Phase 2 Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen Oral Immunotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 15
- 主要终点
- The Percentage of Subjects Who Tolerate at Least 300 mg (443 mg Cumulative) of Peanut Protein With no More Than Mild Symptoms at the Exit DBPCFC
研究概览
简要总结
This is a multi-center, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oral immunotherapy in peanut allergic individuals.
详细描述
This is a multicenter, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut OIT in peanut allergic individuals. All eligible subjects will receive an escalating dose of CPNA or placebo. Approximately 50 subjects will be randomized 1:1 to peanut OIT or placebo.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Ages 4 through 26 years, inclusive
- •Clinical history of allergy to peanuts or peanut-containing foods
- •Serum IgE to peanut >0.35 kU/L (determined by UniCAP within the past 12 months) and/or a SPT to peanut >3 mm compared to control
- •Experience dose-limiting symptoms at or before the 100mg dose of peanut protein (measured as 200 mg of peanut flour) on abbreviated screening OFC conducted via PRACTALL guidelines
- •Use of birth control by females of child-bearing potential
排除标准
- •History of Cardiovascular disease
- •History of frequent or repeated, severe or life-threatening episodes of anaphylactic shock
- •History of other chronic disease
- •History of eosinophilic gastrointestinal disease
- •Severe asthma
- •Mild or moderate asthma if uncontrolled
- •Use of omalizumab within the past 6 months or current use of other non-traditional forms of allergen immunotherapy
- •Use of beta-blockers(oral), angiotensin-converting enzyme (ACE)
- •Pregnancy, lactation
- •Having the same place of residence as another study subject
- •Participation in an interventional clinical trial 30 days prior to randomization
结局指标
主要结局
The Percentage of Subjects Who Tolerate at Least 300 mg (443 mg Cumulative) of Peanut Protein With no More Than Mild Symptoms at the Exit DBPCFC
时间窗: 6-9 Months
The primary endpoint was the percentage of subjects who achieved desensitization, as determined by tolerating at least 300 mg (443 mg cumulative) of peanut protein at the Exit Double Blind Placebo Controlled Food Challenge (DBPCFC) with no more than mild symptoms (i.e., desensitization responders)
次要结局
- Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC(6-9 months)
- Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC(6-9 months)
- Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC(6-9 months)
- Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC(6-9 months)
- Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline(Baseline, 6-9 months)