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

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• Hypersensitivity 1,916
• Food Hypersensitivity 340
• Peanut Hypersensitivity 152

Keywords

• allergy
• food
• peanut
• threshold
• immunotherapy

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 73 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.

Lead sponsor

This is the only study on the registry with Scott Sicherer as lead sponsor.

Eligibility criteria

Study arms

• Active comparator
  Treatment

  Ingests peanut - . Depending upon reaction threshold, participants may begin with different starting amounts of store bought peanut butter measured with study-supplied kitchen measuring spoons.

  Biological: Peanut Protein

• Other
  Avoidance

  Avoids peanut, standard care

  Other: Continued peanut avoidance

Interventions

• BiologicalPeanut Protein

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

• OtherContinued peanut avoidance

  Standard of care avoidance of peanut

Primary outcomes

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.

   Time frame: 72 weeks

Secondary outcomes

1. The Percentage of Children That Achieve Sustained Unresponsiveness

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

   Time frame: 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.

   Time frame: 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.

   Time frame: 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).

   Time frame: 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.

   Time frame: 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.

   Time frame: Baseline and 72 weeks

Baseline characteristics

1 further baseline measures are reported on the registry.

Study documents

• Study protocol · Nov 9, 2021
• Statistical analysis plan · Jan 23, 2024
• Informed consent form · Feb 28, 2023

Documents are hosted by the registry — open the source record to download them.