NCT01987817 (ARC001) is a Phase 2 clinical trial of AR101 powder provided in capsules in Peanut Allergy, sponsored by Aimmune Therapeutics, Inc..

Who is sponsoring NCT01987817?

NCT01987817 is sponsored by Aimmune Therapeutics, Inc..

What drugs are being tested in NCT01987817?

Interventions in NCT01987817: AR101 powder provided in capsules, Placebo powder provided in capsules.

What condition does NCT01987817 study?

NCT01987817 studies Peanut Allergy.

Is NCT01987817 still recruiting?

NCT01987817 is currently completed. Last updated 30 November 2021.

Are results published for NCT01987817?

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

Last reviewed 2021-11-30 · How we verify

NCT01987817: ARC001

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

Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT

Completed Phase 2 Results posted Last updated 30 November 2021

What this trial tests

Phase 2 trial testing AR101 powder provided in capsules in Peanut Allergy in 56 participants. Completed in 7 January 2015.

Timeline

6 February 2014

Primary endpoint
7 January 2015

7 January 2015

Quick facts

Lead sponsor	Aimmune Therapeutics, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	56
Start date	6 February 2014
Primary completion	7 January 2015
Estimated completion	7 January 2015
Sites	8 locations across United States

Drugs / interventions tested

AR101 powder provided in capsules — full drug profile →
Placebo powder provided in capsules — 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 26, 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.

The Percentage of Subjects Who Tolerate at Least 300 mg (443 mg Cumulative) of Peanut Protein With no More Than Mild Symptoms at the Exit DBPCFC Primary · 6-9 Months

The primary endpoint was the percentage of subjects who achieved desensitization, as determined by tolerating at least 300 mg (443 mg cumulative) of peanut protein at the Exit Double Blind Placebo Controlled Food Challenge (DBPCFC) with no more than mild symptoms (i.e., desensitization responders)

Group	Value	95% CI
AR101 Powder Provided in Capsules	23
Placebo Powder Provided in Capsules	5

Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC Secondary · 6-9 months

The change in maximum tolerated dose of peanut protein from baseline (screening) to the Exit Double-Blind, Placebo-Controlled Food Challenge

Group	Value	95% CI
AR101 Powder Provided in Capsules	1.254	0.984 – 1.523
Placebo Powder Provided in Capsules	0.341	0.057 – 0.626

Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC Secondary · 6-9 months

0.3 mg

Group	Value	95% CI
AR101 Powder Provided in Capsules	0
Placebo Powder Provided in Capsules	1

3 mg

Group	Value	95% CI
AR101 Powder Provided in Capsules	2
Placebo Powder Provided in Capsules	2

10 mg

Group	Value	95% CI
AR101 Powder Provided in Capsules	3
Placebo Powder Provided in Capsules	7

30 mg

Group	Value	95% CI
AR101 Powder Provided in Capsules	1
Placebo Powder Provided in Capsules	5

100 mg

Group	Value	95% CI
AR101 Powder Provided in Capsules	0
Placebo Powder Provided in Capsules	6

300 mg

Group	Value	95% CI
AR101 Powder Provided in Capsules	5
Placebo Powder Provided in Capsules	5

600 mg

Group	Value	95% CI
AR101 Powder Provided in Capsules	18
Placebo Powder Provided in Capsules	0

Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC Secondary · 6-9 months

Peanut-Specific IgE, Baseline

Group	Value	95% CI
AR101 Powder Provided in Capsules	32.571	18.626 – 56.957
Placebo Powder Provided in Capsules	53.839	34.952 – 82.934

Peanut-Specific IgE, Exit

Group	Value	95% CI
AR101 Powder Provided in Capsules	36.889	21.258 – 64.015
Placebo Powder Provided in Capsules	57.060	37.186 – 87.557

Relative Change From Baseline of Peanut-Specific IgGE

Group	Value	95% CI
AR101 Powder Provided in Capsules	1.231	1.027 – 1.475
Placebo Powder Provided in Capsules	1.060	1.001 – 1.122

Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC Secondary · 6-9 months

Peanut-Specific IgG4, Baseline

Group	Value	95% CI
AR101 Powder Provided in Capsules	0.734	0.487 – 1.107
Placebo Powder Provided in Capsules	0.510	0.344 – 0.757

Peanut-Specific IgG4, Exit

Group	Value	95% CI
AR101 Powder Provided in Capsules	3.609	2.074 – 6.281
Placebo Powder Provided in Capsules	0.540	0.377 – 0.775

Relative Change From Baseline of Peanut-Specific IgG4

Group	Value	95% CI
AR101 Powder Provided in Capsules	5.068	3.640 – 7.055
Placebo Powder Provided in Capsules	1.066	0.905 – 1.255

Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline Secondary · Baseline, 6-9 months

Peanut Wheal, Baseline (mm)

Group	Value	95% CI
AR101 Powder Provided in Capsules	14.1	11.6 – 16.7
Placebo Powder Provided in Capsules	13.7	11.4 – 16.0

Peanut Wheal, Exit (mm)

Group	Value	95% CI
AR101 Powder Provided in Capsules	7.1	5.7 – 8.6
Placebo Powder Provided in Capsules	11.8	9.3 – 14.4

Change in Peanut Wheel from Baseline (mm)

Group	Value	95% CI
AR101 Powder Provided in Capsules	-7.0	-9.9 – -4.1
Placebo Powder Provided in Capsules	-1.8	-4.8 – -1.1

Adverse events — posted to ClinicalTrials.gov

Time frame: 6-9 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AR101 Powder Provided in Capsules

Serious: 1/29 (3%)

Deaths: 0/29

Placebo Powder Provided in Capsules

Serious: 1/26 (4%)

Deaths: 0/26

Serious adverse events (1 terms)

Reaction	System	AR101 Powder Provided in C…	Placebo Powder Provided in…
Hypersensitivity	Immune system disorders	—	—

Other adverse events (55 terms — click to expand)

Reaction	System	AR101 Powder Provided in C…	Placebo Powder Provided in…
Hypersensitivity	Immune system disorders	—	—
Upper Respiratory Tract Infection	Infections and infestations	—	—
Pyrexia	General disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Viral Infection	Infections and infestations	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Headache	Nervous system disorders	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—
Pharyngitis streptococcal	Infections and infestations	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Somnolence	Nervous system disorders	—	—
Malaise	General disorders	—	—
Ligament sprain	Injury, poisoning and procedural complications	—	—
Ear pain	Ear and labyrinth disorders	—	—
Croup Infectious	Infections and infestations	—	—
Ear infection	Infections and infestations	—	—
Ear lobe infection	Infections and infestations	—	—
Gastroenteritis	Infections and infestations	—	—
Gastroenteritis viral	Infections and infestations	—	—
Molluscum contagiosum	Infections and infestations	—	—
Nasopharyngitis	Infections and infestations	—	—
Otitis externa	Infections and infestations	—	—
Tinea infection	Infections and infestations	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—
Dental caries	Gastrointestinal disorders	—	—
Toothache	Gastrointestinal disorders	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—
Throat irritation	Respiratory, thoracic and mediastinal disorders	—	—
Presyncope	Nervous system disorders	—	—
Dizziness	Nervous system disorders	—	—
Arthropod stings	Injury, poisoning and procedural complications	—	—
Animal bite	Injury, poisoning and procedural complications	—	—
Arthropod bite	Injury, poisoning and procedural complications	—	—

Most-reported serious reactions: Hypersensitivity.

Data from ClinicalTrials.gov NCT01987817 adverse events section.

Sponsor's own description

This is a multi-center, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oral immunotherapy in peanut allergic individuals.

Publications & conference data

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

From Allergen Molecules to Molecular Immunotherapy of Nut Allergy: A Hard Nut to Crack.
Fuhrmann V, Huang HJ, Akarsu A, Shilovskiy I, et al · · 2021 · cited 21× · PMID 34630424 · DOI 10.3389/fimmu.2021.742732
IgE epitopes of Ara h 9, Jug r 3, and Pru p 3 in peanut-allergic individuals from Spain and the US.
Kronfel CM, Cheng H, McBride JK, Nesbit JB, et al · · 2022 · cited 6× · PMID 36698378 · DOI 10.3389/falgy.2022.1090114
IgE and IgG4 epitopes of the peanut allergens shift following oral immunotherapy.
Rambo IM, Kronfel CM, Rivers AR, Swientoniewski LT, et al · · 2023 · cited 5× · PMID 38093814 · DOI 10.3389/falgy.2023.1279290
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 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
NCT03337542 — AR101 Real-World Open-Label Extension Study · 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 NCT01987817 (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: 30 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/NCT01987817.

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