PEANUT ALLERGY STUDY

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1100

Inclusion Criteria

Subjects must meet all the following criteria to be eligible:
1. Prior participation in one of the following Aimmune AR101 clinical studies: ARC002, ARC004, ARC007, ARC010, ARC011, or any future clinical study that identifies ARC008 as a follow-on study option in the protocol
2. Written informed consent from the subject or parent/guardian 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 1060
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.
2. For subjects treated with AR101 in the parent study requiring a food challenge, failure to successfully consume at least the 300 mg single dose (443 mg cumulative) of peanut protein at parent study's exit food challenge
3. 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 autoimmune diseases and malignancies
4. Subjects with a history of alcohol, illicit or recreational drug or prescribed medication abuse
5. 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
6. Taking a prohibited medication, as listed in Section 5.9.5 of the trial protocol
7. Currently participating in any other interventional clinical study other than the Aimmune parent study
8. Participation in any peanut immunotherapy clinical study, other than Aimmune-sponsored AR101 studies (including oral, sublingual, or epicutaneous), within 5 years prior to Screening, except for Aimmune Studies ARC002, ARC004, ARC007, ARC010 and ARC011
9. 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
10. Except for subjects from ARC002, subjects currently receiving, or having received in the last 5 years, any type of non-peanut allergen immunotherapy (including subcutaneous, sublingual, oral or other)
11. Hypersensitivity to epinephrine or hypersensitivity to any of the excipients in the investigational product (IP)
12. Pregnant or breastfeeding
13. Inability to withhold antihistamines for 5 half-lives prior to initial day of escalation or visits at which a skin prick test (SPT) or open-label food challenge (OLFC) is conducted
14. Discontinued early from the parent study for any safety reason (other than a subject from study ARC004 who has experienced a lack of tolerance for a nondaily dosing regimen)
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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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