Phase 3
N=911
Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)
Peanut Allergy
Bottom Line
View on ClinicalTrials.gov: NCT03292484 ↗Enrolled (actual)
911
Serious AEs
4.6%
Results posted
Dec 2024
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) — 866; 42 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AR101 (Biological)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- Aimmune Therapeutics, Inc.
- Primary completion
- Apr 2023
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 | — |
Summary
The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.
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). 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.