Treatment With Omalizumab in Food Allergic Children (TOFAC)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in challenge threshold (mg food protein tolerated by oral intake)
研究概览
简要总结
Food allergy is a common disease in childhood affecting up to 8% of children in Westernized countries. About 30 percent of children with food allergies are allergic to more than one food, most often milk, egg, wheat, peanut and tree nut. Peanut and hazelnut are common triggers of severe and potentially fatal food-induced anaphylactic reactions. Currently, there is no curative treatment for food allergy. Novel therapies for this potentially life-threatening condition are therefore much needed.
详细描述
Randomized, double-blind, placebo-controlled study to study the effect of Omalizumab on children with food allergy.
Primary endpoint: Change in challenge threshold after 3 months of treatment in patients treated with Omalizumab versus placebo.
Secondary endpoints: Change in challenge threshold at 6 months. Change in Skin Prick Test (SPT), serum markers for allergy (specific IgE, IgG4, BAT (basofil activation test)), severity of comorbidity, and quality of life from at 3 and 6 months. Change in treshold within and between the groups.
The investigator's hypothesis is that increased Omalizumab dose and/or a longer treatment period will increase food allergy threshold.
Within the groups:
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)
盲法说明
The syringes are filled and masked with opaque material of unblinded personnel who do not have patient contact.
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children between 6 and 18 years
- •a clinical diagnosis of food allergy to ≥1 food allergen
- •a positive SPT (mean wheal diameter > 3 mm)
- •s-IgE > 0.35 kIU/l
- •a positive food challenge with a threshold at or below 300 mg of protein (443 mg cumulative) in a double blind placebo controlled food challenge (DBPCFC).
- •(If the patient is allergic to more than one food allergen, the allergen with the highest probability of fulfilling the inclusion criteria (based on case history, level of s-IgE and when available challenge results within the last year) will be used).
排除标准
- •t-IgE >1500 kIU/L.
- •Significant co-morbidity that might compromise the patient's safety or study outcomes.
- •Pregnancy or nursing in the adolescents. Women of childbearing potential have to use safe contraception (intrauterine device or hormonal contraception if sexual active). Safe contraception has to be used during the whole trial period and half a year after the last dose of the trial medicine has been taken.
- •Ongoing treatment with antihistamine or drugs with antihistaminic properties that cannot be paused during the study
- •Ongoing treatment with drugs that may impair safety during food challenge e.g. β-blockers or ACE-inhibitors that cannot be paused during the study
- •Ongoing treatment with oral glucocorticoids/Omalizumab/allergen immunotherapy (AIT)
- •Alcohol abuse, abuse of opioids or other drugs in adolescents
- •Treated with Omalizumab until ½ years before the study
- •Patients/parents who are not supposed to be able to meet the requirements in the protocol
- •Patients/parents who are physically or mentally unable to consent
- •Patients who have reduced liver function or kidney function
研究组 & 干预措施
Omalizumab
Omalizumab is a sterile solution in a prefilled syring for subcutaneous injection. The syrings contains 75 mg or 150 mg omalizumab.
75 patients will have Omalizumab in doses depending of body weight and IgE every 2. or 4. week for 6 month Omalizumab is administered subcutaneously
干预措施: Omalizumab (Drug)
Placebo
Placebo contains sodium chloride 0,9 % in a prefilled syring for subcutaneous injection.
25 patients will have placebo depending of the body weight and IgE every 2. or 4. week in 3 month. They will subsequently get Omalizumab for 3 month if nonresponders.
Placebo is administered subcutaneously
干预措施: Placebo (Other)
结局指标
主要结局
Change in challenge threshold (mg food protein tolerated by oral intake)
时间窗: 0-3 months
Change in challenge threshold after 3 months of treatment in patients treated with Omalizumab versus placebo
次要结局
- Change in quality of life (validated questionnaire - food allergy quality of life questionnaire (FAQLQ))(0-6 months)
- Change in levels of serum markers for food allergy (IgE (kIU/L), IgG4 (kIU))(0-6 months)
- Change in skin prick test size (mm)(0-6 months)
- Change in severity of co-morbidity (atopic dermatitis, asthma, allergic rhintitis using clinical severity scores)(0-6 months)
- Change in levels of serum markers for food allergy BAT test (CD-sens))(0-6 months)
研究者
Carsten Bindslev-Jensen
Professor, M.D., Dr.Med. Ph.D,
Odense University Hospital