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

Peanut Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03703791
• Other study ID #: ARC009
• Secondary ID: 2018-000326-58
• Status: Terminated
• Phase: Phase 3
• Start date: October 24, 2018
• Est. completion date: November 23, 2018

Study information

• Verified date: June 2021
• Source: Aimmune Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 23, 2018
• Est. primary completion date: November 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Biological:
• AR101
AR101 powder

Locations

Country	Name	City	State
Spain	Hospital Universitario Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Universitario Vall d'Hebron - PPDS	Barcelona
Spain	Hospital Universitario Severo Ochoa	Leganes	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Infantil Universitario Niño Jesus	Madrid
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Complejo Hospitalario de Navarra	Pamplona
Spain	Corporacio Sanitaria Parc Tauli	Sabadell	Barcelona
Spain	Hospital Universitario de Canarias	Santa Cruz de Tenerife
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Aimmune Therapeutics, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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