Clinical Trial Finder

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 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

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 will be conducted at approximately 30 sites in the United States.

Arms

Active Comparator: AR201 powder (Hen Egg Allergen formulation)

Subjects will be randomized to active arm of AIME01 and will be administered IP (AR201) in escalating doses for approximately 6 months, followed by a maintenance dose for approximately 12 weeks

Placebo Comparator: Placebo powder

Subjects will be randomized to placebo arm of AIME01 and will be administered escalating doses of IP (placebo) for approximately 6 months, followed by a maintenance dose for approximately 12 weeks

Interventions

Biological: - AR201 Powder

AR201 powder provided in capsules (Hen Egg allergen formulation)

Biological: - Placebo powder

Placebo powder provided in capsules