NCT03251508: SOIT

Salvage Peanut Oral Immunotherapy Study

Completed Phase 1, PHASE2 Results posted Last updated 30 January 2023

What this trial tests

Phase 1, PHASE2 trial testing Peanut OIT in Peanut Allergy in 15 participants. Completed in 23 November 2021.

Timeline

3 January 2018

Primary endpoint
23 November 2021

23 November 2021

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	3 January 2018
Primary completion	23 November 2021
Estimated completion	23 November 2021
Sites	1 location across United States

Drugs / interventions tested

• Peanut OIT — full drug profile →

Conditions studied

• Peanut Allergy — all drugs for Peanut Allergy →

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 1 to 65, any sex, with Peanut Allergy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Experiencing Treatment-emergent Adverse Events During the 2-stage Study Sequence (Safety) Primary · 12 months

Percentage of participants experiencing an adverse event related to peanut oral immunotherapy (OIT) or dietary peanut ingestion

Group	Value	95% CI
Open-label Peanut Oral Immunotherapy/Dietary Peanut	60

Percentage of Missed Doses During the 2-stage Study Sequence (Compliance) Secondary · 12 months

Evaluation of patient compliance with a 2-stage peanut oral immunotherapy (OIT) and dietary peanut protocol as measured by the percentage of doses missed over the entire 2-stage study protocol sequence.

Group	Value	95% CI
Open-label Peanut Oral Immunotherapy/Dietary Peanut	1.2

Percentage of Participants Experiencing Treatment-emergent Adverse Events During the Peanut Oral Immunotherapy Stage Secondary · 6 months

Evaluation of peanut oral immunotherapy (OIT) safety measured by the percentage of participants experiencing an adverse event related to peanut OIT during the peanut oral immunotherapy (OIT) stage of the 2-stage Peanut Oral Immunotherapy/Dietary Peanut protocol.

Group	Value	95% CI
Open-label Peanut Oral Immunotherapy/Dietary Peanut	60

Percentage of Missed Doses During the Peanut Oral Immunotherapy Stage Secondary · 6 months

Evaluation of patient compliance measured by the percentage of doses missed during the peanut oral immunotherapy (OIT) stage of the 2-stage Peanut Oral Immunotherapy/Dietary Peanut protocol.

Group	Value	95% CI
Open-label Peanut Oral Immunotherapy/Dietary Peanut	2.1

Percentage of Participants Utilizing Emergency Epinephrine Use During the 2-Stage Study Sequence (Safety) Secondary · 12 months

Percentage of participants utilizing epinephrine for treatment of an adverse event related to peanut oral immunotherapy (OIT) or dietary peanut

Group	Value	95% CI
Open-label Peanut Oral Immunotherapy/Dietary Peanut	0

Percentage of Participants Experiencing Gastrointestinal Adverse Events During the 2-stage Study Sequence (Safety) Secondary · 12 months

Percentage of participants experiencing a gastrointestinal adverse event related to peanut oral immunotherapy (OIT) or dietary peanut

Group	Value	95% CI
Open-label Peanut Oral Immunotherapy/Dietary Peanut	53.33

Percentage of Participants Withdrawing During the 2-stage Study Sequence Due to Gastrointestinal Adverse Events (Safety) Secondary · 12 months

Percentage of participants withdrawing from the study due to a gastrointestinal adverse event related to peanut oral immunotherapy (OIT) or dietary peanut

Group	Value	95% CI
Open-label Peanut Oral Immunotherapy/Dietary Peanut	13.33

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were captured from the time of signing consent through the completion of 12 month treatment protocol.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Open-label Peanut OIT/Dietary Peanut

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (4 terms — click to expand)

Reaction	System	Open-label Peanut OIT/Diet…
Gastrointestinal adverse events	Gastrointestinal disorders	—
Skin adverse events	Skin and subcutaneous tissue disorders	—
Upper respiratory adverse events	Respiratory, thoracic and mediastinal disorders	—
Lower respiratory adverse events	Respiratory, thoracic and mediastinal disorders	—

Data from ClinicalTrials.gov NCT03251508 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Etiology of IgE-Mediated Food Allergy: Potential Therapeutics and Challenges.
   Carnazza M, Werner R, Tiwari RK, Geliebter J, et al · · 2025 · cited 3× · PMID 40004029 · DOI 10.3390/ijms26041563