Novel Treatment for Patients With Peanut Allergy: Intralymphatic Immunotherapy

NCT04200989 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: IRB-19-7380
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Food Allergy Peanut

Outcome Measures

Primary Outcomes (1)

• Peanut tolerance

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

  4 months

Study Arms (1)

Treatment

EXPERIMENTAL

Peanut ILIT

Biological: Peanut allergen

Interventions

Peanut allergen BIOLOGICAL

Intralymphatic immunotherapy injections.

Treatment

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of
• life threatening anaphylaxis to peanut Uncontrolled asthma

Sponsors & Collaborators

• Scripps Health: lead
• The Scripps Research Institute: collaborator

Study Sites (1)

Scripps Clinic

San Diego, California, 92130, United States

Location

Related Publications (3)

• 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.

  PMID: 22464647 BACKGROUND

• 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.

  PMID: 23374268 BACKGROUND

• 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.

  PMID: 28293934 BACKGROUND

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Simon A Ronald, MD

  Scripps Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Head, Division of Asthma, Allergy and Immunology

Model Details: All subjects receive the study intervention: Peanut ILIT.

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 16, 2019
• Study Start: March 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 22, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)