Novel Treatment for Patients With Peanut Allergy: Intralymphatic Immunotherapy

Phase 1

Withdrawn

• Conditions: Food Allergy Peanut
• Interventions: Biological: Peanut allergen

• Registration Number: NCT04200989
• Lead Sponsor: Scripps Health

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.

Study Timeline

• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-16
• Status Verified: 2021-02
• Study Start: 2021-03-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Last Update Submitted: 2022-11-18
• Last Update Posted: 2022-11-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Peanut allergen	Peanut ILIT

Primary Outcome Measures

Name	Time	Method
Peanut tolerance	4 months	Increase in amount (mg - grams) of peanut ingested without reaction from baseline to one month post ILIT

Trial Locations

Locations (1)

Scripps Clinic; 🇺🇸 San Diego, California, United States