FARE - Food Allergy Research & Education Logo

Peanut Oral Immunotherapy Study of Early Intervention for Desensitization

Study Purpose

The purpose of this study is to determine the efficacy and safety of AR101 in peanut‑allergic children aged 1 to < 4 years.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 1 Year - 3 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Aged 1 to < 4 years at randomization.
  • - Written informed consent from the legal guardian/parent (or both parents where required by local authorities).
Provide assent where required and as appropriate per local requirements.
  • - Sensitivity to peanut, defined as one of the following: No known history of peanut ingestion and has serum IgE to peanut ≥ 5 kUA/L within 12 months before randomization.
Documented history of physician-diagnosed IgE-mediated peanut allergy that includes the onset of characteristic* signs and symptoms of allergy within 2 hours of known oral exposure to peanut or peanut-containing food, and has a mean wheal diameter on skin prick test (SPT) to peanut of at least 3 mm greater than the negative control (diluent) or serum IgE to peanut ≥ 0.35 kUA/L, obtained within 12 months before randomization.
  • - Development of age-appropriate dose-limiting allergy symptoms after consuming single doses of peanut protein > 3 mg to ≤ 300 mg in a screening DBPCFC.
  • - A palatable vehicle food to which the subject is not allergic must be available for administering study product.

Exclusion Criteria:

  • - History of severe or life‑threatening anaphylaxis anytime before the screening DBPCFC.
  • - History of hemodynamically significant cardiovascular or renovascular disease, including uncontrolled or inadequately controlled hypertension.
  • - History of biopsy-confirmed diagnosis of EoE; other eosinophilic GI disease; chronic, recurrent, or severe gastroesophageal reflux disease (GERD); or symptoms of dysphagia (eg, difficulty swallowing, food "getting stuck").
  • - Recurrent GI symptoms considered clinically significant in the opinion of the investigator.
  • - History of a mast cell disorder including mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (eg, cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema.
  • - Moderate or severe persistent asthma (criteria steps 3-6; National Heart, Lung, and Blood Institute [NHLBI], 2007).
  • - Mild asthma (criteria steps 1-2; NHLBI, 2007) that is uncontrolled or difficult to control based on NHLBI 2007 criteria.
  • - History of high-dose corticosteroid use (eg, 1-2 mg/kg prednisone or equivalent for > 3 days) by any route of administration as defined by any of the following: - Steroid administered daily for > 1 month within 1 year before screening - One steroid course within 6 months before screening - More than 2 steroid courses ≥ 1 week in duration within 1 year before screening - History of food protein-induced enterocolitis syndrome (FPIES) within 12 months before screening.
  • - Recurrent urticaria.
  • - History of failure to thrive or any other form of abnormal growth, or developmental or speech delay that precludes age-appropriate communication.
  • - History of chronic disease (except mild intermittent asthma, mild persistent asthma that is controlled, atopic dermatitis, or allergic rhinitis) that is or is at significant risk of becoming unstable or requiring a change in a chronic therapeutic regimen.
  • - Unable to discontinue antihistamines and other medications that could interfere with the assessment of an allergic reaction for 5 half-lives of the medication before the screening SPT, first day of dose escalation, and DBPCFCs.
  • - Use or anticipated use of a prohibited medication (eg, beta blockers [oral], angiotensin converting enzyme inhibitors, angiotensin receptor blockers, calcium channel blockers, or tricyclic antidepressants), monoclonal antibody, or any other immunomodulatory therapy (including immunosuppressive medications).
  • - Treatment with any form of immunotherapy for any food allergy anytime before screening.
  • - Participation in another clinical trial within 30 days or 5 half-lives of the investigational product, whichever is longer, before screening.
  • - Allergy to oat or rice.
  • - Hypersensitivity to epinephrine or any of the excipients in the epinephrine auto-injector.
  • - Parent/caregiver unable or unwilling to use epinephrine auto-injectors.
  • - Unable to follow the protocol requirements.
  • - Any other condition (concurrent disease, infection, comorbidity, or psychiatric or psychological disorders) or reason that may interfere with the ability to participate in the study, cause undue risk, or complicate the interpretation of data, in the opinion of the investigator or medical monitor.
  • - Resides at the same place as another subject in any AR101 interventional trial.
  • - Lives in the same household and/or is a family member of a sponsor employee or site staff involved in conducting this study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Aimmune Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Freddy Byrth
Principal Investigator Affiliation Aimmune Therapeutics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Active, not recruiting
Countries France, Germany, United Kingdom, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Peanut Allergy
Study Website: View Trial Website
Additional Details

To determine the efficacy and safety of AR101 in a characterized oral desensitization immunotherapy (CODIT™) regimen compared with placebo in peanut‑allergic children aged 1 to < 4 years.

Arms & Interventions


Active Comparator: AR101 powder (Peanut allergen formulation)

Subjects will be randomized to active arm of ARC005 and will be administered IP (AR101) in escalating doses for approximately 6 months.

Placebo Comparator: Placebo powder

Subjects will be randomized to placebo arm of ARC005 and will be administered escalating doses of IP (placebo) for approximately 6 months.


Biological: - AR101 powder

AR101 powder provided in capsules and sachets (peanut allergen formulation)

Biological: - Placebo powder

Placebo powder provided in capsules and sachets

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arkansas Children's Hospital, Little Rock, Arkansas



Arkansas Children's Hospital

Little Rock, Arkansas, 72202

Mountain View, California



Sean N. Parker Center for Allergy & Asthma Reseach, LPCH at El Camino Hospital

Mountain View, California, 94040

Peninsula Research Associates, Inc., Rolling Hills Estates, California



Peninsula Research Associates, Inc.

Rolling Hills Estates, California, 90274

San Diego, California



Allergy & Asthma Medical Group and Research Center

San Diego, California, 92123

Atlanta, Georgia



Children's Center for Advanced Pediatrics Clinical Research Lab

Atlanta, Georgia, 30329

Atlanta Allergy & Asthma Clinic, Marietta, Georgia



Atlanta Allergy & Asthma Clinic

Marietta, Georgia, 30060

Chicago, Illinois



Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611

The John Hopkins Hospital, Baltimore, Maryland



The John Hopkins Hospital

Baltimore, Maryland, 21287

Ann Arbor, Michigan



University of Michigan Division of Allergy and Clinical Immunology

Ann Arbor, Michigan, 48106

Atlantic Research Center, Ocean City, New Jersey



Atlantic Research Center

Ocean City, New Jersey, 07712

Icahn School of Medicine at Mount Sinai, New York, New York



Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Chapel Hill, North Carolina



UNC-CH School of Medicine, Pediatric Allergy, Immunology & Rheumatology, Food Allergy

Chapel Hill, North Carolina, 27599

Clinical Research of Charlotte, Charlotte, North Carolina



Clinical Research of Charlotte

Charlotte, North Carolina, 28277

Virginia Mason Medical Center, Seattle, Washington



Virginia Mason Medical Center

Seattle, Washington, 98101

International Sites

Jeanne de Flandre Hospital, Lille, France



Jeanne de Flandre Hospital

Lille, ,

Charité Universitaetsmedizin Berlin, Berlin, Germany



Charité Universitaetsmedizin Berlin

Berlin, , 13353

University of Frankfurt, Frankfurt am Main, Germany



University of Frankfurt

Frankfurt am Main, , 60590

James Paget University Hospital, Gorleston-on-Sea, Norfolk, United Kingdom



James Paget University Hospital

Gorleston-on-Sea, Norfolk, NR31 6LA

Leicester Royal Infirmary, Leicester, United Kingdom



Leicester Royal Infirmary

Leicester, , LE1 5WW

London, United Kingdom



Snowy Owl, First Floor, Evelina Childrens Hospital

London, , SEI 7EH

Manchester, United Kingdom



Royal Manchester Children's Hospital Central Manchester University Hospitals

Manchester, , M13 9WL

Sheffield Children's Hospital, Sheffield, United Kingdom



Sheffield Children's Hospital

Sheffield, , S10 2TH

Southampton, United Kingdom



University Hospital Southampton Foundation NHS Trust Southampton General Hospital

Southampton, , SO16 6YD

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.