Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children (IMPACT)

Brief 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.Detailed Description:An initial oral food challenge (OFC) to 1 g of peanut flour (500 mg peanut protein) will be conducted. Participants must have a clinical reaction during this OFC to initiate study dosing. After the initial OFC, the study design includes four phases:Initial dose escalation (1 day): Peanut or placebo dosing will be given incrementally and increase every 20 minutes until a dose of 12 mg peanut flour (6 mg peanut protein) or placebo flour is given. Build-up (30 weeks): Initial observed dose administration of highest tolerated dose, followed by daily OIT at home with return visit every 2 weeks for dose escalation. Maintenance (104 weeks):The participant will continue on daily OIT with return visits every 13 weeks. At the end of this phase the participant will undergo a blinded OFC to 10 g peanut flour (5 g peanut protein). Avoidance (26 weeks): In this final phase participants will be seen every 13 weeks. At the completion of this phase participants will have a final blinded OFC to 10g peanut flour (5 g peanut protein)]]>
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.]]>