A Continuation Study of Latozinemab in Participants With Neurodegenerative Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Alector Inc.
- 入组人数
- 17
- 试验地点
- 18
- 主要终点
- Duration of treatment with latozinemab
研究概览
简要总结
Continuation study to provide continued access to latozinemab for participants who have previously participated in a latozinemab study
详细描述
This is an open-label continuation study to provide access and assess the safety and tolerability of latozinemab in participants who have completed participation in their parent latozinemab study.
All participants will receive open-label latozinemab at a dose of 60/mg/kg, every 4 weeks (q4w).
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
盲法说明
This is an open label continuation study
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
- •Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).
- •Has successfully completed participation in their parent latozinemab study.
- •Female participants must be nonpregnant and nonlactating.
- •Male participants must agree to acceptable contraception use.
排除标准
- •Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
- •Clinically significant heart disease, liver disease or kidney disease. History or evidence of clinically significant brain disease other than FTD.
研究组 & 干预措施
Open Label
Latozinemab (AL001) administered by IV infusion over 60 minutes, q4w
干预措施: Latozinemab (Drug)
结局指标
主要结局
Duration of treatment with latozinemab
时间窗: Through study completion, up to 190 weeks
Duration of treatment with latozinemab
Number of participants receiving latozinemab
时间窗: Through study completion, up to 190 weeks
Number of participants receiving latozinemab
次要结局
- Incident of adverse events (AEs) and serious adverse events (SAEs)(Through study completion, up to 190 weeks)
- Nature and severity of AEs and SAEs(Through study completion, up to 190 weeks)
- Incidence of ADAs to latozinemab(Through study completion, up to 190 weeks)