CompletedPhase 3

Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)

United States, Canada, France911 participantsStarted 2017-11-02

Plain-language summary

The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.

Who can participate

Age range

1 Year – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Prior participation in an Aimmune AR101 clinical study or any future clinical study that identifies ARC008 as a follow-on study option in the protocol * Written informed consent and/or assent from subjects/guardians as appropriate * Use of effective birth control by sexually active female subjects of childbearing potential Key Exclusion Criteria: * Did not complete a minimum of 3 months of AR101 maintenance therapy if the subject was assigned to AR101 in the parent study * 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 * Discontinued early from the parent study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Timeframe: From first dose of study drug through 30 days after last dose of study drug, up to 59 months

Number of Participants With Premature Discontinuation of AR101 Dosing Due to TEAEs

Timeframe: From first dose of study drug through 30 days after last dose of study drug, up to 59 months

Number of Participants With Premature Discontinuation of AR101 Dosing Due to Chronic/Recurrent Gastrointestinal TEAEs

Timeframe: From first dose of study drug through 30 days after last dose of study drug, up to 59 months

Number of Participants With TEAEs That Led to a Change in Treatment Regimen

Timeframe: From first dose of study drug through 30 days after last dose of study drug, up to 59 months

Number of Participants With TEAEs That Led to Early Withdrawal

Timeframe: From first dose of study drug through 30 days after last dose of study drug, up to 59 months

Number of Participants Who Experienced a Treatment-emergent Anaphylactic Reaction

Trial details

NCT IDNCT03292484

SponsorAimmune Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-27

Results submitted2024-10-10

View on ClinicalTrials.gov More Peanut Allergy trials