PEANUT ALLERGY STUDY

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 950

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 930
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A subject who meets any of the following criteria is 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, and except during the follow-up observation period in this study
8. Subject is living in the same household or is a dependent of sponsor employee 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 investigational product (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 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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