Salvage Peanut Oral Immunotherapy Study (SOIT)

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

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 Overview

• Status: Completed
• Conditions: Peanut Allergy
• Intervention / Treatment: Drug: Peanut OIT

Detailed Description

Salvage Peanut Oral Immunotherapy Study is a single-arm, open label trial of peanut flour oral immunotherapy (OIT) administered for 6 months followed by introduction of dietary peanut for an additional 6 months.

The peanut OIT phase will involve approximately 3 months of dose escalation up to a maintenance dose of 300 mg peanut protein. This is followed by 3 months of daily maintenance dosing with 300 mg of peanut protein. Patients are then transitioned to the dietary peanut phase ingesting common foods containing approximately 300 mg of peanut protein daily.

Safety will be assessed during both peanut OIT and dietary peanut phases with adverse events recorded including gastrointestinal side effects. They will also be monitored for any anaphylaxis or injectable epinephrine administration. Data regarding compliance with peanut OIT will be collected as well.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who have completed an immunotherapy trial for peanut allergy within the last 6 months and are unable to tolerate ≥ 300mg of peanut.
• Age 1-65 years of either sex, any race, any ethnicity. Written informed consent from patient or parent/guardian (if < 18 years) with participant's assent.

Exclusion Criteria:

• Current participation in an interventional study for peanut allergy
• History of a severe anaphylactic reaction to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or SpO2 ≤ 92% at any stage, hypotension, confusion, collapse, loss of consciousness, or incontinence)
• Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease
• Severe asthma (2007 NHLBI Criteria Steps 5 or 6 , Appendix 2)
• Use of B blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
• Significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease) which would put the subject at risk for induction of severe food reactions.

Pregnancy or lactation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Peanut OIT/dietary peanut; Single arm study with all subjects receiving peanut OIT study drug for the initial 6 months. This is followed by daily ingestion of common dietary foods containing approximately 300 mg of peanut protein for an additional 6 months.

Drug: Peanut OIT; 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.; Other Names: Peanut flour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Experiencing Treatment-emergent Adverse Events During the 2-stage Study Sequence (Safety)	Percentage of participants experiencing an adverse event related to peanut oral immunotherapy (OIT) or dietary peanut ingestion	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Missed Doses During the 2-stage Study Sequence (Compliance)	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.	12 months
Percentage of Participants Experiencing Treatment-emergent Adverse Events During the Peanut Oral Immunotherapy Stage	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.	6 months
Percentage of Missed Doses During the Peanut Oral Immunotherapy Stage	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.	6 months
Percentage of Participants Utilizing Emergency Epinephrine Use During the 2-Stage Study Sequence (Safety)	Percentage of participants utilizing epinephrine for treatment of an adverse event related to peanut oral immunotherapy (OIT) or dietary peanut	12 months
Percentage of Participants Experiencing Gastrointestinal Adverse Events During the 2-stage Study Sequence (Safety)	Percentage of participants experiencing a gastrointestinal adverse event related to peanut oral immunotherapy (OIT) or dietary peanut	12 months
Percentage of Participants Withdrawing During the 2-stage Study Sequence Due to Gastrointestinal Adverse Events (Safety)	Percentage of participants withdrawing from the study due to a gastrointestinal adverse event related to peanut oral immunotherapy (OIT) or dietary peanut	12 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Edwin Kim, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): November 23, 2021
• Study Completion (Actual): November 23, 2021

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 11, 2017
• First Posted (Actual): August 16, 2017

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Peanut
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nut and Peanut Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: 17-0195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No