Clinical trial NCT03703791: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: 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)
Lead sponsor: Aimmune Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-12
Enrollment: 1
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Health-related Quality of Life
timeFrame: 18 months per subject, approximately 30 months for the study
Secondary outcomes:
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
city: Leganes
country: Spain
facility: Hospital Universitario Severo Ochoa
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron - PPDS
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesus
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
Study officials:
affiliation: Aimmune Therapeutics
name: Director of Regulatory Affairs
role: STUDY_DIRECTOR
References: