Phase 2 Study of Omalizumab in Oral Peanut Desensitization
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo
研究概览
简要总结
The investigators will perform a double blind, placebo controlled clinical trial with Xolair (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut allergy. The investigators will determine if pretreatment with anti-IgE mAb (Xolair/omalizumab) can greatly reduce allergic reactions and allow for faster and safer desensitization.
详细描述
36 subjects will receive Xolair, and 8 subjects will receive placebo. The study will occur at 4 sites: Boston Children's Hospital, Children's Hospital of Philadelphia, Stanford University and Lurie Children's Hospital.
Patients will be pre-treated with Xolair or placebo before rapid oral peanut desensitization. Patients will continue to receive Xolair during the 8 subsequent weeks of desensitization, receiving their final dose of Xolair one week after reaching the highest tolerated dose of peanut.
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
- 7 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe peanut allergy-sensitive subjects between the ages of 7 to 25 years old.
- •Sensitivity to peanut allergen will be documented by a positive skin prick test result (6 mm diameter wheal or greater)
- •ImmunoCAP IgE level to peanut > 10 kU/L.
- •Sensitivity to peanut allergen based on a double-blind placebo-controlled oral food challenge (DBPCFC) at maximum of cumulative 175 mg of peanut protein dose.
排除标准
- •Subjects with a total IgE at screening of < 50 kU/L > 2,000 kU/L.
- •Positive reaction to the placebo on DBPCFC.
- •Previous reaction to omalizumab.
- •Subjects having a history of severe anaphylaxis to peanut requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma, or gastrointestinal or gastroesophageal disease.
研究组 & 干预措施
omalizumab group
Patients will receive omalizumab.
干预措施: Omalizumab (Drug)
placebo
Patients will receive placebo.
干预措施: placebo (Drug)
结局指标
主要结局
Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo
时间窗: 6 weeks after last dose of omalizumab/placebo
次要结局
- Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo(12 weeks after last dose of omalizumab/placebo)
研究者
Lynda Schneider
Professor, Harvard Medical School
Boston Children's Hospital