Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children
Status: | Completed |
---|---|
Conditions: | Allergy, Allergy |
Therapuetic Areas: | Otolaryngology |
Healthy: | No |
Age Range: | 4 - 17 |
Updated: | 10/26/2018 |
Start Date: | May 8, 2017 |
End Date: | September 23, 2018 |
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children Ages 4 to 17 Years
This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101
using the characterized oral desensitization immunotherapy (CODIT ™) regimen in
peanut-allergic children.
using the characterized oral desensitization immunotherapy (CODIT ™) regimen in
peanut-allergic children.
The primary objective is to assess the safety and tolerability of AR101 when used in a CODIT™
regimen for approximately 6 months in peanut-allergic children.
regimen for approximately 6 months in peanut-allergic children.
Key Inclusion Criteria:
- Age 4 to 17 years, inclusive
- History of physician-diagnosed peanut allergy
- Positive SPT for peanut and elevated psIgE
- Written informed consent from the subject's parent/guardian
- Written assent from the subject as appropriate (per local regulatory requirements)
- Use of effective birth control by sexually active female subjects of childbearing
potential
Key Exclusion Criteria:
- Subjects in whom the clinical diagnosis of peanut allergy is uncertain
- History of cardiovascular disease, including uncontrolled or inadequately controlled
hypertension
- History of severe or life-threatening episode of anaphylaxis or anaphylactic shock
within 60 days of screening
- 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 undiagnosed etiology
- History of a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic
idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold
urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema
- Any other condition that, in the opinion of the Investigator, precludes participation
for reasons of safety
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