Novel Treatment for Patients With Peanut Allergy: Intralymphatic Immunotherapy

November 18, 2022 updated by: Ronald A Simon, Scripps Health

Intra-lymphatic Immunotherapy for the Management of Peanut Allergy

Use of three intralymphatic injections of peanut allergen one month apart to induce tolerance to peanut in peanut allergic people.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Eligible subject undergo a baseline blinded oral peanut challenge. Then the peanut ILIT as described above. Pretreatment with antihistamines, leukotriene modifier and albuterol before each treatment.

Following the three ILIT peanut injections a repeat blinded oral peanut challenge is performed.

Blood is drawn at each of the 5 study visits for a variety of tests trying to elucidate the mechanism(s) of the induction of tolerance to peanut.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92130
        • Scripps Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

History of peanut allergy Positive prick skin tests or invitro IgE to peanut Positive blinded oral peanut challenge.

-

Exclusion Criteria:

History of

  • life threatening anaphylaxis to peanut Uncontrolled asthma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Peanut ILIT
Biological: Peanut allergen
Intralymphatic immunotherapy injections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peanut tolerance
Time Frame: 4 months
Increase in amount (mg - grams) of peanut ingested without reaction from baseline to one month post ILIT
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Health

Collaborators

The Scripps Research Institute

Investigators

  • Principal Investigator: Simon A Ronald, MD, Scripps Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

December 12, 2019

First Submitted That Met QC Criteria

December 13, 2019

First Posted (Actual)

December 16, 2019

Study Record Updates

Last Update Posted (Actual)

November 22, 2022

Last Update Submitted That Met QC Criteria

November 18, 2022

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-19-7380

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Food Allergy Peanut

Clinical Trials on Peanut allergen

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe