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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03703791
Other study ID # ARC009
Secondary ID 2018-000326-58
Status Terminated
Phase Phase 3
First received
Last updated
Start date October 24, 2018
Est. completion date November 23, 2018

Study information

Verified date June 2021
Source Aimmune Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
AR101
AR101 powder

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Aimmune Therapeutics, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

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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