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Salvage Peanut Oral Immunotherapy Study (SOIT)

Primary Purpose

Peanut Allergy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Peanut OIT
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring Peanut

Eligibility Criteria

1 Year - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of North Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peanut OIT/dietary peanut

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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
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
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

Full Information

First Posted
August 10, 2017
Last Updated
January 4, 2023
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT03251508
Brief Title
Salvage Peanut Oral Immunotherapy Study
Acronym
SOIT
Official Title
Salvage Peanut Oral Immunotherapy Study: A Single-arm, Open Label Trial of Peanut Flour With 6 Month Active Treatment and 6 Month Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
November 23, 2021 (Actual)
Study Completion Date
November 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy
Keywords
Peanut

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edwin Kim, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Salvage Peanut Oral Immunotherapy Study

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