Overview

This trial is active, not recruiting.

Condition peanut hypersensitivity
Treatments 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
Phase phase 2
Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator Immune Tolerance Network (ITN)
Start date August 2013
End date September 2018
Trial size 146 participants
Trial identifier NCT01867671, DAIT ITN050AD

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Peanut OIT for 134 weeks followed by peanut avoidance for 26 weeks.
peanut oral immunotherapy - liquid extract
Used during initial dose escalation for doses 0.1 to 0.8 mg.
peanut oral immunotherapy - peanut flour
This will be used for the remainder of dose escalation, build-up, and maintenance.
(Placebo Comparator)
Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks. The placebo extract will be derived from oat flour source material.
placebo for peanut oral immunotherapy - liquid extract form
Similar in appearance, texture, and taste to peanut liquid extract.
placebo for peanut oral immunotherapy - peanut flour
Similar in appearance, texture, and taste to peanut flour.

Primary Outcomes

Measure
Proportion of Desensitized Subjects
time frame: week 134

Secondary Outcomes

Measure
Tolerance Endpoint
time frame: week 160
Transient Desensitization
time frame: week 134 to week 160
Highest Tolerated Cumulative Dose
time frame: week 160
The incidence of all adverse events
time frame: week 160
Rates of Withdrawal from OIT or Placebo
time frame: week 160

Eligibility Criteria

Male or female participants from 12 months up to 48 months old.

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.

Additional Information

Official title Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children (ITN050AD)
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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID).