Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) Safety Follow-On Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 15
- 主要终点
- Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months
研究概览
简要总结
This is a multi-center, open-label, follow-on study to gather additional information on the safety and tolerability of oral desensitization with CPNA in the subjects who participated in ARC001.
详细描述
This phase 2, open-label, follow-on, multicenter study was designed to gather additional information on the safety, tolerability, and efficacy of oral desensitization with AR101 in subjects who participated in study ARC001 (NCT01987817) as follows:
- Group 1 (ARC001 placebo): Subjects who received placebo in study ARC001
- Group 2 (ARC001 AR101): Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001
All subjects will receive daily oral dosing of peanut OIT (oral immunotherapy) in the form of Characterized Peanut Allergen (CPNA).
Study Duration - 12-90 weeks before reaching the Extended Maintenance Phase. All Subjects may continue Extended Maintenance Phase until CPNA becomes commercially available or the study is terminated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of ARC001 study
- •No change in the status of any longitudinally applicable ARC001 inclusion criteria
排除标准
- •Early termination from ARC001
- •Failure to tolerate 300 mg of peanut protein in the ARC001 exit food challenge
- •A lapse in dosing of more than 10 days from completion of ARC001
- •Change in the status of any longitudinally applicable ARC001 exclusion criteria
结局指标
主要结局
Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months
时间窗: Up to 90 weeks
TEAEs are any event starting during or after the active treatment period. If a subject has multiple occurrences of TEAEs, the subject is presented once in the respective subject count (n).
次要结局
- The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC(Up to 36 weeks)
- The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC.(Up to 60 weeks.)
- Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein(Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance))
- Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated(Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance))
- Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance(Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks))
- Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance(Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks))
- Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance(Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks))
- Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC(Up to 36 weeks for up-dosing)
- Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC(Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance))
- Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance.(Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks))