Study of Oral Food Challenge Biomarkers (SAFER)
ConditionAllergy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-17
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 currently avoiding peanut
Disqualifiers
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
Trial population
Approximately 500 participants with suspected peanut allergy, 12 months to 17 years of age
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Oral Food Challenge (OFC): Peanut Protein
DrugPeanut 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.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Oral Food Challenge Cohort1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
OFC Visit on Day 12
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.
Time frame
OFC Visit on Day 1Secondary outcomes
1
All reported treatments during the oral food challenge (OFC) or observational period.
Any treatments used to resolve dose-limiting symptoms in response to the OFC, including during and after the OFC, will be summarized descriptively for participants who had at least 1 dose of peanut protein during the OFC (including those that started but did not fully complete the OFC).
Time frame
OFC Visit on Day 12
All adverse events experienced during the OFC or observation period.
Any adverse events, defined as severe dose-limiting symptoms that are related to the OFC, that are experienced during and after the OFC will be summarized descriptively in participants who had at least 1 dose of peanut protein during the OFC (including those that started but did not fully complete the OFC).
Time frame
OFC Visit on Day 13
All symptoms reported during the OFC or observation period.
All OFC symptoms (i.e. including those that do not meet definition of an adverse event) experienced during the OFC or after the OFC will be summarized descriptively in participants who had at least 1 dose of peanut protein during the OFC (including those that started but did not fully complete the OFC).
Time frame
OFC Visit on Day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
Consortia for Food Allergy Research (CoFAR)
Collaborator
Rho Federal Systems Division, Inc.
Collaborator
Source ClinicalTrials.gov