An Open-label, Single-dose, Pharmacokinetic Study to Evaluate IV Eptinezumab in Children and Adolescents With Migraine, Followed by an Optional, Multiple-dose, Open-label Extension Period
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 9
- 主要终点
- Area under curve (AUC) (0-infinity) eptinezumab
研究概览
简要总结
The purpose of the study is to investigate how the body absorbs, distributes, and get rid of eptinezumab when given directly into a vein.
详细描述
This is an interventional, open-label pharmacokinetic study with eptinezumab, consisting of a single-dose, 20-week main study period (Part A) and an optional 44-week multiple-dose extension period (Part B).
The main study period includes a single IV infusion of eptinezumab. The optional extension period includes 3 additional eptinezumab infusions 12 weeks apart (reflecting recommended dosing interval in adults), for a total of up to 4 infusions over the course of the study.
At least 32 patients with migraine will be enrolled: 16 patients aged 6 to 11 years, and 16 patients aged 12 to 17 years, inclusive.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has a diagnosis of migraine with or without aura according to international classification of headache disorders (ICHD)-3 (in the opinion of the investigator) for ≥6 months prior to the Screening Visit and has a frequency of migraine ≥4 migraine days per month for at least 3 months prior to the Screening Visit.
排除标准
- •The patient has been exposed to any monoclonal antibody treatment (including exposure in a study) <6 months prior to the Screening Visit.
- •Other in- and exclusion criteria may apply
研究组 & 干预措施
Eptinezumab
干预措施: Eptinezumab (Drug)
结局指标
主要结局
Area under curve (AUC) (0-infinity) eptinezumab
时间窗: From dosing to week 20
Area under the plasma concentration curve for eptinezumab from zero to infinity
Cmax eptinezumab
时间窗: From dosing to week 20
Maximum observed plasma concentration of eptinezumab
次要结局
- Volume of distribution (Vz)(From dosing to week 20)
- Development of anti-eptinezumab antibodies (ADA)(From screening to week 12)
- Characterization of anti-eptinezumab antibodies for neutralizing activity (NAb)(From screening to week 12)
- Clearance (CL)(From dosing to week 20)