Salvage Peanut Oral Immunotherapy Study

NCT ID: NCT03251508

Last Updated: 2023-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-03
• Study Completion Date: 2021-11-23

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.

Conditions

Peanut Allergy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Peanut OIT

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Peanut flour

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edwin Kim, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-0195

Identifier Type: -

Identifier Source: org_study_id