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NCT03907397 · ClinicalTrials.gov registry record · Phase 2
Immune Basis and Clinical Implications of Threshold-based Phenotypes of Peanut Allergy
A Phase 2 study of Food Allergy and Peanut Allergy, sponsored by Scott Sicherer.
- Completed
- Registry status
- Phase 2
- Development phase
- 73
- Enrollment target
- 1
- Study location
NCT03907397: Completed Phase 2 study of Food Allergy and Peanut Allergy, sponsored by Scott Sicherer.
NCT03907397 is a Phase 2 study of Food Allergy and Peanut Allergy that has completed, run by Scott Sicherer. The registered enrollment target is 73 participants, below the 960-participant average among 17 other Food Allergy trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03907397, a Phase 2 study of Food Allergy and Peanut Allergy, has completed, sponsored by Scott Sicherer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 73 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Primary Outcome
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 usin
Conditions Studied
Interventions
- BIOLOGICAL Peanut Protein
- OTHER Continued peanut avoidance
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2019-08-05 |
| Est. Completion | 2023-11-17 |
| Phase | Phase 2 |
What the finished NCT03907397 record still lists
NCT03907397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 960-participant average among 17 other Food Allergy trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Food Allergy appearing as the primary indexed condition, and to 2 interventions - of which Peanut Protein is the first listed.
NCT03907397 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03907397 about?
NCT03907397 is a clinical study titled "Immune Basis and Clinical Implications of Threshold-based Phenotypes of Peanut 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 e...
What is the current status of trial NCT03907397?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 73 participants. The study started on 2019-08-05. Estimated completion is 2023-11-17.
What conditions does trial NCT03907397 study?
This clinical trial studies the following conditions: Food Allergy, Peanut Allergy.
What interventions are being tested in trial NCT03907397?
The interventions under investigation include: Peanut Protein (BIOLOGICAL), Continued peanut avoidance (OTHER).
Who is sponsoring clinical trial NCT03907397?
This trial is sponsored by Scott Sicherer, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03907397 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03907397's enrollment target sits among peer trials
73 8th of 17 higher than 9 of 17 other Food Allergy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Food Allergy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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