EUCTR2015-004257-41-IT进行中（未招募）1 期
Peanut allergy oral immunoterapy study of AR101 for desensitization in children and adults (the palisade study) - PALISADE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
- 性别
- All
入选标准
- •-Age 4 through 55 years (inclusive)
- •-Clinical history of allergy to peanuts or peanut-containing foods
- •-Serum IgE to peanut of =0.35 kUA/L [determined by UniCAPTM within the past 12 months] and/or a SPT to peanut =3 mm compared to control
- •-Experience dose-limiting symptoms at or before the 100 mg challenge dose of peanut protein (measured as 200 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 adult subjects
- •-Written informed consent from parent/guardian for minor 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
- •-Not be residing at the same address as another subject in this or any peanut OIT study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •- History of 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, 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
- •- 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, see Appendix 2)
- •- 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, or ratio of FEV1 to forced vital capacity (FEV1/FVC) < 75% of predicted, with or without controller medications (only for age 6 or greater and able to do spirometry) or
- •- Inhaled corticosteroid (ICS) dosing of > 500 mcg daily fluticasone (or equivalent ICSs based on National Heart, Lung, and Blood Institute
- •[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
- •- History of steroid medication use (via intravenous [IV], intramuscular [IM] or oral administration) in any of the following manners:
- •- history of daily oral steroid dosing for >1 month during the past year or
- •- burst oral steroid course in the past 3 months prior to randomization or
- •- >2 burst oral steroid 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 DBPCFC
- •- Lack of an available palatable vehicle food to which the subject is not allergic
- •- Use of omalizumab within the past 6 months prior to screening, or current use of other investigational forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids)
- •- Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
- •- Pregnancy or lactation
- •- Having the same place of residence as another subject in the study
- •- Participation in another clinical trial within 30 days or 5 half-lives of the investigational product, whichever is longer, prior to randomization
- •- Developing dose limiting symptoms in reaction to the placebo part of the Screening DBPCFC
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