CompletedPhase 3

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

United States911 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 range1 Year – 55 Years

SexALL

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

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

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

Trial details

NCT IDNCT03292484

SponsorAimmune Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-27

Results submitted2024-10-10

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