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Immune Basis and Clinical Implications of Threshold-based Phenotypes of Peanut Allergy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Immune Basis and Clinical Implications of Threshold-based Phenotypes of Peanut Allergy

Challenging to Food With Escalating Thresholds for Reducing Food Allergy

NCT03907397•Scott Sicherer

View on ClinicalTrials.gov

Summary

The primary objective of this study is to determine whether allowing ingestion of sub-threshold amounts of peanut in those with a high threshold (tolerate at least 143 mg peanut protein on supervised double-blind, placebo-controlled oral food challenge \[DBPCFC\]) will be associated with attaining even higher thresholds over time in children with high threshold peanut allergy compared to those avoiding peanut. The secondary clinical objectives include assessing the development of sustained unresponsiveness (SU, a surrogate term for tolerance without daily ingestion), effects on quality of life, and safety compared to those avoiding peanut. Additionally, this study will phenotype the allergic response to peanut based on threshold and response to exposure. Mechanistic study objectives will determine the immune and molecular basis of the high threshold endotype, identify predictors of response to exposure, and determine mechanisms and biomarkers of remission.

Eligibility

Age

4 - 14 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject and/or parent guardian must be able to understand and provide informed consent.
•Age 4-14 years
•either sex
•any race, any ethnicity
•who are enrolled while strictly avoiding peanut
•have a history of sensitization (detectable peanut IgE \>0.35 kUA/L)
•On screening DBPCFC are able to ingest \>= 143 mg peanut protein but \< 5043 mg peanut protein.
•All children will have documented consent and assent as is appropriate for age.

Exclusion Criteria

•Inability or unwillingness of a participant to give written informed consent or comply with study protocol
•Serum peanut-specific IgE antibody level \> 50 kUA/L
•Recent (within the past 2 years) life-threatening (grade 3) anaphylactic reaction to peanut.
•Any disorder in which epinephrine is contraindicated such as known hypertension or cardia rhythm disorders.
•History of chronic disease requiring therapy (other than asthma, atopic dermatitis, rhinitis).
•On a build-up phase of any allergen immunotherapy.
•For those with a history of asthma, the following are assessed and any of the following is an exclusion (markers of current uncontrolled or moderate to severe asthma):
•1. FEV1 value \<80% predicted (only for participants age 7 years or older and are able to perform spirometry)
•2. ACT or cACT \< 20
•3. \>Step 3 controller therapy as defined for children 0-4, 5-11 and \>=12 years of age by EPR-3 tables
+18 more criteria

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Key Dates

Start Date

August 5, 2019

Primary Completion Date

November 17, 2023

Completion Date

November 17, 2023

Last Updated

February 7, 2025

Enrollment

ACTUAL participants

Conditions

Food AllergyPeanut Allergy

Interventions

Peanut Protein

BIOLOGICAL

Continued peanut avoidance

OTHER

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Immune Basis and Clinical Implications of Threshold-based Phenotypes of Peanut Allergy

Inclusion Criteria

Exclusion Criteria

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