NCT05069831已完成1 期
JAK Inhibition in Food Allergy
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- change in skin prick test
研究概览
简要总结
This study will assess the role for an oral targeted medication, abrocitinib, as a new treatment option for food allergy patients that would avoid injections. Abrocitinib, which has successfully completed phase three trials for atopic dermatitis, could serve as a single therapy for two conditions in many patients with multiple atopic conditions.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 50 years old
- •Participant must be able to understand and perform informed consent.
- •IgE-mediated food allergy to at least one of the following foods as defined by (regarding at least one of the foods):
- •° Foods: peanut, cashew, walnut, hazelnut, sesame, cod, and/or shrimp, history of an acute allergic reaction (urticaria, angioedema, cough, wheeze, and/or repetitive vomiting within an hour of ingestion, and history of positive skin or serum IgE test, and current strict avoidance of the food, and current possession of physician-prescribed self-injectable epinephrine, and skin test wheal 5 mm or greater average diameter
- •Current or past eczema.
- •If female of childbearing potential, must have a negative pregnancy test (serum or urine) and agree to abstinence or acceptable contraception.
- •Plan to remain in the Tri-State area during the trial for visits.
- •Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sunlamps, or other ultraviolet (UV) light sources during the study.
- •If receiving concomitant medications for any reason other than AD, must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1 and through the duration of the study.
排除标准
- •Unwilling or unable to give written informed consent or comply with protocol.
- •Unable to swallow pill.
- •Use of dupilumab within 6 weeks of enrollment.
- •Prior use or allergy to drugs related to abrocitinib (ruxolitinib, upadacitinib, etc).
- •Use of any other biologic (monoclonal antibody) medication within 12 weeks or 5 half-lives of drug, if known.
- •Allergy to any excipients within abrocitinib.
- •Use of build-up environmental immunotherapy; any food oral immunotherapy;or systemic oral, IV or IM steroids including but not limited to- prednisone, methylprednisolone, prednisolone, solumedrol, solucortef, dexamethasone in the past 4 weeks or 5 half-lives of drug, if known.
- •Use of CYP2C9 and CYP2C19 inducers (such as carbamazepine, norfluoxetine, etc.) within 5 half-lives of the inducer plus 14 days prior to the first dose of study intervention.
- •Use of CYP2C9 and CYP2C19 inhibitors within 1 week of first dose of study intervention or within 5 half-lives (if known) of the inhibitor, whichever is longer.
- •Unable to stop long-acting antihistamines within minimum wash out period required for SPTs at screening and site visits
- •History of or significant risk factor(s) for cardiovascular disease
研究组 & 干预措施
Abrocitinib 200mg
Active Comparator
This arm will receive 200mg of the study drug
干预措施: Abrocitinib (Drug)
Abrocitinib 100mg
Active Comparator
This arm will receive 100mg of the study drug
干预措施: Abrocitinib (Drug)
结局指标
主要结局
change in skin prick test
时间窗: baseline and after 4 months of treatment
change in skin prick test size after four months of therapy.
change in basophil activation
时间窗: baseline and after 4 months of treatment
change in basophil activation as measured by %CD63 AUC
次要结局
- change in specific immunoglobulin E (sIgE)(baseline and after 4 months of treatment)
- change in antigen-specific T-cell(baseline and after 4 months of treatment)
- change in FENO(baseline and after 4 months of treatment)
研究者
Scott Sicherer
Professor, Pediatrics
Icahn School of Medicine at Mount Sinai
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Microbiota as Potential Target for Food AllergyCow Milk AllergyNCT02087930Federico II University600
已完成
不适用
Microbiota and AllergyAllergyNCT04750980Federico II University120
已完成
2 期
Oral Immunotherapy (OIT) for Peanut AllergyPeanut HypersensitivityNCT00815035University of North Carolina, Chapel Hill16
Unknown
不适用
Oral Immunotherapy in Food Allergy in FinlandFood HypersensitivityImmune System DiseasesAnaphylaxisNCT02640014Helsinki University Central Hospital250
已完成
2 期
Peanut Allergy Oral Immunotherapy DesensitizationPeanut AllergyNCT01601522Hamilton Health Sciences Corporation43