CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Peanut OITdrug
Likely dose
Peanut OIT 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03251508
NCT03251508Phase 2Completed

Salvage Peanut Oral Immunotherapy Study: A Single-arm, Open Label Trial of Peanut Flour With 6 Month Active Treatment and 6 Month Follow-up

University of North Carolina, Chapel Hill·interventional·Posted Aug 16, 2017·Updated Jan 30, 2023

In Brief

A Phase 2 clinical trial evaluating Peanut OIT for Peanut Allergy. Completed, enrolled 15 participants across 1 site.

Detailed Summary

The purpose of this trial is to study the safety of rescue peanut oral immunotherapy followed by the introduction of dietary peanut for patients with peanut allergy who have lost desensitization during a peanut immunotherapy trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeanut Allergy
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 16, 2017
Enrollment StartJan 3, 2018
Primary CompletionNov 23, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.9 years ago

Interventions

Peanut OITdrug

Participants will be given increasing doses of the peanut flour as peanut oral immunotherapy (OIT) with increasing doses every 2 weeks over a period of 3 months up to a 300 mg target dose. This 300 mg peanut OIT maintenance dose is then continued daily for 3 months. Participants will then introduce dietary peanut of approximately 300 mg of peanut protein and continue daily ingestion for an additional 6 months.