NCT05243719终止1 期
An Open-Label Extension Study Evaluating the Safety and Efficacy of ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (The Encore Study)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 15
- 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
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)
研究者
研究点 (15)
Loading locations...
相似试验
已完成
3 期
An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic MedicationSchizophreniaNCT05741528Otsuka Pharmaceutical Development & Commercialization, Inc.75
终止
3 期
Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum DisordersAutism Spectrum DisordersNCT01706523Seaside Therapeutics, Inc.165
已完成
2 期
Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211)Amyotrophic Lateral SclerosisNCT00931944Knopp Biosciences74
进行中（未招募）
不适用
Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With EpilepsyMedDRA version: 17.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersEpilepsyEUCTR2014-004375-23-Outside-EU/EEACB BIOSCIENCES, Inc.45
已完成
3 期
An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's DiseaseAlzheimer's DiseaseNCT00219232Novartis868