Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
Condition: Hen Egg Allergy
MeSH terms: Hypersensitivity; Egg Hypersensitivity
Intervention: AR201 powder; Placebo powder
Intervention description: AR201 powder (Hen Egg allergen formulation) provided in capsules; Placebo powder provided in capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2:1 randomization
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double-Blinded
Enrollment: 15.0
Sex: All
Minimum age: 4 Years
Maximum age: 26 Years
Healthy volunteers: No
Keywords: CODIT™ (characterized oral desensitization immunotherapy™); Hen Egg Allergic Children; Desensitization; AR201; Allergy; Hen Egg Allergy; Characterized Hen Egg Allergen; Oral Immunotherapy; CHEA (Characterized Hen Egg Allergen); Food Allergy

Summary:

      To determine the efficacy and safety of AR201 in a characterized oral desensitization
      immunotherapy (CODIT™) regimen in hen egg-allergic subjects aged 4 to 26 years, inclusive.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  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

        Key Exclusion Criteria:

          -  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