Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON) - POSEIDO

Aimmune Therapeutics , Inc.0 个研究点目标入组 132 人开始时间: 2019年2月25日最近更新: 2020年11月23日

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•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\. Sensitivity to peanut, defined as one of the following:
•a. No known history of peanut ingestion and has serum IgE to peanut \= 5 kUA/L within 12 months before randomization.
•b. 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, and has a 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.
•\*Characteristic signs and symptoms of IgE\-mediated allergic reactions are generally 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

•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 anytime before the screening DBPCFC.
•2\. History of hemodynamically significant cardiovascular or renovascular disease, including uncontrolled or inadequately controlled hypertension.
•3\. History of biopsy\-confirmed diagnosis 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

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