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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
AR101 powder
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain
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).
Time frame: 18 months per subject, approximately 30 months for the study
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Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Spain
Hospital Infantil Universitario Niño Jesus
Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Complejo Hospitalario de Navarra
Pamplona, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
...and 1 more locations