Multi OIT to Test Immune Markers After Minimum Maintenance Dose

PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 31, 2017

Primary Completion Date

December 1, 2018

Study Completion Date

January 30, 2019

Conditions
Food Allergy
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.

Trial Locations (2)

90095

UCLA, Los Angeles

94040

Sean N. Parker Center for Allergy and Asthma Research at Stanford, Mountain View

All Listed Sponsors
collaborator

University of California, Los Angeles

OTHER

lead

Kari Christine Nadeau, MD PhD

OTHER

NCT03181009 - Multi OIT to Test Immune Markers After Minimum Maintenance Dose | Biotech Hunter | Biotech Hunter