Study of Oral Food Challenge Biomarkers (SAFER)

Официальное название

Study of Oral Food Challenge Biomarkers (CoFAR-15)

Обзор

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.

Подробное описание

The SAFER study is a multi-center, mechanistic study designed to identify biomarkers that can predict the outcome of a participant's reactions to a peanut oral food challenge. Participants aged 12 months to 17 years with suspected peanut allergy will complete an oral food challenge to peanut. The accrual goal of the study is to reach a minimum of 500 participants who complete the oral food challenge and provide blood needed to assess biomarkers. Recruitment may continue beyond 500 to ensure there are at least 350 reactors (i.e., participants who experience dose-limiting symptoms during the OFC) and 100 non-reactors. Recruitment will aim to achieve approximate balance across three age groups: 12-47 months, 4-11 years, and 12-17 years.

An initial screening visit will be conducted to evaluate eligibility and collect the biomarkers prior to the oral food challenge. The food challenge can take place on the same day as screening or within 4 weeks of the screening visit.

During participation, clinical assessments will be conducted, questionnaires completed, and biological samples collected from the participant before, during, and after the challenge.

After the food challenge and the safety monitoring period is completed, the participant will have completed participation in the study.

Вмешательства

• Препарат Oral Food Challenge (OFC): Peanut Protein
  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.

Первичные конечные точки

• Cumulative Reactive Dose (CRD) Threshold [Срок оценки: OFC Visit on Day 1]
• Binary Reaction Status (reactor/non-reactor) to the oral food challenge (OFC) [Срок оценки: OFC Visit on Day 1]

Вторичные конечные точки (3)

• All reported treatments during the oral food challenge (OFC) or observational period. [Срок оценки: OFC Visit on Day 1]
• All adverse events experienced during the OFC or observation period. [Срок оценки: OFC Visit on Day 1]
• All symptoms reported during the OFC or observation period. [Срок оценки: OFC Visit on Day 1]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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);
• Inhaled corticosteroid (ICS) dosing of >500 mcg daily fluticasone (or equivalent ICS based on the CoFAR Inhaled Corticosteroid Equivalency Tables MOP)
• Refuse blood sample collection during Screening
• The SPT performed during Screening is negative to peanut allergen without dilution (wheal diameter that is < 3mm larger than saline control).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Центры проведения

США · 10 центров

• Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immun — Little Rock
• Stanford School of Medicine: Sean N. Parker Center for Allergy & Asthma Research — Palo Alto
• Northwestern University Feinberg School of Medicine: Allergy Division — Chicago
• Johns Hopkins Children's Center: Department of Allergy & Immunology — Baltimore
• Boston Children's Hospital: Allergy and Asthma Program — Boston
• The University of Michigan: Division of Allergy and Clinical Immunology — Detroit
• Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology — New York
• North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunol — Chapel Hill
• … и ещё 2 центра

Идентификаторы

NCT: NCT07279467 · DAIT CoFAR-15

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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