Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adolescents: Real-World, Open-Label, Quality of Life Study - Quality of Life study of AR101 CODIT

Aimmune Therapeutics, Inc.0 sites200 target enrollmentStarted: July 20, 2018Last updated: January 7, 2019

Overview

No summary available.

•1\. Aged 4 to 17 years, inclusive, at screening
•2\. Written informed consent from subjects, as appropriate per local requirements, and legal
•guardian/parent (or both parents where required by local authorities) of subjects who are
•3\. Written assent from subjects who are minors, as appropriate per local requirements
•4\. Written informed consent from the parent/caregiver who will complete relevant questionnaires during the study
•5\. History of physician\-diagnosed immunoglobulin (Ig) E\-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, gastrointestinal (GI) tract, upper/lower respiratory tract, cardiovascular system, or a combination of target organs
•6\. Mean wheal diameter on SPT to peanut \= 8 mm greater than the negative saline control at screening
•7\. Serum IgE to peanut of \= 14 kUA/L at screening
•8\. For sexually active females of childbearing potential, use of a highly effective method of birth control, defined as one that results in a low failure rate (ie, \< 1% per year) when used consistently and correctly
•Are the trial subjects under 18? yes

•1\. Uncertain clinical diagnosis of peanut allergy
•2\. History of severe or life\-threatening anaphylaxis or anaphylactic shock within 60 days before screening
•3\. History of eosinophilic esophagitis (EoE); other eosinophilic GI disease; chronic, recurrent, or severe gastroesophageal reflux disease (GERD); symptoms of dysphagia (eg, difficulty swallowing, food getting stuck”); or recurrent GI symptoms of any etiology
•4\. History of a mast cell disorder including systemic mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (eg, cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema
•5\. Severe persistent asthma
•6\. Mild or moderate asthma (criteria steps 1\-4; NHLBI, 2007\) that is uncontrolled or difficult to control
•7\. History of high\-dose corticosteroid medication use (eg, \> 3 days at 1\-2 mg/kg of prednisone or equivalent)
•8\. History of chronic disease (except asthma, atopic dermatitis, or allergic rhinitis) that is or is at significant risk of becoming unstable or requiring a change in a chronic therapeutic regimen, including malignancies within 5 years before screening and autoimmune diseases
•9\. History of cardiovascular disease including uncontrolled or inadequately controlled hypertension
•10\. Use of beta\-blockers (oral), angiotensin\-converting enzyme inhibitors, angiotensin receptor blockers, calcium channel blockers, or tricyclic antidepressants

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