NCT07279467

Study of Oral Food Challenge Biomarkers (SAFER)

Study of Oral Food Challenge Biomarkers (CoFAR-15)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 12 Months – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Allergy

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2025-12-12
• Last updated: 2025-12-12

Locations

10 sites across 1 country: United States