A Double-blind Randomized Controlled Trial of 6-month of Abatacept vs Placebo as Adjuvant to Peanut Oral Immunotherapy to Induce Immunologic Changes in Patients With Severe Persistent Peanut Allergy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Peanut specific/total IgE at week 24
研究概览
简要总结
This is a phase 2a, multi-center, randomized and double-blind placebo-controlled trial comparing 24 weeks of abatacept versus placebo used as adjuvant to oral immunotherapy to induce remission in adolescents and adults with persistent severe peanut allergy.
This is a proof-of-concept trial in which the primary outcome will be the suppression of the initial peanut specific IgE surge during OIT, which is used as a proxy outcome of peanut allergy remission.
Adolescents and adults with persistent severe peanut allergy (n=14) will be randomized to either abatacept or placebo at a ratio 1:1 for a total period of 24 weeks. Peanut oral immunotherapy will be initiated the day following the first administration of the investigational product. Sustained tolerance to peanut will be assessed at 36 weeks.
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
- 14 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 14 to 50 years old at screening visit
- •History of IgE mediated allergy to peanut protein
- •ImmunoCAP IgE level > 50 kU/L for peanut;
- •Total IgE level < 5000 kU/L
- •Willing to comply to all study requirements during participation in the study;
排除标准
- •Previous adverse reactions to abatacept;
- •Known hypersensitivity to abatacept or any of its components;
- •Patients at risk of sepsis, such as immunocompromised or HIV positive;
- •Patient undergoing a treatment with any other biologic agent;
- •Uncontrolled asthma;
- •Unstable angina, significant arrhythmia, uncontrolled hypertension, chronic sinusitis, or other chronic or immunological diseases that, in the judgment of the investigator, might interfere with the evaluation, administration of the test drug or pose additional risk to the subject (e.g., gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease);
- •Current users of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants or beta-blocker
- •Concurrent/prior use of immunomodulatory therapy (within 6 months);
- •A diagnosis of eosinophilic esophagitis, eosinophilic colitis, or eosinophilic gastritis;
- •Pregnant or breastfeeding women;
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Abatacept
干预措施: Abatacept (Drug)
Abatacept
干预措施: Peanut oral immunotherapy (Other)
Placebo
干预措施: Peanut oral immunotherapy (Other)
结局指标
主要结局
Peanut specific/total IgE at week 24
时间窗: 24 weeks
Relative change in peanut specific/total IgE from baseline to week 24
次要结局
- Desensitization(36 weeks)
- Peanut-specific IgG4/IgE ratio at week 24(24 weeks)
- Peanut-specific IgG4 at week 24(24 weeks)
- Sustained tolerance(Assessed between week 36 and week 48)
- Food dosing reactions(48 weeks)
- Desensitization speed(36 weeks)
- Adverse events(48 weeks)
研究者
Philippe Bégin
Associate professor
St. Justine's Hospital