NCT03181009

Multi OIT to Test Immune Markers After Minimum Maintenance Dose

A Phase 2 Study Multi Oral Immunotherapy in Multi Food Allergic Patients to Test Immune Markers After Minimum Maintenance Dose

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Kari Christine Nadeau, MD PhD · Academic / Other
• Sex: All
• Age: 2 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase 2 multisite study that will be conducted at two centers in the U.S. All subjects will receive oral immunotherapy for their specific food allergies (peanut, milk, egg, soy, wheat, cashew, walnut, almond, hazelnut, cod, salmon, sesame, shrimp). All participants will receive three doses of Omalizumab 4 weeks apart over 8 weeks. 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. Food protein and powder will be obtained and prepared as per Investigational New Drug 14831 and will be in compliance with all applicable regulations. Omalizumab is approved by the European Medicines Agency (European FDA) and by the US FDA. Omalizumab will be dosed according to Genentech Dosing Omalizumab will be provided by the site.

Conditions

• Food Allergy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-07-31
• Primary completion: 2018-12-01
• Completion: 2019-01-30
• First posted: 2017-06-08
• Last updated: 2020-04-20
• Results posted: 2019-09-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study