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NCT02304991 · ClinicalTrials.gov registry record · Phase 2
FARE Peanut SLIT and Early Tolerance Induction
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT02304991 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 50 participants.
The verdict
NCT02304991, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
Primary Objective: To determine if 36 months of peanut SLIT as an early intervention in subjects ages 1 to 4 years induces clinical desensitization. The primary outcome of this objective will be a statistically significant difference in challenge scores between the treatment group versus the placebo group during DBPCFC (Double blind placebo controlled food challenge) performed after 36 months of peanut SLIT (desensitization). Challenge scores are measured by the amount of peanut protein participants are able to ingest successfully without symptoms of an allergic reaction. \[Time Frame: Baseline, 36 months\] Secondary Objectives: A secondary outcome of this objective will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance). To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. \[Time Frame: Baseline, 39 months\]
Interventions
- DRUG Liquid Peanut Extract
- DRUG Placebo Glycerin SLIT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2015-01 |
| Est. Completion | 2020-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02304991
The ClinicalTrials.gov registry entry for NCT02304991 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Liquid Peanut Extract is the first listed.
NCT02304991 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02304991 about?
NCT02304991 is a clinical study titled "FARE Peanut SLIT and Early Tolerance Induction". Primary Objective: To determine if 36 months of peanut SLIT as an early intervention in subjects ages 1 to 4 years induces clinical desensitization. The primary outcome of this objective will be a statistically significant difference in challenge scores between the treatment group versus the placebo...
What is the current status of trial NCT02304991?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2015-01. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT02304991?
The interventions under investigation include: Liquid Peanut Extract (DRUG), Placebo Glycerin SLIT (DRUG).
Who is sponsoring clinical trial NCT02304991?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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