Peanut Allergy
Conditions
Sponsors
Aimmune Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 6. Currently participating in any other interventional clinical study other than the Aimmune parent 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 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 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 OLFC 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the long-term safety and tolerability of an AR101 characterized oral desensitization immunotherapy (CODIT) regimen administered to peanut-allergic children and adults;Secondary Objective: - To assess the level of desensitization achievable through extended maintenance dosing of AR101 - To characterize the interaction of AR101 and asthma control or nasal allergy symptoms in subjects with a history of asthma and/or allergic rhinitis - To evaluate subjects' quality of life (QoL) and treatment satisfaction during AR101 treatment on daily and nondaily treatment regimens - To evaluate parent/caregiver QoL during the child's treatment with AR101;Primary end point(s): • Frequency of Adverse Events • Frequency of premature discontinuation of AR101 dosing due to Adverse Events • Frequency of premature discontinuation of dosing due to chronic/recurrent GI Adverse Events • Frequency of Adverse Events that lead to a change in treatment regimen • Frequency of Adverse Events that lead to early withdrawal • Frequency of anaphylaxis (as defined in Section 8.1.4.1) • Frequency of use of epinephrine as a rescue medication • Frequency of accidental/nonaccidental ingestion of peanut and other allergenic foods • Frequency of Adverse Events following accidental/nonaccidental exposure to peanut and other allergenic foods • Frequency of EoE;Timepoint(s) of evaluation of this end point: Interim data analyses may be performed as needed to summarize safety data | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Objective: To assess the level of desensitization achievable through extended maintenance dosing of AR101 • Proportion of subjects tolerating each challenge dose in the open-label food challenge (OLFC) • The maximum tolerated challenge dose at each OLFC • Change in tolerated dose of peanut protein • Maximum severity of symptoms in each OLFC • Frequency of use of epinephrine as a rescue medication during the OLFCs • Change in peanut skin prick test (SPT) mean wheal diameter Objective: To characterize the interaction of AR101 and asthma control or nasal allergy symptoms in subjects with a history of asthma and/or allergic rhinitis • Change in peak expiratory flow (PEF) • Change in Childhood Asthma Control Test (C-ACT) and Asthma Control Test (ACT) score • Change in Total Nasal Symptom Score (TNSS) Objective: To evaluate subjects’ quality of life (QoL) and treatment satisfaction during AR101 treatment on daily and nondaily treatment regimens • Changes in food allergy QoL scores as measured by Food Allergy Quality of Life Questionnaires (FAQLQ), and the Food Allergy Independent Measure (FAIM) questionnaire Objective: To evaluate parent/caregiver QoL during the child’s treatment with AR101 • Change in Food Allergy Quality of Life – Parental Burden (FAQL-PB) questionnaire score;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Canada, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactRegulatory Affairs
Aimmune Therapeutics UK Ltd
Outcome results
None listed