Study of Oral Food Challenge Biomarkers (SAFER)

NCT07279467 | Not Yet Recruiting DMC

• 1 other identifier: DAIT CoFAR-15
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 10

Brief Summary

This is a multi-center, mechanistic study. It is designed to learn more about signs in the body, called biomarkers, that might show if someone will have a reaction to peanut during a feeding test. The trial will enroll children ages 12 months to17 years old who are suspected of having an allergy to peanut. The primary objective is to identify a biomarker (or a combination of biomarkers) that will predict oral food challenge (OFC) (feeding test) results for participants with suspected peanut allergy.

Conditions

Allergy

Keywords

Food Allergy; Peanut Allergy; Oral Food Challenge; CoFAR-15; SAFER; Biomarkers

Outcome Measures

Primary Outcomes (2)

• Cumulative Reactive Dose (CRD) Threshold

  The cumulative quantity of peanut protein consumed during an oral food challenge at which dose-limiting symptoms occur, categorized as: 3-143 mg (low threshold); 443-1043 mg (medium threshold); 2043-highest cumulative, age-dependent dose (high threshold); or no reaction. The maximum cumulative dose of peanut protein for completion of the oral food challenge (OFC) is 4043 mg for participants aged 1 to 3 years and 6043 mg for participants aged 4 to 17 years. Participants ≤3 years are not required to receive the final 2000mg dose to complete the OFC, however, it may be administered at the discretion of the investigator if considered clinically relevant and safe.

  OFC Visit on Day 1

• Binary Reaction Status (reactor/non-reactor) to the oral food challenge (OFC)

  A Reactor is any participant who experiences dose-limiting symptoms at or prior to the highest cumulative, age-dependent OFC dose. A Non-reactor is any participant who does not experience dose-limiting symptoms during an OFC that is completed to the age-specific highest dose.

  OFC Visit on Day 1

Secondary Outcomes (3)

• All reported treatments during the oral food challenge (OFC) or observational period.

  OFC Visit on Day 1

• All adverse events experienced during the OFC or observation period.

  OFC Visit on Day 1

• All symptoms reported during the OFC or observation period.

  OFC Visit on Day 1

Study Arms (1)

Oral Food Challenge Cohort

Approximately 500 children and adolescent participants between the ages of 1-17 years who are suspected of having an allergy to peanut will be asked to complete a Peanut Oral Food Challenge. An individual's participation in this study will consist of screening for eligibility and an oral food challenge visit, which may occur on the same day or up to 28 days apart.

Drug: Oral Food Challenge (OFC): Peanut Protein

Interventions

Oral Food Challenge (OFC): Peanut Protein DRUG

Peanut protein flour will be used in the OFC procedure. The maximum cumulative dose of peanut protein for completion of the oral food challenge (OFC) is 6043 mg. Participants aged 3 years or younger are not required to receive the final 2000 mg dose to complete the OFC; however, it may be administered at the discretion of the investigator if considered clinically relevant and safe.

Also known as: OFC

Oral Food Challenge Cohort

Eligibility Criteria

• Age: 12 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 500 participants with suspected peanut allergy, 12 months to 17 years of age

You may qualify if:

• Parent or guardian must be able to understand and provide written informed consent and participant must be able to understand and provide assent (if applicable)
• Are 12 months - 17 years of age during Screening.
• Are sensitized to peanut, as demonstrated by one of the following:
• a. A participant-reported reaction to peanut (at any time) deemed by the investigator to be consistent with an IgE-mediated reaction and one of the following within the past 12 months
• i. Positive Skin Prick Test (SPT) to peanut (wheal diameter that is ≥ 3mm larger than saline control) ii. Positive peanut-specific IgE (sIgE; ≥ 0.10 kUA/L) determined by ImmunoCap
• b. An Ara h 2 sIgE ≥ 1.0 kUA/L, measured within the past 12 months
• Are currently avoiding peanut

You may not qualify if:

• Are pregnant
• Are currently receiving treatment or have received treatment within the prior 2 years for peanut allergy
• Have a history of life-threatening anaphylaxis to peanut, defined as neurological compromise or requiring intubation
• Have received treatment with dupilumab/Dupixent® within the prior 2 years, OR treatment with omalizumab/Xolair®, other biologics, or systemic immunomodulatory agents within the prior year
• Inability to comply with the required aspects of the study protocol
• Have past or current medical conditions or findings from the physical examination, not already listed, that, in the judgment of the site investigator, may pose additional risks related to participation in the study, interfere with the participant's ability to comply with study requirements, or impact the quality or interpretation of the study data
• Have been treated with oral steroid or beta blockers within 14 days of the Oral Food Challenge (OFC)
• Are unable to discontinue medications, as specified in the Protocol CoFAR-15 MOP, for the minimum wash-out periods prior to Skin Prick Test (SPT) or OFC
• Have poorly controlled atopic dermatitis (AD) at Screening, per the PI's discretion
• Have poorly controlled or severe asthma/wheezing at Screening, as defined as experiencing or including any of the following:
• Meeting the Global Initiative for Asthma (GINA) criteria for uncontrolled asthma
• History of two or more systemic corticosteroid courses within six months of Screening or one course of systemic corticosteroids within three months of Screening to treat asthma/wheezing;
• Prior intubation/mechanical ventilation for asthma/wheezing;
• One hospitalization or ED visit for asthma/wheezing within six months of Screening;
• Forced expiratory volume in one second (FEV1) \<80% of predicted or FEV1/forced vital capacity (FVC) \<75% of predicted, with or without controller medications (only for participants who are aged seven years or older and are able to perform spirometry);

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Consortia for Food Allergy Research (CoFAR): collaborator
• Rho Federal Systems Division, Inc.: collaborator

Study Sites (10)

Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology

Little Rock, Arkansas, 72202, United States

Location

Stanford School of Medicine: Sean N. Parker Center for Allergy & Asthma Research

Palo Alto, California, 94304, United States

Location

Northwestern University Feinberg School of Medicine: Allergy Division

Chicago, Illinois, 60611-2927, United States

Location

Johns Hopkins Children's Center: Department of Allergy & Immunology

Baltimore, Maryland, 21287-0010, United States

Location

Boston Children's Hospital: Allergy and Asthma Program

Boston, Massachusetts, 02115, United States

Location

The University of Michigan: Division of Allergy and Clinical Immunology

Detroit, Michigan, 48201, United States

Location

Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology

New York, New York, 10029, United States

Location

North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology

Chapel Hill, North Carolina, 27599, United States

Location

Cincinnati Children's Hospital Medical Center: Division of Allergy and Immunology

Cincinnati, Ohio, 45229, United States

Location

Vanderbilt University Medical Center: Division of Pediatric Allergy, Immunology, and Pulmonary Medicine

Nashville, Tennessee, 37232, United States

Location

Related Links

• Division of Allergy, Immunology, and Transplantation (DAIT)
• National Institute of Allergy and Infectious Diseases (NIAID)

MeSH Terms

Conditions

Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity

Study Officials

• Robert Wood, M.D.

  Johns Hopkins Children's Center: Department of Allergy & Immunology

  STUDY CHAIR

• Supinda Bunyavanich, M.D., M.P.H., M.Phil.

  Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology

  STUDY CHAIR

• Charles Schuler, M.D.

  The University of Michigan: Division of Allergy and Clinical Immunology

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: December 12, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: On average, within 24 months after database lock for the trial.
• Access Criteria: Open access.

Locations

US (10)