Peanut Oral Immunotherapy in Children
Trial ID or NCT#
NCT01867671
Status
NOT RECRUITING
Purpose
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.
Official Title
Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children (ITN050AD)
Eligibility Criteria
Ages Eligible for Study: 0 to 17
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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.
Investigator(s)
Michelle Huffaker, MD
Allergist,
Immunologist
Clinical Assistant Professor, Medicine - Pulmonary, Allergy & Critical Care Medicine
View on ClinicalTrials.gov
