Peanut Oral Immunotherapy Study of Early Intervention for Desensitization

To determine the efficacy and safety of AR101 in a characterized oral desensitization
immunotherapy (CODIT™) regimen compared with placebo in peanut‑allergic children aged 1 to <
4 years.

Inclusion Criteria:

- Aged 1 to < 4 years at randomization.

- Written informed consent from the legal guardian/parent (or both parents where
required by local authorities). Provide assent where required and as appropriate per
local requirements.

- Documented history of physician‑diagnosed IgE‑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, GI tract, upper/lower respiratory tract, cardiovascular system, or a
combination of target organs.

- Mean wheal diameter on skin prick test (SPT) to peanut of at least 3 mm greater than
the negative control (diluent) or serum IgE to peanut ≥ 0.35 kUA/L, obtained within 12
months before randomization.

Exclusion Criteria:

- History of severe or life‑threatening anaphylaxis.

- History of hemodynamically significant cardiovascular or renovascular disease,
including uncontrolled or inadequately controlled hypertension.

- History of EoE; other eosinophilic GI disease; chronic, recurrent, or severe
gastroesophageal reflux disease (GERD); or symptoms of dysphagia (eg, difficulty
swallowing, food "getting stuck").

- History of a mast cell disorder including mastocytosis, urticaria pigmentosa, chronic
idiopathic or chronic physical urticaria beyond simple dermatographism.

- Mild asthma that is uncontrolled or difficult to control.

- Moderate or severe persistent asthma.

- History of food protein‑induced enterocolitis syndrome .

- History of chronic disease that is or is at significant risk of becoming unstable or
requiring a change in a chronic therapeutic regimen.

- Recurrent GI symptoms considered clinically significant.

- History of high‑dose corticosteroid use.