Study Stopped
Sponsor terminated study; no impact on overall benefit risk evaluation of AR101
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
2 other identifiers
interventional
1
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2018
Shorter than P25 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2018
CompletedFirst Posted
Study publicly available on registry
October 12, 2018
CompletedStudy Start
First participant enrolled
October 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2018
CompletedResults Posted
Study results publicly available
July 13, 2021
CompletedJuly 13, 2021
June 1, 2021
1 month
October 9, 2018
May 25, 2021
June 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Group 1 (AR101 Treatment + standard of care)
ACTIVE COMPARATORSubjects receiving AR101 treatment will have 3 consecutive AR101 dosing periods before exiting (completing) the study: initial dose escalation, up dosing, and maintenance.
Group 2 (Standard of Care Treatment)
NO INTERVENTIONSubjects 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 8916, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, 8208, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28911, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 8035, Spain
Hospital Infantil Universitario Niño Jesus
Madrid, 28009, Spain
Hospital Universitario Infanta Leonor
Madrid, 28032, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Complejo Hospitalario de Navarra
Pamplona, 31008, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, 38320, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Regulatory Affairs
- Organization
- Aimmune Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
Director of Regulatory Affairs
Aimmune Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2018
First Posted
October 12, 2018
Study Start
October 24, 2018
Primary Completion
November 23, 2018
Study Completion
November 23, 2018
Last Updated
July 13, 2021
Results First Posted
July 13, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share