An Open-Label Extension Study Evaluating the Safety, Tolerability, PK, Immunogenicity, and Clinical Response of Multiple Doses of IV AK006 in Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allakos Inc.
- 入组人数
- 29
- 试验地点
- 14
- 主要终点
- Incidence of adverse events (AEs), treatment-emergent adverse events, serious adverse events, adverse events of special interest, AEs leading to discontinuation
研究概览
简要总结
An open label extension (OLE) study offered to subjects with Chronic Spontaneous Urticaria that have completed the AK006-001 (NCT06072157) Part C referred to as the Main study portion of the study. Qualified subjects will receive up to four doses of the study drug (AK006) through an intravenous infusion every 4 weeks. There is a 16-week follow up period once all the scheduled infusions have been completed. Subjects will be follow for evaluation of safety, tolerability, PK, immunogenicity, and clinical response.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in Part C of Study AK006-001 (NCT06072157) and completed the randomized, double-blind, placebo-controlled treatment period and the Day 99 Visit.
- •Acceptable demonstration of tolerance to study drug during the AK006-001 study as determined by the investigator.
- •Acceptable demonstration of protocol compliance during the AK006-001 study as determined by the investigator.
- •Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use a highly effective method of contraception with <1% failure rate or abstain from sexual activity from Screening until the end of the study, or for 16 weeks following the last dose of AK006, whichever is longer.
排除标准
- •Pregnant, breastfeeding, or planning to become pregnant while participating in the study.
- •Planned use of an approved or investigational therapy to treat CSU other than a single 2nd- or later-generation H1-AH between 1× and 4× the licensed dose and frequency, during the study.
研究组 & 干预措施
720mg of AK006 IV
Subjects in this arm will receive 4 doses of 720mg of AK006 via intravenous infusion every 4 weeks.
干预措施: AK006 IV (Drug)
结局指标
主要结局
Incidence of adverse events (AEs), treatment-emergent adverse events, serious adverse events, adverse events of special interest, AEs leading to discontinuation
时间窗: Through study completion, approximately 30 weeks
Incidence of clinically significant abnormal laboratory values, ECGs, and vital signs
时间窗: Through study completion, approximately 30 weeks
次要结局
- AK006 serum concentrations(Through study completion, approximately 30 weeks)
- AK006 Anti-drug Antibodies (ADAs)(Through study completion, approximately 30 weeks)