NCT03337542已完成3 期
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children, Active Treatment Arm Open-Label Extension Study (RAMSES OLE)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 120
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)
研究概览
简要总结
This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.
详细描述
This is a Phase 3, multi-center, North American, open-label, long-term, safety extension study for eligible subjects who received AR101 therapy in the ARC007 trial (NCT03126227) and completed the study.
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
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received AR101 in study ARC007
- •Completed the ARC007 study
- •Use of effective birth control by sexually active female subjects of childbearing potential
排除标准
- •Developed a clinically significant change in health status during the ARC007 study which in the opinion of the investigator would make the subject unsuitable for participation in this study.
- •Receiving a prohibited medication or anticipated use of a prohibited medication [e.g., angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calcium channel blockers], any monoclonal antibody, any investigational peanut immunotherapy, or any other immunomodulatory therapy.
- •Currently in the build-up phase of immunotherapy for any nonfood allergen.
- •Currently participating in any other interventional clinical study outside of the ARC007 study that was just completed.
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)
时间窗: Approximately 6 months
Number of participants with treatment-emergent adverse events including serious adverse events during the overall study period (safety and tolerability)
次要结局
- Number of Participants With of Anaphylaxis as Defined in the Protocol(Approximately 6 months)
- Percentage of Subjects With Chronic/Recurrent GI Adverse Events Resolving Before 2, Between 2 and 4, Between 4 and 12, and ≥ 12 Weeks After Discontinuation of Dosing(Approximately 6 months)
- Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events(Approximately 6 months)
- Number of Participants With Allergic Hypersensitivity Adverse Events(Approximately 6 months)
- Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods(Approximately 6 months)
- Number of Participants With Adverse Events That Led to Early Withdrawal(Approximately 6 months)
- Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events(Approximately 6 months)
- Number of Participants With Epinephrine Use as Rescue Medication(Approximately 6 months)
- Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11(Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months))
- Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17(Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months))
研究者
研究点 (120)
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