NCT03337542 is a Phase 3 clinical trial of AR101 in Peanut Allergy, sponsored by Aimmune Therapeutics, Inc..

Who is sponsoring NCT03337542?

NCT03337542 is sponsored by Aimmune Therapeutics, Inc..

What drugs are being tested in NCT03337542?

Interventions in NCT03337542: AR101.

What condition does NCT03337542 study?

NCT03337542 studies Peanut Allergy.

Is NCT03337542 still recruiting?

NCT03337542 is currently completed. Last updated 2 November 2021.

Are results published for NCT03337542?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-11-02 · How we verify

NCT03337542

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

AR101 Real-World Open-Label Extension Study

Completed Phase 3 Results posted Last updated 2 November 2021

What this trial tests

Phase 3 trial testing AR101 in Peanut Allergy in 243 participants. Completed in 20 September 2019.

Timeline

18 October 2017

Primary endpoint
20 September 2019

20 September 2019

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	243
Start date	18 October 2017
Primary completion	20 September 2019
Estimated completion	20 September 2019
Sites	60 locations across Canada, United States

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 4 to 17, 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 (Safety and Tolerability) Primary · Approximately 6 months

Number of participants with treatment-emergent adverse events including serious adverse events during the overall study period (safety and tolerability)

Subjects with at least 1 Adverse Event (AE)

Group	Value	95% CI
AR101	219

Mild AE

Group	Value	95% CI
AR101	176

Moderate AE

Group	Value	95% CI
AR101	43

Severe AE

Group	Value	95% CI
AR101	0

Life-threatening AE

Group	Value	95% CI
AR101	0

Death AE

Group	Value	95% CI
AR101	0

Subjects with at least 1 Serious Adverse Event (SAE)

Group	Value	95% CI
AR101	1

Mild SAE

Group	Value	95% CI
AR101	0

Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events Secondary · Approximately 6 months

Group	Value	95% CI
AR101	1

Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events Secondary · Approximately 6 months

Group	Value	95% CI
AR101	1

Percentage of Subjects With Chronic/Recurrent GI Adverse Events Resolving Before 2, Between 2 and 4, Between 4 and 12, and ≥ 12 Weeks After Discontinuation of Dosing Secondary · Approximately 6 months

Group	Value	95% CI
AR101	1
AR101	0
AR101	0
AR101	0

Number of Participants With Allergic Hypersensitivity Adverse Events Secondary · Approximately 6 months

Throat irritation

Group	Value	95% CI
AR101	43

Pruritus

Group	Value	95% CI
AR101	39

Abdominal pain

Group	Value	95% CI
AR101	30

Abdominal discomfort

Group	Value	95% CI
AR101	28

Urticaria

Group	Value	95% CI
AR101	27

Cough

Group	Value	95% CI
AR101	24

Anaphylactic reaction

Group	Value	95% CI
AR101	21

Nausea

Group	Value	95% CI
AR101	19

Number of Participants With of Anaphylaxis as Defined in the Protocol Secondary · Approximately 6 months

Anaphylaxis is likely when any 1 of the 3 following sets of criteria is fulfilled: 1. Acute onset of an illness (minutes to hours) with involvement of: (a) Skin/mucosal tissue (eg, generalized hives, itch/flush, swollen lips/tongue/uvula); AND (b) Airway compromise (eg, dyspnea, stridor, wheeze/bronchospasm, hypoxia, reduced PEFR); AND/OR (c) Reduced BP or associated symptoms (eg, hypotonia, syncope, incontinence). 2. Two or more of the following that occur rapidly after exposure to the allergen (minutes to hours): (a) Skin/mucosal tissue; (b) Airway compromise; (c) Reduced BP or associated s

Group	Value	95% CI
AR101	21

Number of Participants With Epinephrine Use as Rescue Medication Secondary · Approximately 6 months

Group	Value	95% CI
AR101	19

Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods Secondary · Approximately 6 months

Number of participants with accidental/nonaccidental ingestion of peanut (not AR101 or food challenge material) and other allergenic foods.

Group	Value	95% CI
AR101	33

Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11 Secondary · Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months)

The C-ACT for subjects aged 4 to 11 years included 4 questions for the subject and 3 questions for the parent/caregiver; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control).

Baseline

Group	Value	95% CI
AR101	24	± 2.58

Maintenance Visit 1

Group	Value	95% CI
AR101	24.4	± 2.70

Maintenance Visit 2

Group	Value	95% CI
AR101	25.0	± 1.97

Maintenance Visit 3

Group	Value	95% CI
AR101	25.0	± 2.49

Maintenance Visit 4

Group	Value	95% CI
AR101	25.3	± 1.88

Maintenance Visit 5

Group	Value	95% CI
AR101	24.8	± 2.36

Maintenance Visit 6

Group	Value	95% CI
AR101	24.9	± 2.31

Early Discontinuation

Group	Value	95% CI
AR101	26.4	± 0.89

Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17 Secondary · Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months)

The ACT for subjects aged 12 to 17 years consisted of 5 questions, and the total score (sum of 5 questions) ranged from 5 (worst control) to 25 (total control).

Baseline

Group	Value	95% CI
AR101	23.3	± 1.92

Maintenance Visit 1

Group	Value	95% CI
AR101	23.8	± 1.70

Maintenance Visit 2

Group	Value	95% CI
AR101	23.9	± 1.65

Maintenance Visit 3

Group	Value	95% CI
AR101	23.7	± 2.32

Maintenance Visit 4

Group	Value	95% CI
AR101	23.3	± 2.72

Maintenance Visit 5

Group	Value	95% CI
AR101	23.6	± 2.14

Maintenance Visit 6

Group	Value	95% CI
AR101	23.8	± 2.19

Early Discontinuation

Group	Value	95% CI
AR101	21.5	± 4.95

Number of Participants With Adverse Events That Led to Early Withdrawal Secondary · Approximately 6 months

Group	Value	95% CI
AR101	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Arm Description

Serious: 1/242 (0%)

Deaths: 0/242

Serious adverse events (1 terms)

Reaction	System	Treatment Arm Description
Anaphylactic reaction	Immune system disorders	—

Other adverse events (23 terms — click to expand)

Reaction	System	Treatment Arm Description
Cough	Respiratory, thoracic and mediastinal disorders	—
Abdominal discomfort	Gastrointestinal disorders	—
Throat irritation	Respiratory, thoracic and mediastinal disorders	—
Upper respiratory tract infection	Infections and infestations	—
Pruritus	Skin and subcutaneous tissue disorders	—
Vomiting	Gastrointestinal disorders	—
Abdominal pain	Gastrointestinal disorders	—
Urticaria	Skin and subcutaneous tissue disorders	—
Headache	Nervous system disorders	—
Nausea	Gastrointestinal disorders	—
Pyrexia	General disorders	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	—
Rash	Skin and subcutaneous tissue disorders	—
Anaphylactic reaction	Immune system disorders	—
Nasopharyngitis	Infections and infestations	—
Wheezing	Respiratory, thoracic and mediastinal disorders	—
Abdominal pain upper	Gastrointestinal disorders	—
Oral pruritis	Gastrointestinal disorders	—
Viral infection	Infections and infestations	—
Eye pruritus	Eye disorders	—
Sneezing	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Anaphylactic reaction.

Data from ClinicalTrials.gov NCT03337542 adverse events section.

Sponsor's own description

This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.

Publications & conference data

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

Children and caregiver proxy quality of life from peanut oral immunotherapy trials.
Galvin AD, Vereda A, Rodríguez del Río P, Muraro A, et al · · 2022 · cited 17× · PMID 36573312 · DOI 10.1002/clt2.12213
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
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

Verify or expand the search:

Other trials of AR101

Trials testing the same drug.

NCT03703791 — Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents · Phase 3 · terminated
NCT03682770 — Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut · Phase 2 · completed
NCT03292484 — Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008) · Phase 3 · completed
NCT03126227 — Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES) · Phase 3 · completed
NCT02993107 — PALISADE Follow-on Study (ARC004) · Phase 3 · completed

Other recruiting trials for Peanut Allergy

Currently open trials in the same condition.

NCT07349212 — UKK-0018 as an Immunotherapeutic for Treatment of Peanut Allergies · Phase 1, PHASE2 · recruiting
NCT05695261 — Evaluating the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients · Phase 2 · recruiting
NCT05503446 — Using Commonly Available Food Products To Treat Food Allergy · NA · active not recruiting
NCT05667610 — Immune-supportive Diet and Gut Permeability in Allergic Children · NA · recruiting
NCT06256146 — Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety · NA · recruiting

Other Aimmune Therapeutics, Inc. trials

Trials by the same sponsor.

NCT04056299 — Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy · Phase 2 · terminated
NCT03736447 — Peanut Oral Immunotherapy Study of Early Intervention for Desensitization · Phase 3 · completed
NCT03703791 — Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents · Phase 3 · terminated
NCT03292484 — Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008) · Phase 3 · completed
NCT03201003 — ARTEMIS Peanut Allergy In Children · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03337542 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Aimmune Therapeutics, Inc.
Last refreshed: 2 November 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03337542.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing