NCT03292484

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

Completed Phase 3 Results posted Last updated 19 December 2024

What this trial tests

Phase 3 trial testing AR101 in Peanut Allergy in 911 participants. Completed in 27 April 2023.

Timeline

2 November 2017

Primary endpoint
27 April 2023

27 April 2023

Quick facts

Lead sponsor	Aimmune Therapeutics, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	911
Start date	2 November 2017
Primary completion	27 April 2023
Estimated completion	27 April 2023
Sites	93 locations across France, Italy, Netherlands, Sweden, Ireland, United Kingdom, Germany, Canada

Drugs / interventions tested

• AR101 — full drug profile →

Conditions studied

• Peanut Allergy — all drugs for Peanut Allergy →

Sponsor

Aimmune Therapeutics, Inc. — full company profile →

Who can join

Adults 1 to 55, any sex, with Peanut Allergy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Primary · From first dose of study drug through 30 days after last dose of study drug, up to 59 months

An AE was any untoward medical occurrence in humans, whether or not considered related to the investigational product (IP), that occurred during the conduct of a clinical study. A SAE was any event that resulted in any of the following: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital abnormality or birth defect, or important medical event that did not result in one of the above outcomes, but jeopardized the health of the s

TEAEs

Group	Value	95% CI
AR101	866

TESAEs

Group	Value	95% CI
AR101	42

Number of Participants With Premature Discontinuation of AR101 Dosing Due to TEAEs Primary · From first dose of study drug through 30 days after last dose of study drug, up to 59 months

An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug.

Group	Value	95% CI
AR101	53

Number of Participants With Premature Discontinuation of AR101 Dosing Due to Chronic/Recurrent Gastrointestinal TEAEs Primary · From first dose of study drug through 30 days after last dose of study drug, up to 59 months

An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug. Gastrointestinal (GI) AEs, typically chronic/recurrent GI AEs, that resulted in prolonged interruption of dosing are reported.

Group	Value	95% CI
AR101	25

Number of Participants With TEAEs That Led to a Change in Treatment Regimen Primary · From first dose of study drug through 30 days after last dose of study drug, up to 59 months

An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug. Number of participants with TEAEs requiring dose interruption and dose reduction of study treatment are reported.

TEAEs requiring dose interruption of study treatment

Group	Value	95% CI
AR101	669

TEAEs requiring dose reduction of study treatment

Group	Value	95% CI
AR101	167

Number of Participants With TEAEs That Led to Early Withdrawal Primary · From first dose of study drug through 30 days after last dose of study drug, up to 59 months

An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. TEAEs were defined as those AEs with onset after the first dose of AR101 in ARC008 and no more than 30 days after the last dose of study drug.

Group	Value	95% CI
AR101	27

Number of Participants Who Experienced a Treatment-emergent Anaphylactic Reaction Primary · From first dose of study drug through 30 days after last dose of study drug, up to 59 months

Anaphylaxis was defined by a number of signs and symptoms that occurred alone or in combination within minutes up to a few hours after exposure to a provoking agent. Treatment-emergent anaphylactic reactions included anaphylactic reactions that occurred after first dose of AR101 in ARC008 through 30 days after last dose of study product but excluding anaphylactic reactions that occurred during or related to a food challenge.

Group	Value	95% CI
AR101	192

Number of Participants With Use of Epinephrine as a Rescue Medication Primary · From first dose of study drug through 30 days after last dose of study drug, up to 59 months

Rescue medications were any medication used to treat individual acute allergic reactions during ARC008 and were according to recognized standards of care for allergy practice.

Group	Value	95% CI
AR101	234

Number of Participants Who Experienced Accidental or Non-accidental Food Allergy Episodes Primary · From first dose of study drug through 30 days after last dose of study drug, up to 59 months

An accidental food allergen exposure was any known or suspected exposure to a food to which the participant was allergic, including peanut, whether or not it resulted in an AE. A non-accidental food allergen exposure was an intentional exposure to a food to which the participant was allergic, including peanut, whether or not it resulted in an AE. Treatment-emergent food allergy episodes included food allergy episodes that occurred after first dose of AR101 in ARC008 through 30 days after last dose of study product but excluding food allergy episodes that occurred during or related to a food ch

Accidental Food Allergy Episodes

Group	Value	95% CI
AR101	208

Non-accidental Food Allergy Episodes

Group	Value	95% CI
AR101	35

Number of Participants With TEAEs Following Accidental or Non-accidental Exposure to Peanut and Other Allergenic Foods Primary · From first dose of study drug through 30 days after last dose of study drug, up to 59 months

An accidental food allergen exposure was any known or suspected exposure to a food to which the participant was allergic, including peanut, whether or not it resulted in an AE. A non-accidental food allergen exposure was an intentional exposure to a food to which the participant was allergic, including peanut, whether or not it resulted in an AE. An AE was any untoward medical occurrence in humans, whether or not considered related to the IP, that occurred during the conduct of a clinical study. Treatment-emergent food allergy episodes included food allergy episodes that occurred after first d

Group	Value	95% CI
AR101	227

Number of Participants With Eosinophilic Esophagitis (EoE) Primary · From first dose of study drug through 30 days after last dose of study drug, up to 59 months

EoE was diagnosed by biopsy/endoscopy.

Group	Value	95% CI
AR101	7

Percentage of Participants Tolerating Each Challenge Dose in the Open-label Food Challenge (OLFC) and the Double-blind, Placebo-Controlled Food Challenge (DBPCFC) Secondary · OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)

During the OLFC, single doses (300, 600, 1000, and 2000 mg) of peanut protein were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals. During the DBPCFC, single doses (3, 10, 30, 100, 300, 600, 1000, and 2000 mg) of peanut protein and placebo were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals up to a single highest challenge dose of 2000 mg.

OLFC: Tolerated a single highest dose of at least 300 mg

Group	Value	95% CI
AR101	98.6	97.2 – 99.5

OLFC: Tolerated a single highest dose of at least 600 mg

Group	Value	95% CI
AR101	94.2	91.8 – 96.1

OLFC: Tolerated a single highest dose of at least 1000 mg

Group	Value	95% CI
AR101	78.7	74.9 – 82.2

OLFC: Tolerated a single highest dose of at least 2000 mg

Group	Value	95% CI
AR101	55.9	51.5 – 60.2

DBPCFC: Tolerated a single highest dose of at least 3 mg

Group	Value	95% CI
AR101	100.0	98.3 – 100.0

DBPCFC: Tolerated a single highest dose of at least 10 mg

Group	Value	95% CI
AR101	100.0	98.3 – 100.0

DBPCFC: Tolerated a single highest dose of at least 30 mg

Group	Value	95% CI
AR101	99.5	97.4 – 100.0

DBPCFC: Tolerated a single highest dose of at least 100 mg

Group	Value	95% CI
AR101	99.1	96.6 – 99.9

Maximum Tolerated Challenge Dose at Each Food Challenge Secondary · OLFC: At Month 12 and yearly thereafter, up to 58 months; DBPCFC: End of treatment (Month 58)

The maximum tolerated challenge dose for a food challenge was defined as the maximum single dose of peanut protein resulting in no more than mild symptoms and assessed by the investigator to have been tolerated (i.e., the participant did not experience any dose-limiting symptoms). During the OLFC, single doses (300, 600, 1000, and 2000 mg) of peanut protein were conditionally tested using a food challenge mixture administered sequentially at 20- to 30-minute intervals. During the DBPCFC, single doses (3, 10, 30, 100, 300, 600, 1000, and 2000 mg) of peanut protein and placebo were conditionally

OLFC

Group	Value	95% CI
AR101	2000

DBPCFC

Group	Value	95% CI
AR101	2000

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug through 30 days after last dose of study drug, up to 59 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AR101

Serious: 42/908 (5%)

Deaths: 0/908

Serious adverse events (33 terms)

Reaction	System	AR101
Appendicitis	Infections and infestations	—
Anaphylactic reaction	Immune system disorders	—
Asthma	Respiratory, thoracic and mediastinal disorders	—
Croup infectious	Infections and infestations	—
Abdominal pain	Gastrointestinal disorders	—
Concussion	Injury, poisoning and procedural complications	—
Enterovirus infection	Infections and infestations	—
Gastroenteritis	Infections and infestations	—
Gastroenteritis viral	Infections and infestations	—
Influenza	Infections and infestations	—
Meningitis	Infections and infestations	—
Meningitis viral	Infections and infestations	—
Pneumonia	Infections and infestations	—
Pneumonia mycoplasmal	Infections and infestations	—
Rhinovirus infection	Infections and infestations	—
Salmonella bacteraemia	Infections and infestations	—
Sinusitis	Infections and infestations	—
Viral infection	Infections and infestations	—
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	—
Atelectasis	Respiratory, thoracic and mediastinal disorders	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—
Wheezing	Respiratory, thoracic and mediastinal disorders	—
Coeliac disease	Gastrointestinal disorders	—
Constipation	Gastrointestinal disorders	—

Other adverse events (47 terms — click to expand)

Reaction	System	AR101
Cough	Respiratory, thoracic and mediastinal disorders	—
Vomiting	Gastrointestinal disorders	—
Pyrexia	General disorders	—
Abdominal pain	Gastrointestinal disorders	—
Urticaria	Skin and subcutaneous tissue disorders	—
Headache	Nervous system disorders	—
Nasopharyngitis	Infections and infestations	—
Upper respiratory tract infection	Infections and infestations	—
Pruritus	Skin and subcutaneous tissue disorders	—
Anaphylactic reaction	Immune system disorders	—
Nausea	Gastrointestinal disorders	—
Abdominal pain upper	Gastrointestinal disorders	—
Throat irritation	Respiratory, thoracic and mediastinal disorders	—
Abdominal discomfort	Gastrointestinal disorders	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—
Viral infection	Infections and infestations	—
Diarrhoea	Gastrointestinal disorders	—
Rash	Skin and subcutaneous tissue disorders	—
Sneezing	Respiratory, thoracic and mediastinal disorders	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—
Influenza	Infections and infestations	—
Wheezing	Respiratory, thoracic and mediastinal disorders	—
COVID-19	Infections and infestations	—
Gastroenteritis viral	Infections and infestations	—
Gastroenteritis	Infections and infestations	—
Oral pruritus	Gastrointestinal disorders	—
Asthma	Respiratory, thoracic and mediastinal disorders	—
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	—
Eye pruritus	Eye disorders	—
Rhinitis	Infections and infestations	—
Eczema	Skin and subcutaneous tissue disorders	—
Lip swelling	Gastrointestinal disorders	—
Erythema	Skin and subcutaneous tissue disorders	—
Illness	General disorders	—
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	—
Paraesthesia oral	Gastrointestinal disorders	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—
Conjunctivitis	Infections and infestations	—
Pharyngitis streptococcal	Infections and infestations	—

Most-reported serious reactions: Appendicitis, Anaphylactic reaction, Asthma, Croup infectious, Abdominal pain, Concussion, Enterovirus infection, Gastroenteritis.

Data from ClinicalTrials.gov NCT03292484 adverse events section.

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy.
   Fernandez-Rivas M, Vereda A, Vickery BP, Sharma V, et al · · 2022 · cited 50× · PMID 34320250 · DOI 10.1111/all.15027
2. Recent advances in mechanisms of food allergy and anaphylaxis.
   Tomar S, Hogan SP. · · 2020 · cited 8× · PMID 32789004 · DOI 10.12688/f1000research.25638.1
3. Long-term safety and immunologic outcomes of daily oral immunotherapy for peanut allergy.
   Bird JA, Nilsson C, Brown K, Pham T, et al · · 2023 · cited 5× · PMID 37779517 · DOI 10.1016/j.jacig.2023.100120
4. The Etiology of IgE-Mediated Food Allergy: Potential Therapeutics and Challenges.
   Carnazza M, Werner R, Tiwari RK, Geliebter J, et al · · 2025 · cited 3× · PMID 40004029 · DOI 10.3390/ijms26041563