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

Aimmune Therapeutics

Status and phase: Terminated; Phase 3

Conditions: Peanut Allergy

Treatments: Biological: AR101

Study type: Interventional

Funder types: Industry

Identifiers

NCT03703791

ARC009

2018-000326-58 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Group 1 (AR101 Treatment + standard of care)

Active Comparator group

Description:

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

Treatment:

Biological: AR101

Group 2 (Standard of Care Treatment)

No Intervention group

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.