Novel Treatment for Patients With Peanut Allergy: Intralymphatic Immunotherapy

NCT ID: NCT04200989

Last Updated: 2022-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Food Allergy Peanut

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All subjects receive the study intervention: Peanut ILIT.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Peanut ILIT

Group Type EXPERIMENTAL

Peanut allergen

Intervention Type BIOLOGICAL

Intralymphatic immunotherapy injections.

Interventions

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Peanut allergen

Intralymphatic immunotherapy injections.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Scripps Research Institute

OTHER

Sponsor Role collaborator

Scripps Health

OTHER

Sponsor Role lead

Responsible Party

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Ronald A Simon

Emeritus Head, Division of Asthma, Allergy and Immunology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simon A Ronald, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Health

Locations

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Scripps Clinic

San Diego, California, United States

Site Status

Countries

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United States

References

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Senti G, Crameri R, Kuster D, Johansen P, Martinez-Gomez JM, Graf N, Steiner M, Hothorn LA, Gronlund H, Tivig C, Zaleska A, Soyer O, van Hage M, Akdis CA, Akdis M, Rose H, Kundig TM. Intralymphatic immunotherapy for cat allergy induces tolerance after only 3 injections. J Allergy Clin Immunol. 2012 May;129(5):1290-6. doi: 10.1016/j.jaci.2012.02.026. Epub 2012 Mar 30.

Reference Type BACKGROUND
PMID: 22464647 (View on PubMed)

Hylander T, Latif L, Petersson-Westin U, Cardell LO. Intralymphatic allergen-specific immunotherapy: an effective and safe alternative treatment route for pollen-induced allergic rhinitis. J Allergy Clin Immunol. 2013 Feb;131(2):412-20. doi: 10.1016/j.jaci.2012.10.056.

Reference Type BACKGROUND
PMID: 23374268 (View on PubMed)

Lee SP, Choi SJ, Joe E, Lee SM, Lee MW, Shim JW, Kim YJ, Kyung SY, Park JW, Jeong SH, Jung JH. A Pilot Study of Intralymphatic Immunotherapy for House Dust Mite, Cat, and Dog Allergies. Allergy Asthma Immunol Res. 2017 May;9(3):272-277. doi: 10.4168/aair.2017.9.3.272.

Reference Type BACKGROUND
PMID: 28293934 (View on PubMed)

Other Identifiers

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IRB-19-7380

Identifier Type: -

Identifier Source: org_study_id

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