Peanut Allergy Clinical Trial
Official title:
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adolescents: Real World, Open Label, Quality of Life Study
Verified date | June 2021 |
Source | Aimmune Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare the HRQOL of AR101 characterized oral desensitization immunotherapy (CODITâ„¢) in combination with standard of care (peanut avoidance, education) versus standard of care alone in peanut-allergic subjects aged 4 to 17 years.
Status | Terminated |
Enrollment | 1 |
Est. completion date | November 23, 2018 |
Est. primary completion date | November 23, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Germans Trias i Pujol | Badalona | Barcelona |
Spain | Hospital Universitario Vall d'Hebron - PPDS | Barcelona | |
Spain | Hospital Universitario Severo Ochoa | Leganes | Madrid |
Spain | Hospital Clinico San Carlos | Madrid | |
Spain | Hospital Infantil Universitario Niño Jesus | Madrid | |
Spain | Hospital Universitario Infanta Leonor | Madrid | |
Spain | Complejo Hospitalario de Navarra | Pamplona | |
Spain | Corporacio Sanitaria Parc Tauli | Sabadell | Barcelona |
Spain | Hospital Universitario de Canarias | Santa Cruz de Tenerife | |
Spain | Hospital Universitario Virgen Macarena | Sevilla | |
Spain | Hospital Universitari i Politecnic La Fe de Valencia | Valencia |
Lead Sponsor | Collaborator |
---|---|
Aimmune Therapeutics, Inc. |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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