EUCTR2018-001749-15-FR进行中（未招募）1 期
Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON) - POSEIDO
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
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
- •Each subject eligible to participate in this study must meet all the following criteria:
- •1. Aged 1 to < 4 years at randomization.
- •2. Written informed consent from the legal guardian/parent (or both parents where required by local authorities). Provide assent where required and as appropriate per local requirements.
- •3. Documented history of physician-diagnosed IgE-mediated peanut allergy that includes the onset of characteristic signs and symptoms of allergy within 2 hours of known oral exposure to peanut or peanut-containing food. In general, characteristic signs and symptoms of IgE-mediated allergic reactions are objective and affect the target organs of skin, GI tract, upper/lower respiratory tract, cardiovascular system, or a combination of target organs as follows:
- •System: Examples of Symptoms (Sampson, 2014)
- •Cutaneous: Pruritus, erythema/flushing, urticaria, angioedema, contact urticaria
- •Ocular: Pruritus, tearing, conjunctival injection, periorbital edema
- •Upper respiratory tract: Pruritus, nasal congestion, rhinorrhea, sneezing, hoarseness, laryngeal edema
- •Lower respiratory tract: Cough, wheezing, dyspnea, chest tightness/pain
- •Gastrointestinal: Oral pruritus, oral angioedema (lips, tongue, or palate), colicky abdominal pain, nausea, emesis, diarrhea
- •Cardiovascular: Tachycardia, dizziness, hypotension, loss of consciousness/ fainting
- •4. Mean wheal diameter on skin prick test (SPT) to peanut of at least 3 mm greater than the negative control (diluent) or serum IgE to peanut = 0.35 kUA/L, obtained within 12 months before randomization.
- •5. Development of age-appropriate dose-limiting allergy symptoms after consuming single doses of peanut protein > 3 mg to = 100 mg in a screening DBPCFC.
- •6. A palatable vehicle food to which the subject is not allergic must be available for administering study product.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 105
- •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
- •Each subject eligible to participate in this study must NOT meet any of the following exclusion criteria:
- •1. History of severe or life-threatening anaphylaxis.
- •2. History of hemodynamically significant cardiovascular or renovascular disease, including uncontrolled or inadequately controlled hypertension.
- •3. History of EoE; other eosinophilic GI disease; chronic, recurrent, or severe gastroesophageal reflux disease (GERD); or symptoms of dysphagia (eg, difficulty swallowing, food getting stuck”).
- •4. Recurrent GI symptoms considered clinically significant in the opinion of the investigator.
- •5. History of a mast cell disorder including mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (eg, cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema.
- •6. Moderate or severe persistent asthma (criteria steps 3-6; National Heart, Lung, and Blood Institute [NHLBI], 2007).
- •7. Mild asthma (criteria steps 1-2; NHLBI, 2007) that is uncontrolled or difficult to control based on NHLBI 2007 criteria.
- •8. History of high-dose corticosteroid use (eg, 1-2 mg/kg prednisone or equivalent for > 3 days) by any route of administration as defined by any of the following:
- •Steroid administered daily for > 1 month within 1 year before screening
- •One steroid course within 6 months before screening
- •More than 2 steroid courses = 1 week in duration within 1 year before screening
- •9. History of food protein-induced enterocolitis syndrome (FPIES).
- •10. Recurrent urticaria.
- •11. History of developmental delay or speech delay that precludes age-appropriate communication, in the opinion of the investigator.
- •12. History of chronic disease (except mild intermittent asthma, mild persistent asthma that is controlled, atopic dermatitis, or allergic rhinitis) that is or is at significant risk of becoming unstable or requiring a change in a chronic therapeutic regimen.
- •13. Unable to discontinue antihistamines and other medications that could interfere with the assessment of an allergic reaction for 5 half-lives of the medication before the screening SPT, first day of dose escalation, and DBPCFCs.
- •14. Use or anticipated use of a prohibited medication (eg, beta blockers [oral], angiotensin converting enzyme inhibitors, angiotensin receptor blockers, calcium channel blockers, or tricyclic antidepressants), monoclonal antibody, or any other immunomodulatory therapy (including immunosuppressive medications).
- •15. Treatment with any form of immunotherapy for any food allergy within 6 months before screening.
- •16. Participation in another clinical trial within 30 days or 5 half-lives of the investigational product, whichever is longer, before screening.
- •17. Allergy to oat.
- •18. Hypersensitivity to epinephrine or any of the excipients in the epinephrine autoinjector.
- •19. Any other condition (concurrent disease, infection, comorbidity, or psychiatric or psychological disorders) or reason that may interfere with the ability to participate in the study, cause undue risk, or complicate the interpretation of data, in the opinion of the investigator or medical monitor.
- •20. Resides at the same place as another subject in any AR101 interventional trial.
- •21. Lives in the same household or is a dependent of a sponsor employee or site staff involved in conducting this study.
研究者
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