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

• ClinicalTrials.gov Identifier: NCT03703791
• Recruitment Status: Terminated
• First Posted: October 12, 2018
• Results First Posted: July 13, 2021
• Last Update Posted: July 13, 2021
• Sponsor: Aimmune Therapeutics, Inc.
• Information provided by (Responsible Party): Aimmune Therapeutics, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Peanut Allergy	Biological: AR101	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adolescents: Real World, Open Label, Quality of Life Study
• Actual Study Start Date: October 24, 2018
• Actual Primary Completion Date: November 23, 2018
• Actual Study Completion Date: November 23, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Health-related Quality of Life [ Time Frame: 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).

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Spain

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, Spain, 8916

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, Spain, 8208

Hospital Universitario Severo Ochoa

Leganes, Madrid, Spain, 28911

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain, 8035

Hospital Infantil Universitario Niño Jesus

Madrid, Spain, 28009

Hospital Universitario Infanta Leonor

Madrid, Spain, 28032

Hospital Clinico San Carlos

Madrid, Spain, 28040

Complejo Hospitalario de Navarra

Pamplona, Spain, 31008

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain, 38320

Hospital Universitario Virgen Macarena

Sevilla, Spain, 41009

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain, 46026

Sponsors and Collaborators

Aimmune Therapeutics, Inc.

Investigators

• Study Director: Director of Regulatory Affairs; Aimmune Therapeutics

  Study Documents (Full-Text)

Documents provided by Aimmune Therapeutics, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] April 11, 2018

More Information

• Responsible Party: Aimmune Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03703791
• Other Study ID Numbers: ARC009; 2018-000326-58 ( EudraCT Number )
• First Posted: October 12, 2018
• Results First Posted: July 13, 2021
• Last Update Posted: July 13, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Aimmune Therapeutics, Inc.:

AR101; Characterized Peanut Allergen (CPNA); (Characterized Peanut Allergen) OIT; Peanut Allergy; Allergy; Peanut-Allergic Children; Peanut-Allergic Adolescents; Desensitization; Quality of Life; OIT (oral immunotherapy); CODIT (TM) Characterized Oral Desensitization Immunotherapy (TM)

Additional relevant MeSH terms:

Hypersensitivity; Peanut Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate