Peanut Oral Immunotherapy Study of Early Intervention for Desensitization
POSEIDON
1 other identifier
interventional
146
4 countries
23
Brief Summary
The purpose of this study is to determine the efficacy and safety of AR101 in peanut-allergic children aged 1 to \< 4 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2018
Typical duration for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2018
CompletedFirst Posted
Study publicly available on registry
November 9, 2018
CompletedStudy Start
First participant enrolled
December 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2022
CompletedResults Posted
Study results publicly available
March 2, 2023
CompletedMarch 2, 2023
February 1, 2023
3.5 years
November 7, 2018
February 2, 2023
February 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)
The percentage of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild allergy symptoms during the exit double-blind placebo-controlled food challenge (DBPCFC).
12 months
Secondary Outcomes (3)
Percentage of Subjects Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) [Time Frame: 12 Months]
12 months
Percentage of Subjects Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)
12 months
Maximum Severity of Symptoms in Participants at Any Challenge Dose During the Exit Double-blind Placebo Controlled Food Challenge (DBPCFC)
12 months
Study Arms (2)
AR101 powder provided in capsules & sachets
ACTIVE COMPARATORStudy product provided as peanut protein in pull-apart capsules or sachets
Placebo powder provided in capsules & sachets
PLACEBO COMPARATORPlacebo formulation in pull-apart capsules or sachets containing only inactive ingredients
Interventions
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
Study product formulated to contain only inactive ingredients for use as defined in the protocol
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Sean N. Parker Center for Allergy & Asthma Reseach, LPCH at El Camino Hospital
Mountain View, California, 94040, United States
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, 90274, United States
Allergy & Asthma Medical Group and Research Center
San Diego, California, 92123, United States
Children's Center for Advanced Pediatrics Clinical Research Lab
Atlanta, Georgia, 30329, United States
Atlanta Allergy & Asthma Clinic
Marietta, Georgia, 30060, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
The John Hopkins Hospital
Baltimore, Maryland, 21287, United States
University of Michigan Division of Allergy and Clinical Immunology
Ann Arbor, Michigan, 48106, United States
Atlantic Research Center
Ocean City, New Jersey, 07712, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
UNC-CH School of Medicine, Pediatric Allergy, Immunology & Rheumatology, Food Allergy
Chapel Hill, North Carolina, 27599, United States
Clinical Research of Charlotte
Charlotte, North Carolina, 28277, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Jeanne de Flandre Hospital
Lille, France
Charité Universitaetsmedizin Berlin
Berlin, 13353, Germany
University of Frankfurt
Frankfurt am Main, 60590, Germany
James Paget University Hospital
Gorleston-on-Sea, Norfolk, NR31 6LA, United Kingdom
Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
Guy's and St. Thomas' NHS Foundation Trust, Snowy Owl, First Floor, Evelina Children's Hospital
London, SEI 7EH, United Kingdom
Royal Manchester Children's Hospital Central Manchester University Hospitals
Manchester, M13 9WL, United Kingdom
Sheffield Children's Hospital
Sheffield, S10 2TH, United Kingdom
University Hospital Southampton Foundation NHS Trust Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (1)
Du Toit G, Brown KR, Vereda A, Irani AM, Tilles S, Ratnayake A, Jones SM, Vickery BP. Oral Immunotherapy for Peanut Allergy in Children 1 to Less Than 4 Years of Age. NEJM Evid. 2023 Nov;2(11):EVIDoa2300145. doi: 10.1056/EVIDoa2300145. Epub 2023 Oct 23.
PMID: 38320526DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Regulatory Affairs
- Organization
- Aimmune Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
Director of Regulatory Affairs
Aimmune Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double-Blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2018
First Posted
November 9, 2018
Study Start
December 27, 2018
Primary Completion
July 5, 2022
Study Completion
July 5, 2022
Last Updated
March 2, 2023
Results First Posted
March 2, 2023
Record last verified: 2023-02