A Phase 1b Study to Evaluate the Safety, Tolerability and Drug-Drug Interactions of ANX005 and Intravenous Immunoglobulin (IVIg) in Subjects With Guillain Barré Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Safety and tolerability of ANX005 when administered in combination with IVIg: incidence of TEAEs, SAEs, AE's
研究概览
简要总结
This study is a multi center, open-label, study of ANX005 in combination with IVIg in subjects diagnosed with GBS.
详细描述
The study will enroll approximately 12 subjects into one cohort, with subjects receiving 75 mg/kg of ANX005, a dose shown to be safe and well-tolerated as monotherapy and that provides a meaningful level of exposure to be tested in combination with IVIg. Dosing of IVIg will be administered as is the current standard of care (0.4 g/kg/day x 5 days) and ANX005 will be administered concurrently, beginning on Day 1 or 2 of the treatment period. Subjects will be followed for 6 months after treatment for observation and evaluation.
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
- •Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for Guillain Barré Syndrome
- •Onset of GBS-related weakness ≤14 days prior to infusion
- •GBS-DS score of 3, 4, or 5
排除标准
- •Clinically significant findings that may interfere with the conduct of the study or the interpretation of the data
- •Be at risk of suicide or self-harm
- •Received previous treatment with plasma exchange for GBS
- •Any diagnosis of a variant of GBS
- •Have a history of anaphylaxis or severe systemic response to immunoglobulin
- •Documented, clinically significant, pre-existing polyneuropathy from another cause
- •Clinically significant intercurrent illness, medical condition, or medical history
- •History of chronic use of steroid or immunosuppressant medication
- •Active alcohol, drug, or substance abuse
- •Females who are pregnant, breast feeding, or unable or unwilling to use highly effective methods of contraception throughout the study
研究组 & 干预措施
Open Label Treatment Arm
One (1) dose of ANX005, 75 mg/kg, will be administered IV. IVIg, 0.4 g/kg, will be administered for 5 consecutive Days.
干预措施: ANX005 (Drug)
Open Label Treatment Arm
One (1) dose of ANX005, 75 mg/kg, will be administered IV. IVIg, 0.4 g/kg, will be administered for 5 consecutive Days.
干预措施: Intravenous immunoglobulin (Drug)
结局指标
主要结局
Safety and tolerability of ANX005 when administered in combination with IVIg: incidence of TEAEs, SAEs, AE's
时间窗: 6 months
As measured by incidence of TEAEs, SAEs, AE's related to ANX005, SAE's related to ANX005, Grade 3 or higher AEs, Grade 3 or higher AEs related to ANX005, AEs leading to study or treatment discontinuation.
次要结局
- Values and change from baseline in Guillain-Barré Syndrome Disability Score (GBS-DS) by visit(6 months)
- Pharmacodynamics of ANX005 when administered in combination with IVIg(4 months)
- Pharmacokinetics of ANX005 when administered in combination with IVIg(3 months)