An Open-Label Extension Study Evaluating the Safety and Efficacy of ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (The Encore Study)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 14
- 主要终点
- Long-term safety and tolerability of ADP101
研究概览
简要总结
This is an open-label, safety extension study for participants who participated in the Harmony study (protocol ADP101-MA-01).
详细描述
This study is enrolling participants by invitation only. This is a multicenter, open-label, long-term extension study of the safety and efficacy of ADP101 for oral immunotherapy in food allergic children and adults who completed the Harmony study (protocol ADP101-MA-01).
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 57 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have completed the ADP101-MA-01 (The Harmony Study) and been compliant with study drug per protocol
排除标准
- •History of or current EoE, other eosinophilic gastrointestinal disease, chronic, recurrent or severe GERD, symptoms of dysphagia
- •Hypersensitivity to epinephrine or any of the excipients in ADP101
- •Prior or concurrent therapies as follows:
- •beta-blockers, ACE inhibitors, ARBs or calcium channel blockers
- •regular steroid medication use
- •therapeutic antibody treatment currently or within the previous 6 months
- •any food immunotherapy currently or within the previous 12 weeks, except ADP101
- •investigational agents other than ADP101
- •in the build up phase of non-food immunotherapy
- •Any other condition that might preclude safe participation in the study
研究组 & 干预措施
Treatment Options 1, 2, 3, 4, 5
Participants will fall into 1 of 5 treatment options dependent on the treatment received (ADP101 or placebo) during the parent study and their tolerance of the treatment regimen during the parent study.
干预措施: ADP101 (Biological)
结局指标
主要结局
Long-term safety and tolerability of ADP101
时间窗: Through study completion, approximately 4-6 years
Incidence of adverse events including serious adverse events during the study period.
次要结局
- Food Allergy Desensitization(Week 40)