Peanut Oral Immunotherapy in Children
Condition: Peanut Hypersensitivity
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Intervention: Peanut Oral Immunotherapy - Liquid Extract; Placebo for Peanut Oral Immunotherapy - Liquid Extract form; Peanut Oral Immunotherapy - Peanut Flour; Placebo for Peanut Oral Immunotherapy - Peanut Flour
Intervention description: Used during initial dose escalation for doses 0.1 to 0.8 mg.; Similar in appearance, texture, and taste to peanut liquid extract.; This will be used for the remainder of dose escalation, build-up, and maintenance.; Similar in appearance, texture, and taste to peanut flour.
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 146.0
Sex: All
Minimum age: 12 Months
Maximum age: 48 Months
Healthy volunteers: No
Keywords: Allergy, Peanut; Peanut allergy; Hypersensitivity; Immunotherapy; Desensitization, Immunologic

Summary:

      This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut
      oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in
      peanut-allergic children. Eligible participants with peanut allergy will be randomly assigned
      to receive either peanut OIT or placebo for 134 weeks followed by peanut avoidance for 26
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical history of peanut allergy or avoidance of peanut without ever having eaten
             peanut;

          -  Serum immunoglobulin E (IgE) to peanut of ≥5 kUA/L determined by UniCAP™, an in-vitro
             test system for diagnosis and monitoring of allergy and inflammation;

          -  Wheal ≥ 3mm on skin prick test to peanut extract compared to a negative control;

          -  A clinical reaction at or below ingestion of 1 g peanut flour (500 mg peanut protein)
             during screening OFC;

          -  Written informed consent from parent/guardian.

        Exclusion Criteria:

          -  History of severe anaphylaxis with hypotension to peanut;

          -  Documented clinical history of allergy to oat;

          -  Suspected allergy to oat and a wheal ≥7mm on skin prick test to oat extract compared
             to a negative control;

          -  Chronic disease other than asthma, atopic dermatitis, rhinitis requiring therapy;
             e.g., heart disease or diabetes;

          -  Active eosinophilic gastrointestinal disease in the past 2 years;

          -  Participation in any interventional study for the treatment of food allergy in the 6
             months prior to visit -1;

          -  Inhalant allergen immunotherapy that has not yet reached maintenance dosing;

          -  Severe asthma, as indicated by repeated hospitalizations or hospital emergency
             department visits;

          -  Moderate asthma defined according to National Asthma Education and Prevention Program
             Expert;

          -  Panel that requires more than fluticasone 440 mcg or its equivalent daily for adequate
             control;

          -  Inability to discontinue antihistamines for skin testing, OFC and the initial dose
             escalation;

          -  Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral
             or sublingual) in the 12 months prior to visit -1;

          -  Any systemic therapy which in the judgment of the investigator could be
             immunomodulatory (e.g. rituximab) in the 12 months prior to visit -1, systemic
             corticosteroid therapy of up to a total of three weeks is allowed;

          -  Use of any investigational drug in 90 days prior to visit -1;

          -  Plan to use any investigational drug during the study period;

          -  The presence of any medical condition that the investigator deems incompatible with
             participation in the trial.