A 15 Months, Double-Blind, Randomized Controlled Trial Comparing 20 Weeks of Two Dosages of Omalizumab to Placebo to Accelerate a Symptom-driven Oral Immunotherapy Schedule in Subjects Aged 6 to 25 Years With Multiple Food Allergies
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- To determine the efficacy of omalizumab at decreasing time-to-maintenance during a symptom-driven multi-food OIT protocol.
研究概览
简要总结
This study will determine the dose-related efficacy of a 20-week treatment of omalizumab started 8 weeks before the onset of a symptom-driven multi-food oral immunotherapy (OIT) protocol at decreasing time to OIT maintenance dose. Two dosages of omalizumab will be compared to placebo during an oral immunotherapy protocol for three simultaneous food allergens.
详细描述
This is a phase 2b, multi-center randomized controlled trial comparing 2 doses of omalizumab to placebo in subjects 6 to 25 years old with multiple food allergies undergoing a symptom-driven multi-food OIT protocol.
Subjects will undergo a screening period involving a DBPCFC to a mix of three allergens which will determine their eligibility and eliciting dose.
Eligible subjects will be randomized to one of 2 omalizumab dosages or placebo at a ratio of 2:2:1 for a total period of 20 weeks.
They will undergo initial food escalation (IFE) to determine their starting food treatment mix dose for three simultaneous food allergens after a pre-treatment period of 8 weeks with the study drug.
Subjects will undergo up-dosing OIT visits at the clinic every two weeks, until a maintenance dose of 1500mg of protein (500mg per food) is reached (primary endpoint).
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
- 6 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Omalizumab 16 mg/kg
Participants will receive omalizumab 16 mg/kg monthly doses for 12 weeks, followed by omalizumab 8 mg/kg monthly for 4 weeks and then omalizumab 4 mg/kg monthly for 4 weeks.
Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.
干预措施: Omalizumab 16mg/kg (Biological)
Omalizumab 16 mg/kg
Participants will receive omalizumab 16 mg/kg monthly doses for 12 weeks, followed by omalizumab 8 mg/kg monthly for 4 weeks and then omalizumab 4 mg/kg monthly for 4 weeks.
Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.
干预措施: Multi-food oral immunotherapy (OIT) (Other)
Omalizumab 8 mg/kg
Participants will receive omalizumab 8 mg/kg monthly doses for 12 weeks, followed by omalizumab 4 mg/kg monthly for 4 weeks and then omalizumab 2 mg/kg monthly for 4 weeks.
Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.
干预措施: Omalizumab 8mg/kg (Biological)
Omalizumab 8 mg/kg
Participants will receive omalizumab 8 mg/kg monthly doses for 12 weeks, followed by omalizumab 4 mg/kg monthly for 4 weeks and then omalizumab 2 mg/kg monthly for 4 weeks.
Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.
干预措施: Multi-food oral immunotherapy (OIT) (Other)
Placebo
Participants will receive placebo doses for 20 weeks. The doses will be injected every 2 or 4 weeks depending on the weight of the participant.
Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.
干预措施: Placebo (Biological)
Placebo
Participants will receive placebo doses for 20 weeks. The doses will be injected every 2 or 4 weeks depending on the weight of the participant.
Multi-food oral immunotherapy following a symptom-driven schedule will begin 8 weeks after starting study drug.
干预措施: Multi-food oral immunotherapy (OIT) (Other)
结局指标
主要结局
To determine the efficacy of omalizumab at decreasing time-to-maintenance during a symptom-driven multi-food OIT protocol.
时间窗: Assessed up to 52 weeks after IFE
Time from IFE to target multi-food protein maintenance dose of 1500 mg of total food protein
次要结局
- Average up-dosing speed while on study drug.(From week 0 to week 12 post IFE)
- Change in reactivity threshold to food treatment mix after pre-treatment with study drug.(Measured 8 weeks after starting investigational product)
- Mean cumulative function of allergic adverse events attributable to food dosing throughout the trial.(For one year following IFE)
- Rate of treatment failure(At any time during the 12-month OIT phase)
研究者
Philippe Bégin
Principal Investigator
St. Justine's Hospital