NCT04620811已完成3 期
A Phase 3, Multicenter, Open-Label, Extension Study to Evaluate the Efficacy and Safety of AK002 in Patients That Were Previously Enrolled in AK002-016 or AK002-012 Studies and Have Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allakos Inc.
- 入组人数
- 159
- 试验地点
- 38
- 主要终点
- The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0
研究概览
简要总结
This is a Phase 3, open-label, extension study to assess the long term efficacy and safety of lirentelimab given monthly.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent.
- •Completed Study AK002-016, defined as having received 6 infusions of study drug and followed through Day 176 (±3) or completed Study AK002-012, defined as having received the cohort-appropriate amount of doses and followed for 5 months after last dose of study drug.
- •If patient is on pre-existing dietary restrictions, willingness to maintain those restrictions, throughout the study.
- •Able and willing to comply with all study procedures.
- •Female patients must be either post-menopausal for at least 1 year or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity until the end of the study, or for 120 days following the last dose of study drug, whichever is longer.
- •Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant at any time during study participation.
排除标准
- •Known hypersensitivity to any constituent of the study drug.
- •Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk.
- •Planned or expected vaccination with live attenuated vaccines during the Treatment Period, or vaccination expected within 5 half-lives (4 months) of AK002 administration.
- •Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
- •Any other reason that, in the opinion of the Investigator or Medical Monitor, makes the patient unsuitable for enrollment.
研究组 & 干预措施
3.0 mg/kg of Lirentelimab (AK002)
Experimental
Subjects in this arm will receive up to 18 monthly doses (3mg/kg) of lirentelimab (AK002)
干预措施: lirentelimab (Drug)
结局指标
主要结局
The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0
时间窗: Through study completion, up to 21 months
Adverse events assessed using the CTCAE version 5.0.
次要结局
未报告次要终点
研究者
研究点 (38)
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