EUCTR2015-004257-41-IE进行中（未招募）1 期
PEANUT ALLERGY ORAL IMMUNOTHERAPY 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
- •1. Age 4 through 55 years (inclusive)
- •2. Clinical history of allergy to peanuts or peanut-containing foods
- •3. 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
- •4. 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
- •5. Written informed consent from adult subjects
- •6. Written informed consent from parent/guardian for minor subjects
- •7. Written assent from minor subjects as appropriate (eg, above the age of 7 years or the applicable age per local regulatory requirements)
- •8. Use of effective birth control by female subjects of child-bearing potential
- •9. 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: 400
- •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) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension (see also Section 5.10 Prohibited Medications)
- •2. History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of Screening DBPCFC
- •3. 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
- •4. History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia (eg, difficulty swallowing, food getting stuck”), or recurrent gastrointestinal symptoms of undiagnosed etiology
- •5. Current participation in any other interventional study
- •6. Subject is in build-up phase” of immunotherapy to another allergen (ie, has not reached maintenance dosing)
- •7. Severe asthma (2007 NHLBI Criteria Steps 5 or 6, see Appendix 2)
- •8. Mild or moderate asthma (2007 NHLBI Criteria Steps 1-4), if uncontrolled or difficult to control as defined by any of the following:
- •1. 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
- •2.Inhaled corticosteroid (ICS) dosing of > 500 mcg daily fluticasone (or equivalent ICSs based on National Heart, Lung, and Blood Institute [NHLBI] dosing chart) or
- •3. One hospitalization in the past year prior to screening for asthma or
- •4. Emergency room (ER) visit for asthma within 6 months prior to screening
- •9. History of steroid medication use (via intravenous [IV], intramuscular [IM] or oral administration) in any of the following manners:
- •10. History of daily oral steroid dosing for > 1 month during the past year or
- •11. Burst oral (IM or IV) steroid course in the past 3 months prior to randomization or
- •12. > 2 burst oral (IM or IV) steroid courses in the past year =1 week in duration
- •13. Inability to discontinue antihistamines 5 half-lives before the initial day of escalation, skin prick testing, or DBPCFC
- •14. Lack of an available palatable vehicle food to which the subject is not allergic
- •15. Use of any therapeutic antibody (eg omalizumab, mepolizumab, reslizumab, etc.), any investigational peanut immunotherapy (eg oral, sublingual, epicutaneous), or any other immunomodulatory therapy excluding corticosteroids within the past 6 months (see also Section 5.10 Prohibited Medications)
- •16. Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers (see also Section 5.10 Prohibited Medications)
- •17. Pregnancy or lactation
- •18. Having the same place of residence as another subject in the study
- •19. Participation in another clinical trial within 30 days or 5 half-lives of the investigational product, whichever is longer, prior to randomization
- •20. Developing dose limiting symptoms in reaction to the placebo part of the Screening DBPCFC
- •21. History of a mast cell disorder, including mastocytosis, urticaria pigmentosa, and hereditary or idiopathic angioedema
- •22. Allergy to oat
- •23. Hypersensitivity to epinephrine and any of the excipients in the product
研究者
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