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Multi OIT to Test Immune Markers After Minimum Maintenance Dose

NCT03181009 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-27

Study results available
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Summary

Few studies have been conducted to optimize safety of multiple food allergen oral immunotherapy (OIT) in conjunction with Omalizumab as well as to identify the immunological mechanism(s) underlying any long-lasting effects of OIT. To address these issues in the field of food allergy research, we have designed this study to test whether: 1) Omalizumab improves the safety of multiple food allergen OIT in subjects with multi food allergies, 2) Omalizumab treatment with multiple food allergen OIT is associated with the ability to use a lower maintenance dose of each food allergens in the OIT regimen, particularly in younger subjects with food allergies.

Conditions

Interventions

DRUG

Omalizumab

All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.

DRUG

Food Flour Allergens

The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle.

Sponsors & Collaborators

Principal Investigators

  • Kari C Nadeau, MD PhD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2018-12-01
Completion
2019-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03181009 on ClinicalTrials.gov