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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Peanut Allergy

Intervention / Treatment
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* Biological: AR101


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 (AR101 Treatment + standard of care)<br>Subjects receiving AR101 treatment will have 3 consecutive AR101 dosing periods before exiting (completing) the study: initial dose escalation, up dosing, and maintenance. | Biological: AR101<br>* AR101 powder<br>|
| No Intervention: Group 2 (Standard of Care Treatment)<br>Subjects receiving standard of care alone will have approximately 18 months of observation before study exit, with an OLFC (open label food challenge) approximately 12 months after randomization. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of Life | The primary analyses will use scores from a family of proxy- and self-reported disease-specific HRQOL measures to assess the HRQOL of peanut-allergic subjects treated with AR101 or standard of care alone during the study. The relevant disease-specific HRQOL questionnaires include the FAQLQ-PF (parent form), FAQLQ-PFT (parent form teenager), FAQLQ-CF (child form), FAQLQ-TF (teenager form), FAIM-PF (parent form), FAIM-PFT (parent form teenager), FAIM-CF (child form), and FAIM-TF (teenager form). | 18 months per subject, approximately 30 months for the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AR101, Characterized Peanut Allergen (CPNA), (Characterized Peanut Allergen) OIT, Peanut Allergy, Allergy, Peanut-Allergic Children, Peanut-Allergic Adolescents, Desensitization, Quality of Life, OIT (oral immunotherapy), CODIT (TM) Characterized Oral Desensitization Immunotherapy (TM)