Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase 2 Study of AR201 Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy

Conditions
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Hen Egg Allergy

Intervention / Treatment
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* Biological: AR201 powder
* Biological: Placebo powder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2:1 randomization
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AR201 powder<br>Subjects were randomized to active arm of AIME01 and administered AR201 in escalating doses for approximately 6 months, followed by a maintenance dose for approximately 12 weeks | Biological: AR201 powder<br>* AR201 powder (Hen Egg allergen formulation) provided in capsules<br>|
| Placebo Comparator: Placebo powder<br>Subjects were randomized to placebo arm of AIME01 and administered placebo for approximately 6 months, followed by maintenance placebo for approximately 12 weeks. | Biological: Placebo powder<br>* Placebo powder provided in capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Tolerating a Single Highest Dose of at Least 1000 mg Dried Egg White Protein With no More Than Mild Symptoms at the Exit Double-blind Placebo Controlled Food Challenge (DBPCFC) |  | 9-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC |  | 9-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AR201, CODIT™ (characterized oral desensitization immunotherapy™), Hen Egg Allergic Children, Desensitization, Allergy, Hen Egg Allergy, Characterized Hen Egg Allergen, Oral Immunotherapy, CHEA (Characterized Hen Egg Allergen), Food Allergy