Peanut Allergy
Conditions
Sponsors
Aimmune Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the long-term safety and tolerability of AR101 using a CODIT™ regimen administered to peanut-allergic children and adults;Secondary Objective: - To assess the level of desensitization achievable through extended maintenance 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' QoL and treatment satisfaction during AR101 treatment on daily and nondaily treatment regimens - To evaluate parent/guardian QoL during the child's treatment with AR101 - To evaluate the long-term immunologic effects of AR101 on immune parameters - To characterize the effect of AR101 on basophil activation;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 of the trial protocol) - Frequency of use of epinephrine as a rescue medication - Frequency of accidental ingestion of peanut and other allergenic foods - Frequency of Adverse Events following accidental exposure to peanut and other allergenic foods - Frequency of eosinophilic esophagitis (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) - Proportion of subjects who tolerate the oral real-world peanut challenge (RWPC) - The maximum tolerated challenge dose at each OLFC - Change in tolerated dose of peanut protein - Maximum severity of symptoms in each OLFC - Maximum severity of symptoms in each RWPC - Frequency of use of epinephrine as a rescue medication during the OLFCs - Frequency of use of epinephrine as a rescue medication during the RWPCs - 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 rate (PEFR) - 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’ 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 questionnaire (FAQLQ), and the Food Allergy Independent Measure (FAIM) questionnaire Objective: To evaluate parent/guardian QoL during the child’s treatment with AR101 - Change in Food Allergy Quality of Life – Parental Burden (FAQL-PB) questionnaire score Objective: To evaluate the long-term immunologic effects of AR101 on immune parameters - Change in peanut-specific and peanut component-specific serum immunoglobulin G subclass 4 (IgG4) - Change in peanut-specific and peanut component-specific serum immunoglobulin E (IgE) Objective: To characterize the effect of AR101 on basophil activation - Change in percent activated basophils;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Canada, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactRegulatory Affairs
Aimmune Therapeutics UK Ltd
Outcome results
None listed