Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Aimmune Therapeutics, Inc.
This is a phase 2, randomized, double-blind, placebo-controlled study of the efficacy and safety of AR201 in a CODIT regimen in hen egg-allergic subjects aged 4 to 26 years, inclusive. The study was conducted at 8 sites in the United States.
Age
4–26
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 4 to 26 years, inclusive
Written informed consent from subjects, as appropriate per local requirements, and parent/guardian
Written assent from subjects who are minors, as appropriate per local requirements
History of physician-diagnosed hen egg allergy
Elevated egg specific IgE and/or mean wheal diameter on SPT to egg
Experience dose-limiting symptoms at or before the 300 mg challenge dose of dried egg white protein on Screening DBPCFC
Use of effective birth control by sexually active female subjects of childbearing potential
You may not be if
History of severe or life-threatening anaphylaxis within 60 days before screening
History of non-IgE mediated hen egg allergy such as food protein-induced enterocolitis syndrome (FPIES)
History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia or recurrent gastrointestinal symptoms of unknown etiology
History of a mast cell disorder including systemic mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema
History of chronic disease (except asthma, atopic dermatitis, or allergic rhinitis) which may require a change in immunosuppressive medication regimen or chronic corticosteroid use
History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
Developing dose-limiting symptoms to placebo challenge during the Screening DBPCFC
Having the same place of residence as another subject in the study
Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
Clareo Health | Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
