Status:
COMPLETED
Peanut Oral Immunotherapy in Children
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Conditions:
Peanut Hypersensitivity
Eligibility:
All Genders
12-48 years
Phase:
PHASE2
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 chi...
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 in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 13 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2018
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT01867671
Start Date
August 13 2013
End Date
December 21 2018
Last Update
March 16 2020
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Arkansas for Medical Sciences: Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Stanford University School of Medicine
Stanford, California, United States, 94040
3
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
4
Mount Sinai School of Medicine
New York, New York, United States, 10029