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

Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adolescents: Real World, Open Label, Quality of Life Study

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.

Study Overview

• Status: Terminated
• Conditions: Peanut Allergy
• Intervention / Treatment: Biological: AR101

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 8035
    • Hospital Universitario Vall d'Hebron - PPDS
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28009
    • Hospital Infantil Universitario Nino Jesus
  • Madrid, Spain, 28032
    • Hospital Universitario Infanta Leonor
  • Pamplona, Spain, 31008
    • Complejo Hospitalario de Navarra
  • Santa Cruz de Tenerife, Spain, 38320
    • Hospital Universitario de Canarias
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe de Valencia
  • Barcelona
    • Badalona, Barcelona, Spain, 8916
      • Hospital Universitario Germans Trias i Pujol
    • Sabadell, Barcelona, Spain, 8208
      • Corporacio Sanitaria Parc Tauli
  • Madrid
    • Leganes, Madrid, Spain, 28911
      • Hospital Universitario Severo Ochoa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 (AR101 Treatment + standard of care); Subjects receiving AR101 treatment will have 3 consecutive AR101 dosing periods before exiting (completing) the study: initial dose escalation, up dosing, and maintenance.	Biological: AR101; AR101 powder
No Intervention: Group 2 (Standard of Care Treatment); Subjects receiving standard of care alone will have approximately 18 months of observation before study exit, with an OLFC (open label food challenge) approximately 12 months after randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aimmune Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2018
• Primary Completion (Actual): November 23, 2018
• Study Completion (Actual): November 23, 2018

Study Registration Dates

• First Submitted: October 9, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Quality of Life; Allergy; Peanut Allergy; AR101; Characterized Peanut Allergen (CPNA); (Characterized Peanut Allergen) OIT; Peanut-Allergic Children; Peanut-Allergic Adolescents; Desensitization; OIT (oral immunotherapy); CODIT (TM) Characterized Oral Desensitization Immunotherapy (TM)
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: ARC009; 2018-000326-58 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes