Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents

Phase 3

Terminated

• Conditions: Peanut Allergy
• Interventions: Biological: AR101

• Registration Number: NCT03703791
• Lead Sponsor: Aimmune Therapeutics, Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-10-09
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-12
• Study Start: 2018-10-24
• Primary Completion: 2018-11-23
• Study Completion: 2018-11-23
• Results First Submitted: 2021-05-25
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-22
• Last Update Submitted: 2021-06-22
• Results First Posted: 2021-07-13
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (AR101 Treatment + standard of care)	AR101	Subjects receiving AR101 treatment will have 3 consecutive AR101 dosing periods before exiting (completing) the study: initial dose escalation, up dosing, and maintenance.

Primary Outcome Measures

Name	Time	Method
Health-related Quality of Life	18 months per subject, approximately 30 months for the study	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).

Trial Locations

Locations (11)

Corporacio Sanitaria Parc Tauli; 🇪🇸 Sabadell, Barcelona, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Universitario Infanta Leonor; 🇪🇸 Madrid, Spain

Hospital Universitario de Canarias; 🇪🇸 Santa Cruz de Tenerife, Spain

Hospital Universitario Severo Ochoa; 🇪🇸 Leganes, Madrid, Spain

Hospital Infantil Universitario Niño Jesus; 🇪🇸 Madrid, Spain

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Spain

Hospital Universitario Vall d'Hebron - PPDS; 🇪🇸 Barcelona, Spain

Hospital Universitari i Politecnic La Fe de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain