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

Primary Purpose

Peanut Allergy

Status
Terminated
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
AR101
Sponsored by
Aimmune Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring 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)

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario Germans Trias i Pujol
  • Corporacio Sanitaria Parc Tauli
  • Hospital Universitario Severo Ochoa
  • Hospital Universitario Vall d'Hebron - PPDS
  • Hospital Infantil Universitario Niño Jesus
  • Hospital Universitario Infanta Leonor
  • Hospital Clinico San Carlos
  • Complejo Hospitalario de Navarra
  • Hospital Universitario de Canarias
  • Hospital Universitario Virgen Macarena
  • Hospital Universitari i Politecnic La Fe de Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group 1 (AR101 Treatment + standard of care)

Group 2 (Standard of Care Treatment)

Arm Description

Subjects receiving AR101 treatment will have 3 consecutive AR101 dosing periods before exiting (completing) the study: initial dose escalation, up dosing, and maintenance.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
October 9, 2018
Last Updated
June 22, 2021
Sponsor
Aimmune Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03703791
Brief Title
Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents
Official Title
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adolescents: Real World, Open Label, Quality of Life Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor terminated study; no impact on overall benefit risk evaluation of AR101
Study Start Date
October 24, 2018 (Actual)
Primary Completion Date
November 23, 2018 (Actual)
Study Completion Date
November 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aimmune Therapeutics, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy
Keywords
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (AR101 Treatment + standard of care)
Arm Type
Active Comparator
Arm Description
Subjects receiving AR101 treatment will have 3 consecutive AR101 dosing periods before exiting (completing) the study: initial dose escalation, up dosing, and maintenance.
Arm Title
Group 2 (Standard of Care Treatment)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
AR101
Intervention Description
AR101 powder
Primary Outcome Measure Information:
Title
Health-related Quality of Life
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Director of Regulatory Affairs
Organizational Affiliation
Aimmune Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
8916
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
8208
Country
Spain
Facility Name
Hospital Universitario Severo Ochoa
City
Leganes
State/Province
Madrid
ZIP/Postal Code
28911
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron - PPDS
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Infantil Universitario Niño Jesus
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28032
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
Santa Cruz de Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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