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Novel Treatment for Patients With Peanut Allergy: Intralymphatic Immunotherapy

Primary Purpose

Food Allergy Peanut

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Peanut allergen

About this trial

This is an interventional treatment trial for Food Allergy Peanut

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Scripps Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Peanut ILIT

Outcomes

Primary Outcome Measures

Peanut tolerance

Increase in amount (mg - grams) of peanut ingested without reaction from baseline to one month post ILIT

Secondary Outcome Measures

Full Information

NCT ID

NCT04200989

First Posted

December 12, 2019

Last Updated

November 18, 2022

Sponsor

Scripps Health

Collaborators

The Scripps Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT04200989

Brief Title

Novel Treatment for Patients With Peanut Allergy: Intralymphatic Immunotherapy

Official Title

Intra-lymphatic Immunotherapy for the Management of Peanut Allergy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of funding

Study Start Date

March 1, 2021 (Anticipated)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Scripps Health

Collaborators

The Scripps Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

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

Food Allergy Peanut

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

All subjects receive the study intervention: Peanut ILIT.

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Peanut ILIT

Intervention Type

Biological

Intervention Name(s)

Peanut allergen

Intervention Description

Intralymphatic immunotherapy injections.

Primary Outcome Measure Information:

Title

Peanut tolerance

Description

Increase in amount (mg - grams) of peanut ingested without reaction from baseline to one month post ILIT

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Simon A Ronald, MD

Organizational Affiliation

Scripps Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Scripps Clinic

City

San Diego

State/Province

California

ZIP/Postal Code

92130

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22464647

Citation

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.

Results Reference

background

PubMed Identifier

23374268

Citation

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.

Results Reference

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PubMed Identifier

28293934

Citation

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.

Results Reference

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Learn more about this trial

Novel Treatment for Patients With Peanut Allergy: Intralymphatic Immunotherapy

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