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Trial record 1 of 1 for:    Peanut Oral Immunotherapy Study of Early Intervention for Desensitization
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Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON)

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ClinicalTrials.gov Identifier: NCT03736447
Recruitment Status : Completed
First Posted : November 9, 2018
Last Update Posted : July 25, 2022
Sponsor:
Information provided by (Responsible Party):
Aimmune Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE November 7, 2018
First Posted Date  ICMJE November 9, 2018
Last Update Posted Date July 25, 2022
Actual Study Start Date  ICMJE December 27, 2018
Actual Primary Completion Date July 5, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2019)
Efficacy of AR101 [ Time Frame: 12 months ]
The proportion of subjects treated with AR101 compared with placebo who tolerate an at least 600 mg single dose (for patients in the US) or 1000 mg single dose (for patients in Europe) of peanut protein with no more than mild allergy symptoms during the exit double-blind placebo-controlled food challenge (DBPCFC).
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2018)
Efficacy of AR101 [ Time Frame: 12 months ]
The proportion of subjects treated with AR101 compared with placebo who tolerate an at least 600 mg single dose of peanut protein with no more than mild allergy symptoms during the exit double-blind placebo-controlled food challenge (DBPCFC).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peanut Oral Immunotherapy Study of Early Intervention for Desensitization
Official Title  ICMJE Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON)
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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
2:1 randomization
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Double-Blinded
Primary Purpose: Treatment
Condition  ICMJE Peanut Allergy
Intervention  ICMJE
  • Biological: AR101 powder
    AR101 powder provided in capsules and sachets (peanut allergen formulation)
  • Biological: Placebo powder
    Placebo powder provided in capsules and sachets
Study Arms  ICMJE
  • 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.
    Intervention: Biological: AR101 powder
  • 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.
    Intervention: Biological: Placebo powder
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2021)
146
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2018)
105
Actual Study Completion Date  ICMJE July 5, 2022
Actual Primary Completion Date July 5, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 3 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03736447
Other Study ID Numbers  ICMJE ARC005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Aimmune Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Aimmune Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Freddy Byrth Aimmune Therapeutics
PRS Account Aimmune Therapeutics, Inc.
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP