Oral Food Challenge After One to Two Doses of Omalizumab Treatment for Food Allergy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving pre-specified thresholds without dose-limiting symptoms during first post-treatment oral food challenge.
研究概览
简要总结
The goal of this clinical trial is to learn how quickly omalizumab begins to work in people with food allergy. The main question it aims to answer is:
- Does omalizumab begin to work as early as 2 to 4 weeks after after starting treatment in people with food allergy?
Researchers will compare each participant's food challenge results at baseline before starting omalizumab, 2 to 4 weeks after starting omalizumab, and 4 to 6 months after starting omalizumab treatment.
Participants will:
- Have a baseline food challenge before starting omalizumab.
- Start omalizumab treatment as prescribed by the participant's doctor as part of regular clinical care.
- Have food challenges 2 to 4 weeks after starting omalizumab and again 4 to 6 months after starting omalizumab.
- Have skin prick testing and blood tests at study visits.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 1 Year 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Age 1 to 30 years.
- Patients with diagnosed food allergy to at least one of the following foods (milk, egg, wheat, peanut, cashew, or walnut) who were prescribed omalizumab for food allergy in the clinical setting at the Johns Hopkins pediatric or adult allergy clinic.
- Positive food-specific IgE (≥2.0 kUA/L) to the relevant food OR a positive skin-prick test with a wheal ≥4 mm larger than the saline control.
- Positive open oral food challenge at baseline screening evaluation to the relevant food with dose-limiting symptoms at a single dose of ≤1000 mg (cumulative dose of ≤2043 mg) prior to starting omalizumab (using incremental doses of 3, 10, 30, 100, 300, 600, 1000 mg).
- Prior authorization from the patient's insurance provider for clinical use of omalizumab.
排除标准
- Clinically significant laboratory abnormalities in the past 6 months.
- Sensitivity or suspected/known allergy to any ingredients (including excipients) of omalizumab
- Poorly controlled or severe asthma/wheezing at screening
- History of severe anaphylaxis to the participant-specific food that will be used in this study, defined as neurological compromise or requiring intubation.
- Currently receiving oral, intramuscular (IM), or intravenous (IV) corticosteroids, tricyclic antidepressants, or β-blockers.
- Past or current history of cancer, or currently being investigated for possible cancer.
- Past or current history of any food immunotherapy, such as oral immunotherapy (OIT), sublingual immunotherapy (SLIT), epicutaneous immunotherapy (EPIT) within 6 months of screening.
- Treatment with monoclonal antibody therapy, such as omalizumab, dupilumab, benralizumab, mepolizumab, reslizumab, tezepelumab, or other immunomodulatory therapy within 6 months of screening.
- Inability to discontinue antihistamines for minimum wash-out periods required for skin-prick test or oral food challenge.
- Pregnant or breastfeeding, or intending to become pregnant during the study
- Evidence of clinically significant chronic disease.
研究组 & 干预措施
omalizumab
Omalizumab is approved by the FDA for the treatment of food allergy in patients aged 1 year and older. Omalizumab is administered as a subcutaneous injection at doses ranging from 75 mg to 600 mg every 2 or 4 weeks.
Omalizumab treatment is not provided as part of this study. Participants will receive omalizumab treatment as part of their routine care for food allergy as prescribed by their doctor in the clinical setting.
干预措施: Omalizumab (Drug)
结局指标
主要结局
Proportion of participants achieving pre-specified thresholds without dose-limiting symptoms during first post-treatment oral food challenge.
时间窗: Between ≥14 and ≤35 days after starting omalizumab
The pre-specified thresholds for response is defined as the ability to consume at least two more incremental doses of food protein during post-treatment oral food challenge (using incremental doses of 3, 10, 30, 100, 300, 600, 1000, 2000, 2000, and 2000 mg), than during the baseline oral food challenge. First post-treatment oral food challenge conducted between ≥14 and ≤35 days after starting omalizumab (after one or two doses of omalizumab depending on whether the participant is receiving omalizumab every 2 or 4 weeks).
次要结局
- The absolute change in oral food challenge threshold between baseline and the first post-treatment oral food challenge.(Baseline, between ≥14 and ≤35 days after starting omalizumab)
- The absolute change in oral food challenge threshold between the first and second post-treatment oral food challenges.(between ≥14 and ≤35 days after starting omalizumab, 4-6 months after starting omalizumab)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07845552
- 其他研究编号
- IRB00570914
日期
- 首次提交
- (8天前)
- 首次发布
- (昨天)
- 主要完成日期
- (2年后)
- 研究完成日期
- (2年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
There are no plans to share individual participant data.