Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) Follow-on Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 388
- 试验地点
- 129
- 主要终点
- Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE)
研究概览
简要总结
The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101 through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed the ARC003 study.
详细描述
This is an international, multicenter, open-label, 2-arm follow-on study of the safety, tolerability, and efficacy of AR101 in peanut-allergic individuals who have completed the ARC003 study. This study will explore alternative dosing regimens during extended maintenance with AR101.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the ARC003 study
- •Written informed consent and/or assent from subjects/guardians as appropriate
- •Use of effective birth control by sexually active female subjects of child-bearing potential
排除标准
- •Early discontinuation from the ARC003 study
- •Meets any longitudinally applicable ARC003 study exclusion criteria
- •(Group 2 only) Failure to tolerate ≥ 443 mg cumulative of peanut protein with no or mild symptoms in the ARC003 study Exit DBPCFC
- •Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
结局指标
主要结局
Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE)
时间窗: Up to 126 weeks
Percentage of subjects ages 4-17 with at-least 1 TEAE, including serious adverse events, during the overall study period. The percentage of subjects reporting at least 1 TEAE by maximum reported severity is also presented using the 5-point CTCAE severity grading scale. All safety evaluations were conducted using the safety population (all subjects who received at least 1 dose of AR101 during ARC004), age 4-17 years. Safety data are presented for group 1 (former placebo) and Group 2 data are divided into columns for cohort 1 (QD), cohort 2 (overall), cohort 3A (QD), and cohorts 3B and 3C (overall).
次要结局
- Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge)(Up to 126 weeks)