Preventing Life-Threatening Allergic Reactions With Acalabrutinib, an FDA-Approved Bruton's Tyrosine Kinase Inhibitor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Highest Dose of Peanut That is Tolerated During Oral Food Challenge
研究概览
简要总结
Food allergy is a potentially life-threatening condition, and its prevalence continues to increase despite public health efforts. There are currently no known therapies that can reliably prevent food-induced anaphylaxis. This is an open-label study designed to determine the ability acalabrutinib to prevent signs and symptoms of anaphylaxis during an oral food challenge in food-allergic adults.
详细描述
Approximately 15 million people (including 8% of children) in the US have a food allergy and are at risk for life-threatening systemic reactions to foods. There is an unmet need for treatments capable of preventing such reactions. This is a phase II, single-center, open label trial involving the use of acalabrutinib (brand name Calquence®) to prevent food-induced anaphylaxis in adults with food allergy. Acalabrutinib is FDA-approved to treat certain medical conditions, but it is not approved to treat allergies.
Adult participants with a physician-diagnosed food allergy to peanut and/or tree nuts will be enrolled. These participants will undergo an oral food challenge to peanut or a tree nut under close physician supervision to determine participants' baseline reactivity. After a rest period, the participants will take 4 oral doses of acalabrutinib 100 mg, and then repeat the oral food challenge to see if acalabrutinib will reduce participants' reactivity to peanut or tree nuts.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of immunoglobulin E (IgE)-mediated food allergy to peanut or tree nut
- •Positive skin prick test to the trigger food (either peanut or tree nut)
- •Objective clinical reaction to the food allergen during baseline oral food challenge
- •Women of child bearing potential must agree to two forms of highly effective contraception (hormonal, device, or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 days following completion of acalabrutinib therapy.
- •Ability to understand and the willingness to sign a written informed consent
- •Ability to clearly understand and speak English at an 8th grade reading level
排除标准
- •Participants who have been on immunomodulatory therapies or oral corticosteroids within 1 month prior to enrollment
- •Participants with symptoms consistent with food reactions other than type 1 hypersensitivity
- •History of allergic reaction to acalabrutinib
- •History of idiopathic urticaria, dermatographism, idiopathic or unexplained anaphylaxis, or anaphylaxis (to foods or otherwise) resulting in intubation, prolonged hypotension, or neurological sequelae- History of cardiovascular disease
- •History of a bleeding disorder, or those currently taking blood thinners
- •History of stroke
- •History of gastrointestinal ulcer
- •History of cancer (other than skin cancer)
- •Positive HIV status or history of other immunodeficiency
- •Active or latent Hepatitis B or C infection based on laboratory testing
- •Currently pregnant or nursing
- •Current use of proton pump inhibitors (Note: participants currently receiving proton pump inhibitors who switch to H2-receptor antagonists or other antacids are eligible for enrollment to this study).
- •Active significant infection
- •Major surgical procedure within 28 days of enrollment
- •Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura
- •Difficulty swallowing oral medication, or significant gastrointestinal disease that would limit absorption of oral medication
- •Concurrent participation in another therapeutic clinical trial
研究组 & 干预措施
Acalabrutinib
Participants will be given acalabrutinib (four doses of 100 mg of acalabrutinib to be taken orally twice daily).
干预措施: Acalabrutinib (Drug)
结局指标
主要结局
Highest Dose of Peanut That is Tolerated During Oral Food Challenge
时间窗: Baseline and Day 2 of treatment
The highest dose of peanut protein (in mg) tolerated during oral food challenge before and after acalabrutinib treatment was determined by assessing clinical symptoms and physcial exam findings in each organ system during the challenge. Symptoms were given a numeric score based on the American Academy of Allergy, Asthma, and Immunology/European Academy of Allergy and Clinical Immunology PRACTALL consensus system to grade symptom severity and the likelihood of their representing a true objective clinical reaction to peanut.
次要结局
- Area Under the Curve Severity of Clinical Reaction to Peanut(Baseline and Day 2 of treatment)
- Skin Prick Test Size to Peanut(Baseline and Day 2 of treatment)
- Basophil Activation Testing(Baseline and Day 2 of treatment)