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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-24

Study Completion Date

2018-11-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peanut Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 (AR101 Treatment + standard of care)

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

Group Type ACTIVE_COMPARATOR

AR101

Intervention Type BIOLOGICAL

AR101 powder

Group 2 (Standard of Care Treatment)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AR101

AR101 powder

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

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

Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No