NCT04701164已完成3 期
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ANX005 in Subjects With Guillain-Barré Syndrome
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
- 242
- 试验地点
- 11
- 主要终点
- GBS Disability Score (GBS-DS) at Week 8
研究概览
简要总结
This study is intended to evaluate the efficacy and safety of ANX005 administered by intravenous (IV) infusion to participants recently diagnosed with Guillain-Barré Syndrome (GBS). The total duration of study participation is approximately 6 months.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for Guillain-Barré Syndrome.
- •Onset of GBS-related weakness ≤10 days prior to start of infusion.
- •GBS-DS score of 3,4, or 5 at screening and at Day 1 prior to infusion.
排除标准
- •Clinically significant findings on the screening electrocardiogram (ECG), laboratory test results, or physical examination that are not specific to GBS that may interfere with the conduct of the study, the interpretation of the data, or increase the participant's risk.
- •Body weight <30 kilograms (kg) or >150 kg at screening.
- •Unresponsive (inexcitable) nerve conduction study results in all nerves tested during screening.
- •Previous or intended treatment with either plasma exchange or intravenous immunoglobulin for GBS.
- •Diagnosis of a variant of GBS, including Miller Fisher syndrome, Bickerstaff's encephalitis, and overlap syndromes.
- •History of prior episode of GBS.
- •GBS-related weakness that improved since symptom onset, including an improvement between screening and Day 1 (baseline).
研究组 & 干预措施
Placebo Group
Placebo Comparator
Participants will receive a single IV infusion of placebo on Day 1.
干预措施: Placebo (Drug)
ANX005 Treatment Group - Dose 2
Experimental
Participants will receive a single IV infusion of ANX005 (Dose 2) on Day 1.
干预措施: ANX005 (Drug)
ANX005 Treatment Group - Dose 1
Experimental
Participants will receive a single IV infusion of ANX005 (Dose 1) on Day 1.
干预措施: ANX005 (Drug)
结局指标
主要结局
GBS Disability Score (GBS-DS) at Week 8
时间窗: Week 8
Number of Participants with Adverse Events
时间窗: Through Month 6
Number participants recently diagnosed with GBS who experience adverse events.
次要结局
- Medical Research Council (MRC) Sum Score at Week 8(Week 8)
- MRC Sum Score at Day 8(Day 8)
- Duration (Days) of Ventilation Support Over 26 Weeks(26 weeks)
- GBS Disability Score (GBS-DS)(Week 26)
- Number of Participants Requiring Intensive Care Unit Stay(26 weeks)
- Duration (Days) of Intensive Care Unit Stays(26 weeks)
- Patient Global Impression of Change Scores(Week 8 and Week 26)
研究者
研究点 (11)
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