeks.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent provided;
- •Male or female patients aged 18-80 years;
- •Diagnosis with generalized myasthenia gravis;
- •MGFA Class II, III, or IVa;
- •AChR-Ab or MuSK-Ab positive;
- •A total MG-ADL score of ≥ 6 with less than 50% of the total score due to ocular symptoms;
- •QMG ≥ 8, with ≥ 4 items score at least 2;
- •Have been on a stable MG SoC regimen.
排除标准
- •Patients with autoimmune diseases other than MG;
- •Abnormal laboratory results；
- •Use of immunosuppressants other than standard therapy within 1 month before randomization;
- •Use of biologic agents targeting therapy, such as Rituximab or complement C5 inhibitors, within 6 months before randomization;
- •Use of neonatal Fc receptor (FcRn) antagonists, intravenous immunoglobulin (IVIg), or plasmapheresis within 2 months before randomization;
- •Significant cardiovascular disease, liver, kidney, respiratory, endocrine or hematologic disease, or other medical conditions that, in the opinion of the investigator, would preclude the subject's participation in the study or require hospitalization during the study;
- •Acute or chronic infection requiring treatment;
- •Current active hepatitis;
- •HIV antibody positive;
- •Patients currently suffering from thymoma-associated immunodeficiency syndrome (Good's syndrome) or who underwent thymectomy within 6 months before screening;
- •Received or plan to receive any live vaccine within 3 months prior to randomization;
- •Patients with malignant tumors;
- •Allergy to biological products of human origin;
- •Participation in any clinical trial 28 days prior to randomization or within 5 times the half-life of an investigational drug (whichever is longer);
- •Pregnant or lactating women, and those intending to become pregnant during the trial;
- •Patients considered unsuitable by the investigator to participate in the trial (e.g., patients with severe mental disorders);
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Telitacicept
Experimental
Participants will receive subcutaneous Telitacicept 240 mg once a week for a total of 48 doses in addition to MG SoC.
干预措施: Telitacicept (Biological)
Placebo
Placebo Comparator
Participants will receive subcutaneous placebo once a week for a total of 24 doses (part A) and then weekly subcutaneous Telitacicept 240 mg for 24 doses (part B) in addition to MG SoC.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in MG-ADL
时间窗: Week 24
The MG-ADL is an 8-item patient-reported scale that measures MG symptoms and functional status. Each item ranges from 0 to 3 for a total score range of 0 to 24.
次要结局
- Change from baseline in QMG(Weeks 12, 24, 36, 48)
- Change from baseline in MG-ADL(Weeks12, 36, 48)
- Proportion of subjects with ≥ 3 points reduction from baseline in MG-ADL(Weeks 24, 48)
- Proportion of subjects with a decrease of ≥ 5 points from baseline in QMG(Weeks 24, 48)
研究者
研究点 (51)
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相关资讯
FDA Approves Nipocalimab for Myasthenia Gravis as Pipeline Advances with 20+ Novel Therapies- The FDA approved nipocalimab (Imaavy) in May 2025 as the first therapy targeting the underlying cause of generalized myasthenia gravis in patients aged 12 and older with specific antibodies.
- Over 20 companies are developing 22+ novel myasthenia gravis therapies, including promising candidates like Descartes-08, Telitacicept, and batoclimab showing sustained efficacy in Phase 2b and Phase 3 trials.
- Recent clinical developments include Cartesian Therapeutics reporting 12-month sustained improvement with Descartes-08 and RemeGen sharing positive Phase 3 results for Telitacicept at the 2025 AAN Annual Meeting.last yearRemeGen's Telitacicept Shows Remarkable 98% Response Rate in Phase 3 Trial for Generalized Myasthenia Gravis- Telitacicept demonstrated a 98.1% response rate in reducing MG-ADL scores by ≥3 points at Week 24, potentially positioning it as best-in-class among treatments for generalized myasthenia gravis.
- The novel fusion protein targeting both BLyS and APRIL showed significant improvements in both patient-reported outcomes (MG-ADL) and objective measures (QMG), with benefits emerging as early as 4 weeks after treatment initiation.
- RemeGen's BLA for Telitacicept has been accepted by China's regulatory authorities with approval expected in Q2 2025, while a global Phase 3 trial is advancing to validate efficacy in a broader patient population.last year