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Food AllergyPhase 2CAFETERIANCT03907397

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

A Phase 2 study testing Peanut Protein and Continued peanut avoidance in people with Food Allergy and Peanut Allergy, run by Scott Sicherer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 4 to 14 years
Conditions the study is for
Food Allergy, Peanut Allergy
What is being tested?
Peanut Protein and Continued peanut avoidance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteUnited States
Study dates
5 Aug 2019to 17 Nov 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • -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.

Who cannot join

  • Individuals who meet any of these criteria are not eligible for enrollment as study participants:
  • 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).
Show all 29Show fewer
  • 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):
  • FEV1 value <80% predicted (only for participants age 7 years or older and are able to perform spirometry)
  • ACT or cACT < 20
  • >Step 3 controller therapy as defined for children 0-4, 5-11 and >=12 years of age by EPR-3 tables
  • Use of steroid medications in the following manners:
  • history of daily oral steroid dosing for >1 month during the past year,
  • having 1 burst or steroid course within the past 6 months, or
  • having >1 burst oral steroid course within the past 12 months.
  • Asthma requiring >1 hospitalization in the past year for asthma or >1 ED visit in the past 6 months for asthma, or any prior intubation/mechanical ventilation for asthma/wheezing.
  • When COVID related institutional restrictions on spirometry are in effect, spirometry will not be performed and peak flow will be used with 80% predicted as cut-off.
  • Gastrointestinal eosinophilic disorders, esophagitis, gastroenteritis.
  • Use of short-acting antihistamines (diphenhydramine, etc.) more than one time within 3 days prior to DBPCFC or skin testing.*
  • Use of medium-acting antihistamines (hydroxyzine, loratadine, etc.) more than one time within 7 days of DBPCFC or skin testing.*
  • Use of systemic steroid medications (IV, IM or oral) for indications other than asthma for > 3 weeks within the past 6 months
  • Use of beta-blockers (oral), (ACE) inhibitors, angiotensin-receptor blockers or calcium channel blockers.
  • Participation in any trials of therapeutic interventions for food allergy in the past year.
  • Therapy with anti-IgE or other biologics, including within 1 year of enrollment.
  • Use of investigational drugs within 52 weeks of participation.
  • Allergy to all of the following: oat, rice, corn, tapioca.
  • Pregnancy
  • Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
  • Any subject meeting these criteria during the visits can be rescheduled for the oral food challenge or prick skin testing.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: Challenging to Food With Escalating Thresholds for Reducing Food Allergy

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.

Being tested
Peanut Protein, Continued peanut avoidance
Keywords
allergy, food, peanut, threshold, immunotherapy
Medical subject headings
Food Hypersensitivity, Peanut Hypersensitivity, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peanut ProteinBiological

    up to 3 level teaspoons peanut butter or equivalent (approximately 3400 mg)

  • Continued peanut avoidanceOther

    Standard of care avoidance of peanut

Study groups in NCT03907397
Study groupRoleWhat they receive
TreatmentActive comparatorIngests peanut - . Depending upon reaction threshold, participants may begin with different starting amounts of store bought peanut butter measured with study-supplied kitchen measuring spoons.
Receives: Biological: Peanut Protein
AvoidanceOtherAvoids peanut, standard care
Receives: Other: Continued peanut avoidance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Children That Tolerate the Full Challenge

    The difference between the treatment and comparison (avoidance) groups in the percentage of children who by the endpoint double-blind, placebo-controlled oral food challenge (DBPCFC) tolerate a dose at least 2 steps higher than their baseline DBPCFC or 9043 mg of peanut protein.

    Due to missing data in the primary endpoint, the protocol \& SAP specified a priori that missing data would be imputed using multiple imputation and results based on 30 completed-imputed data sets would be combined using Rubin's rule. In the Peanut Protein group, the observed data was so strong that participants with missing data were also imputed as success across all imputations (hence, 100% success rate). In the Peanut Avoidance group, there was more variability in the proportion of successes across imputations and these varying proportions were averaged. Missing data were imputed and results were pooled.

    Measured: 72 weeks

Secondary outcomes (6)

  1. The Percentage of Children That Achieve Sustained Unresponsiveness

    The percentage of children who achieve sustained unresponsiveness or natural tolerance during the study.

    Measured: 96 weeks

  2. Number of Children With Acute Allergic Reactions

    Safety parameter assessed by number of participants with acute allergic reactions which includes anaphylaxis or gastrointestinal side effects.

    Measured: 96 weeks

  3. Mean Change in Food Allergy Quality of Life Parental Burden Instrument

    The Food Allergy Quality of Life-Parental Burden (FAQL-PB) Scale is a 17-item instrument. It utilizes a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). The number circled for each question is summed to provide a total continuous score range of 0 to 102 with a higher score indicating greater burden on the family.

    Measured: baseline and at 72 weeks

  4. Mean Change in SPT Wheal Size

    Change in Skin Prick Test (SPT) mean wheal size at 72 weeks as compared to baseline. A skin test reaction is considered positive if the wheal size for the antigen is at least 3 mm larger than the wheal size of the negative control (saline).

    Measured: Baseline and 72 weeks

  5. Mean Change in Peanut-specific IgE

    Mean Change in Peanut-specific IgE level at week 72 as compared to baseline.

    Measured: Baseline and 72 weeks

  6. Mean Change in Peanut-specific IgG4

    Mean Change in Peanut-specific IgG4 level at week 72 as compared to baseline.

    Measured: Baseline and 72 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2019
  2. Study start5 Aug 2019
  3. Primary completion17 Nov 2023
  4. Study completion17 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
150-200 children undergoing DBPCFC to peanut to identify 72 with high threshold peanut allergy for randomization in trial.
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03907397
Sponsor's protocol ID
GCO 17-0722
Other IDs
U19AI136053
Acronym
CAFETERIA
Status last verified
Feb 2025
First submitted
5 Apr 2019
Last updated
7 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Zhang L, Chun Y, Valeiron S, Grishina G, Lo T, Wang J, Sicherer S, Bunyavanich S. Coordinated changes in oral propionate, oral microbiota, and peripheral blood inflammatory processes during peanut oral immunotherapy. J Allergy Clin Immunol. 2026 Sep 2:S0091-6749(26)00624-X. doi: 10.1016/j.jaci.2026.08.015. Online ahead of print.

    PubMed 42685867

  • Sicherer SH, Bunyavanich S, Berin MC, Lo T, Groetch M, Schaible A, Perry SA, Wheatley LM, Fulkerson PC, Chang HL, Suarez-Farinas M, Sampson HA, Wang J. Peanut Oral Immunotherapy in Children with High-Threshold Peanut Allergy. NEJM Evid. 2025 Mar;4(3):EVIDoa2400306. doi: 10.1056/EVIDoa2400306. Epub 2025 Feb 10.

    PubMed 39928078

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Peanut Protein and Continued peanut avoidance in people with Food Allergy and Peanut Allergy, run by Scott Sicherer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Children That Tolerate the Full Challenge (time frame: 72 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03907397, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.

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