Phase 3
Completed N=911
Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)
Peanut Allergy
Source: ClinicalTrials.gov NCT03292484 ↗
Enrolled (actual)
911
Serious AEs
4.6%
Results posted
Dec 2024
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) — 866; 42 Participants
◆ Published Evidence
Established
69citations · ~17 / year
Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy.
Summary
The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.
Linked Publications (2)
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Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy.
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Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
866; 42 | — |
| PRIMARY Number of Participants With Premature Discontinuation of AR101 Dosing Due to TEAEs |
53 | — |
| PRIMARY Number of Participants With Premature Discontinuation of AR101 Dosing Due to Chronic/Recurrent Gastrointestinal TEAEs |
25 | — |
| PRIMARY Number of Participants With TEAEs That Led to a Change in Treatment Regimen |
669; 167 | — |
| PRIMARY Number of Participants With TEAEs That Led to Early Withdrawal |
27 | — |
| PRIMARY Number of Participants Who Experienced a Treatment-emergent Anaphylactic Reaction |
192 | — |
| PRIMARY Number of Participants With Use of Epinephrine as a Rescue Medication |
234 | — |
| PRIMARY Number of Participants Who Experienced Accidental or Non-accidental Food Allergy Episodes |
208; 35 | — |
| PRIMARY Number of Participants With TEAEs Following Accidental or Non-accidental Exposure to Peanut and Other Allergenic Foods |
227 | — |
| PRIMARY Number of Participants With Eosinophilic Esophagitis (EoE) |
7 | — |
| SECONDARY Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC) |
98.6; 94.2; 78.7; 55.9; 100.0; 100.0 | — |
| SECONDARY Maximum Tolerated Challenge Dose at Each Food Challenge |
2000; 2000 | — |
| SECONDARY Number of Participants With Use of Epinephrine as a Rescue Medication During the Food Challenges |
110; 35 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03292484) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.