Mechanisms of Desensitization During Peanut Oral Immunotherapy
Condition: Food Hypersensitivity
MeSH terms: Hypersensitivity; Food Hypersensitivity
Intervention: Open label peanut OIT
Intervention description: Subject will take increasing amounts of peanut protein up to a maximum maintenace dose of 1450mg.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 4 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Peanut allergy

Summary:

      The purpose of this study is to attempt to understand how desensitization works in peanut
      allergic children who are undergoing oral immunotherapy (OIT) to peanut. We want to identify
      the early changes in the desensitization process the immune cells undergo to become
      desensitized to the peanut protein.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 4 to up to 12 years of age of any gender, race, or ethnicity.

          -  Minimum weight 16 kg at the time of enrollment.

          -  Physician diagnosis of peanut allergy OR convincing clinical history of an allergic
             reaction to peanut.

          -  Detectable serum peanut -specific IgE level (CAP-FEIA ≥ 0.35 kU/L) and a positive SPT
             (wheal ≥ 3mm on skin prick test to peanut extract compared to a negative control.)

          -  Allergic reaction to ≤ 1 gm peanut protein during a blinded oral challenge test
             conducted at screening (e.g., a double-blinded, placebo-controlled food challenge
             [DBPCFC]).

          -  Written informed consent from parent/guardian.

          -  Written assent from subject if applicable

          -  Consumption of oat-containing product within 90 days prior to enrollment

        Exclusion Criteria:

          -  History of allergic reaction to peanut consistent with severe anaphylaxis (defined as
             hypotension/shock; or neurologic impairment).

          -  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.

          -  Asthma defined as moderate or severe persistent by National Asthma Education and
             Prevention Program Expert Panel Guidelines (e.g. asthma 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 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.

          -  Inability to speak English.