NCT06885762尚未招募2 期
Safety and Efficacy of Efgartigimod in Guillain-Barré Syndrome
Zhongming Qiu0 个研究点目标入组 20 人开始时间: 2025年4月13日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Guillain-Barré Syndrome Disability Scale (GBS-DS)
研究概览
简要总结
The goal of this clinical trial is to evaluating the efficacy and safety of efgartigimod in the treatment of Guillain-Barré Syndrome and exploring the immunological mechanisms of efgartigimod therapy in Guillain-Barré Syndrome. The main questions it aims to answer are:
Will efgartigimod improve the symptoms of participants? What medical problems do participants have when using efgartigimod?
Participants will:
On day 1 and day 5 of the treatment period, drug A was administered intravenously.
Keep a diary of their symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older;
- •Meet the diagnostic criteria as specified in the *European Guidelines for the Diagnosis and Treatment of Guillain-Barré Syndrome 2023 Edition*;
- •Onset of GBS symptoms within 2 weeks prior to enrollment;
- •GBS-DS score of 3-5;
- •Written informed consent obtained.
排除标准
- •Patients with GBS symptoms for more than 2 weeks;
- •Known hypersensitivity of the study subject to any component of the investigational drug or any other anti-neonatal Fc receptor (FcRn) agent;
- •Any uncontrolled active infection or severe infection within 8 weeks prior to screening;
- •Patients with other autoimmune diseases, such as Sjögren's syndrome, systemic lupus erythematosus, neuromyelitis optica, myasthenia gravis, multiple sclerosis, etc., requiring treatment with immunosuppressive agents;
- •Vaccination within 4 weeks prior to screening or planned vaccination during the study period;
- •Pregnant or breastfeeding, or planning to become pregnant during the study period, or women of childbearing potential not using effective contraception;
- •Currently participating in another clinical trial of similar investigational agents (FcRn antagonists);
- •Use of the investigational drug within 3 months prior to screening or within five half-lives of the drug (whichever is longer);
- •Patients with a history of malignancy, including malignant thymoma, myeloproliferative or lymphoproliferative disorders, unless considered cured by adequate treatment and without evidence of recurrence for ≥3 years prior to screening. Patients with completely resected non-melanoma skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) or carcinoma in situ of the cervix are eligible at any time;
- •Patients with clinical evidence of other significant severe diseases or who have recently undergone major surgery, which may confound study results or place the patient at undue risk. Patients with severe renal/hepatic impairment may be included.
研究组 & 干预措施
Treatment group
Experimental
干预措施: efgartigimod (Drug)
结局指标
主要结局
Guillain-Barré Syndrome Disability Scale (GBS-DS)
时间窗: 12 weeks.
The mean time to first achieve a GBS-DS score of ≤1 within 12 weeks.
次要结局
未报告次要终点
研究者
Zhongming Qiu
Professor
Xinqiao Hospital of Chongqing
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