A Multicenter, Open-Label, Longer-Term Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 3

Inclusion Criteria

A subject must meet all the following criteria to be eligible:
1. Prior participation in one of the following Aimmune AR101 clinical studies:
ARC002, ARC004, ARC005, ARC007, ARC010, ARC011, or any future clinical study of
that identifies ARC008 as a follow-on study option in the protocol
2. Written informed consent from the subject or guardian/parent (or both
parents where required by local authorities) in accordance with local
institutional review board (IRB)/ethics committee (EC) guidelines
3. Written assent from the subject as required by local IRB/EC guidelines
4. Use of effective birth control by sexually active females of childbearing
potential

Exclusion Criteria

Subjects who meet any of the following criteria are not eligible:
1. Did not complete a minimum of 3 months of AR101 Maintenance in the parent
study if subject was assigned to AR101 in that study, except for subjects in
ARC004 who did not tolerate the nondaily AR101 dosing regimen, subjects in
ARC007 or ARC010, or unless specified otherwise in the parent study
2. 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, including malignancies
occurring within 5 years prior to Screening and clinically active autoimmune
diseases
3. Subjects with a history of alcohol, illicit or recreational drug or
prescribed medication abuse
4. Developed a clinically significant change in health status during the parent
study that, in the opinion of the investigator, would make the subject
unsuitable for participation in this study
5. Taking a prohibited medication, as listed in Section 5.9.5, except during
the follow-up observation period in this study
6. Currently participating in any other interventional clinical study other
than the Aimmune parent study, except during the follow-up observation period
in this study
7. Currently receiving or received within 5 years prior to Screening any type
of peanut or other food allergen immunotherapy, except AR101 or unless allowed
in the parent study, except during the follow-up observation period in this
study
8. Subject is living in the same household or is a dependent of sponsor
employees and/or site staff involved in conducting this study, except for
subjects originating from Aimmune Studies ARC002, ARC004, ARC007, ARC010, and
ARC011
9. Currently in the build-up phase of immunotherapy for any non-food allergen,
except during the follow-up observation period in this study
10. Hypersensitivity to epinephrine or hypersensitivity to any of the
excipients in the IP
11. Pregnant or breastfeeding
12. Inability to withhold antihistamines for 5 half-lives prior to the initial
day of escalation or visits at which an SPT or food challenge is conducted
13. Discontinued early from the parent study for any safety reason, except a
subject from study ARC004 who has experienced a lack of tolerance for a
nondaily dosing regimen, and subjects who discontinued early from an eligible
parent study due to AEs (including chronic or recurrent GI AEs) who require
continued safety follow-up only
14. Currently committed to an institution (eg, psychiatric institution, prison)
by virtue of an order issued by judicial or administrative
authorities.
15. Any other condition that, in the opinion of the investigator, precludes
participation for reasons of safety
16. Subjects unable to follow the protocol requirements

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints are:<br /><br>• Frequency of adverse events (AEs)<br /><br>• Frequency of premature discontinuation of AR101 dosing due to AEs<br /><br>• Frequency of premature discontinuation of dosing due to chronic/recurrent<br /><br>gastrointestinal (GI) AEs<br /><br>• Frequency of AEs that lead to a change in treatment regimen<br /><br>• Frequency of AEs that lead to early withdrawal<br /><br>• Frequency of anaphylaxis (as defined in Section 8.1.4.1)<br /><br>• Frequency of use of epinephrine as a rescue medication<br /><br>• Frequency of accidental/nonaccidental ingestion of peanut and other<br /><br>allergenic foods<br /><br>• Frequency of AEs following accidental/nonaccidental exposure to peanut and<br /><br>other allergenic foods<br /><br>• Frequency of eosinophilic esophagitis (EoE)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include:<br /><br>• Proportion of subjects tolerating each challenge dose in the open-label food<br /><br>challenge (OLFC) and the double-blind, placebo-controlled food challenge<br /><br>(DBPCFC)<br /><br>• The maximum tolerated challenge dose at each food challenge<br /><br>• Change in tolerated dose of peanut protein<br /><br>• Maximum severity of symptoms in each food challenge<br /><br>• Frequency of use of epinephrine as a rescue medication during the food<br /><br>challenges<br /><br>• Change in peak expiratory flow (PEF)<br /><br>• Change in Childhood Asthma Control Test (C-ACT) and Asthma Control Test (ACT)<br /><br>score<br /><br>• Change in Total Nasal Symptom Score (TNSS)<br /><br>• Changes in food allergy QoL scores as measured by Food Allergy Quality of<br /><br>Life Questionnaires (FAQLQ), and the Food Allergy Independent Measure (FAIM)<br /><br>questionnaire<br /><br>• Change in Food Allergy Quality of Life - Parental Burden (FAQL-PB)<br /><br>questionnaire score</p><br>