A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (The Harmony Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 15
- 主要终点
- 600mg Desensitization in at Least One Qualifying Food
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of ADP101 for oral immunotherapy in food allergic children and adults.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age 4 to 55 (inclusive)
- •Clinical history of allergy to at least 1 of the foods contained in ADP101
- •Experience dose-limiting symptoms at or below the 100-mg dose level to 1 or multiple food sources in ADP101
排除标准
- •Experience dose limiting symptoms at or below the 100 mg challenge dose level to more than 5 food sources contained in ADP101
- •History of severe or life-threatening episode(s) of anaphylaxis or anaphylactic shock within 60 days of screening
- •History of EoE, other eosinophilic gastrointestinal disease, chronic, recurrent or severe GERD, symptoms of dysphagia
- •Severe asthma
- •Mild or moderate asthma, if uncontrolled or difficult to control
- •History of mast cell disorder, including mastocytosis, urticaria pigmentosa or angioedema
- •History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) at risk of becoming unstable or requiring a change in chronic therapeutic regimen e.g. uncontrolled diabetes
- •History of cardiovascular disease, including hypertension requiring > 2 antihypertensive medications
- •History of interstitial lung disease
- •History of celiac disease
- •Active autoimmune disease that has required systemic treatment within 3 months
- •Known malignancy that is progressing or has required active treatment within the past 3 years
- •Known history of HIV, known active hepatitis B infection or known active hepatitis C virus infection
- •Prior/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
- •In the build up phase of non-food immunotherapy
- •Residing at the same address as another subject (e.g. siblings) participating in this or any other OIT study
- •Develops dose-limiting symptoms to placebo during the Screening DBPCFC
- •Any other condition that might preclude safe participation in the study
研究组 & 干预措施
Low dose ADP101
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.
干预措施: Low dose ADP101 (Biological)
High dose ADP101
Participants received ADP101 at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 4500mg ADP101 over the 40 week treatment period. ADP101: Oral formulation mixture of 15 individual food sources from commercially available food flours containing allergenic proteins (almond, cashew, chicken's egg, codfish, cow's milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat) with excipients. Each dose is formulated to contain equal parts by protein weight of each of the 15 individual foods in ADP101.
干预措施: High dose ADP101 (Biological)
Pooled Placebo
Participants received volume-matched placebo at a starting dose of 5mg po daily, with supervised updosing in the clinic as tolerated every 2 weeks to a target dose of 1500mg or 4500mg placebo over the 40 week treatment period. Placebo: Powder containing excipient, aroma and flavor maskers, and coloring agents to achieve similar appearance and total weight as the active, in the same cup packaging as the active.
干预措施: Pooled Placebo (Biological)
结局指标
主要结局
600mg Desensitization in at Least One Qualifying Food
时间窗: 40 Weeks
The proportion of participants in the pediatric ITT population who tolerated the 600mg level of a single qualifying food without dose limiting symptoms at the Week 40 Exit DBPCFC.
次要结局
- 1000mg Desensitization Threshold, Multi-allergic Pediatric ITT Population(40 Weeks)
- 600mg Desensitization Threshold, Multi-allergic Pediatric ITT Population(40 weeks)
- 1000mg Desensitization Threshold in Pediatric ITT Population(40 weeks)