Explorative Open Phase II-study, Food Allergy Suppression Therapy During Protection With Xolair
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Peanut challenge. The peanut challenge can be positive i.e. the study object reacts to peanuts with allergic symptoms or negative i.e. no reaction in two hours after completed challenge.
研究概览
简要总结
Severe peanut allergy is different from other allergic reactions because it can lead to fatal reactions and is an invisible disability. There is no cure today. The purpose of this study is to treat children and adolescents with severe peanut allergy with oral immunotherapy with peanuts under the protection of anti-IgE (immunoglobulin E) antibodies (omalizumab), and thereby inducing tolerance to peanuts. The treatment will be monitored by basophil cell stimulation (CD-sens).
详细描述
Oral immunotherapy (OIT), where the food protein is consumed in increasing amounts, have been studied with good results, but allergic reactions has been a major problem. Anti-IgE antibodies (omalizumab) block allergy antibodies so that the allergic reaction is absent. A new test in which basophil cells stimulated with allergen in vitro, CD-sens, showing cell sensitivity, correlates well to peanut challenges.
Twenty children/adolescents, 12 to 22 years, with severe peanut allergy will be treated with omalizumab and the effect evaluated with CD-sens. If the CD-sens is negative a peanut challenge will be performed. If the challenge is negative the OIT will start: 1, 2, 4, 8 g peanuts/day in two-week intervals followed by a maintenance dose of 10 g peanuts/day while continuing treatment with omalizumab. If the CD-sens is still negative the withdrawal of omalizumab will start by halving the dose in several steps.
The study is independent of pharmaceutical companies. Omalizumab is dosed according to body mass and the amount of total IgE antibodies and therefore every individual has an individual study duration. In average the duration of the study is estimated to 52 weeks +/-40/20 weeks. Inclusion in the study is expected to last for the 2 coming years.
A treatment without serious side effects for those with severe food allergies would give a great benefit with reduced anxiety and fear, but also major health economic benefits in the form of fewer hospitalizations, sick leave, and to a greater extent completed school and education.
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
- 12 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IgE to peanut, Ara h 1, Ara h 2 and Ara h 3
- •IgE to an airborne allergen i.e. cat, dog, horse, birch, grass etc.
- •Clinical allergic reactions to peanut the last 5 years
- •Positive conjunctival challenge to the selected airborne allergen
- •Positive CD-sens to peanut and the selected airborne allergen
- •IgE according to the recommendations of the manufacturer
- •Written consent
排除标准
- •No severe diseases like renal failure, hart disease, immunodeficiency, diabetes or other severe chronic diseases
- •Pregnancy
- •No previous hypersensitivity reactions to sucrose, histidine, polysorbat 20 or omalizumab
研究组 & 干预措施
Omalizumab
Omalizumab is given to protect the study object from severe allergic reactions while they are going through oral immunotherapy with peanuts. There wïll be only one arm. The study objects are their own controls by also having allergy to airborne allergens. The dose is calculated by the study objects body mass and number of total IgE antibodies.
干预措施: Omalizumab (Drug)
结局指标
主要结局
Peanut challenge. The peanut challenge can be positive i.e. the study object reacts to peanuts with allergic symptoms or negative i.e. no reaction in two hours after completed challenge.
时间窗: The participants will be followed for the duration of Xolair treatment and oral immunotherapy, an expected average of 1 year
次要结局
未报告次要终点
研究者
Caroline Nilsson
MD, PhD
Karolinska Institutet