Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents

Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adolescents: Real World, Open Label, Quality of Life Study

To compare the HRQOL of AR101 characterized oral desensitization immunotherapy (CODIT™) in combination with standard of care (peanut avoidance, education) versus standard of care alone in peanut-allergic subjects aged 4 to 17 years.

This is a phase 3b, randomized, open label, European study of the HRQOL of AR101 in combination with standard of care compared with standard of care alone in approximately 200 peanut-allergic subjects aged 4 to 17 years, inclusive.

Key Inclusion Criteria:

• Age 4 through 17 years
• History of physician diagnosed IgE mediated peanut allergy with characteristic signs and symptoms
• Positive SPT for peanut
• Positive serum IgE to peanut
• Written informed consent from the subject's parent/guardian
• Written assent from the subject as appropriate
• Use of effective birth control by sexually active female subjects of childbearing potential

Key Exclusion Criteria:

• Uncertain clinical diagnosis of peanut allergy
• History of severe or life threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
• Severe persistent asthma or uncontrolled mild or moderate asthma
• History of eosinophilic esophagitis, other eosinophilic gastrointestinal disease, severe gastroesophageal reflux disease, symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology
• History of a mast cell disorder, including mastocytosis, urticarial pigmentosa, and hereditary or idiopathic angioedema
• History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
• History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of becoming, unstable or requiring a change in chronic therapeutic regimen