Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents
Peanut Allergy
About this trial
This is an interventional treatment trial for Peanut Allergy focused on measuring 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)
Eligibility Criteria
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
Sites / Locations
- Hospital Universitario Germans Trias i Pujol
- Corporacio Sanitaria Parc Tauli
- Hospital Universitario Severo Ochoa
- Hospital Universitario Vall d'Hebron - PPDS
- Hospital Infantil Universitario Niño Jesus
- Hospital Universitario Infanta Leonor
- Hospital Clinico San Carlos
- Complejo Hospitalario de Navarra
- Hospital Universitario de Canarias
- Hospital Universitario Virgen Macarena
- Hospital Universitari i Politecnic La Fe de Valencia
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
Group 1 (AR101 Treatment + standard of care)
Group 2 (Standard of Care Treatment)
Subjects receiving AR101 treatment will have 3 consecutive AR101 dosing periods before exiting (completing) the study: initial dose escalation, up dosing, and maintenance.
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.