EUCTR2016-005004-26-FR进行中（未招募）1 期
AR101 TRIAL IN EUROPE MEASURING ORAL IMMUNOTHERAPY SUCCESS IN PEANUT ALLERGIC CHILDREN (ARTEMIS) - ARTEMIS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Age 4 through 17 years (inclusive)
- •Clinical history of allergy to peanuts or peanut-containing foods
- •Serum IgE to peanut = 0.35 kUA/L, inclusive (as determined by UniCAP™ within the past 12 months) and/or a peanut SPT wheal diameter = 3 mm compared to control
- •Experience dose-limiting symptoms at or before the 300 mg (444 mg cumulative) challenge dose of peanut protein (measured as 600 mg of peanut flour) on Screening DBPCFC conducted in accordance with PRACTALL (Practical Issues in Allergology, Joint United States/European Union Initiative) guidelines
- •Written informed consent from subject or parent/guardian for all subjects
- •Written assent from minor subjects as appropriate (e.g., above the age of 7 years or the applicable age per local regulatory requirements)
- •Use of effective birth control by female subjects of child-bearing potential
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 160
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •History of hemodynamically significant cardiovascular disease, including uncontrolled or inadequately controlled hypertension
- •History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of Screening DBPCFC
- •History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of, becoming unstable or requiring a change in chronic therapeutic regimen
- •History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia (e.g., difficulty swallowing, food getting stuck”), or recurrent gastrointestinal symptoms of undiagnosed etiology
- •Current participation in any other interventional study and/or participation in another interventional clinical study within 30 days or 5 half-lives of the investigational product, whichever is longer, prior to randomization
- •Participation in, and having received active treatment in, any previous clinical study of AR101 CODIT™
- •Participation in any peanut immunotherapy clinical study (including oral, sublingual, or epicutaneous) within 6 months prior to Screening
- •Subject is in build-up phase” of immunotherapy to another allergen (i.e., has not reached maintenance dosing)
- •Severe asthma (2007 NHLBI Criteria Steps 5 or 6)
- •Mild or moderate asthma (2007 NHLBI Criteria Steps 1-4), if uncontrolled or difficult to control as defined by any of the following:
- •- Forced expiratory volume in 1 second (FEV1) < 80% of predicted, with or without controller medications (only for age 6 years or greater and able to do spirometry); or
- •- Inhaled corticosteroid (ICS) dosing of > 500 mcg daily fluticasone (or equivalent ICS based on NHLBI dosing chart); or
- •- 1 hospitalization in the past year prior to Screening for asthma; or
- •- Emergency room (ER) visit for asthma within 6 months prior to Screening
- •History of high-dose corticosteroid use (e.g., 1 to 2 mg/kg of prednisone or the equivalent for > 3 days) by any route of administration in any of the following manners:
- •- history of daily corticosteroid dosing for > 1 month during the past year; or
- •- 1 corticosteroid course in the past 3 months; or
- •- > 2 corticosteroid courses in the past year = 1 week in duration
- •Inability to discontinue antihistamines 5 half-lives before the initial day of escalation, skin prick testing, or Screening DBPCFC
- •Lack of an available palatable vehicle food to which the subject is not allergic
- •Use of any therapeutic antibody (e.g., omalizumab, mepolizumab, reslizumab, etc.) or any other immunomodulatory therapy excluding aeroallergen, venom immunotherapy, or corticosteroids within the past 6 months
- •Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB), calcium channel blockers, or tricyclic antidepressants
- •Pregnancy or lactation
- •Residing at the same address as another subject in this or any peanut OIT study
- •Developing dose limiting symptoms in reaction to the placebo part of the Screenin
研究者
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