Multi OIT to Test Immune Markers After Minimum Maintenance Dose

Part of paid clinical trials in Los Angeles, California.

Sponsor
Andrew Long, PharmD
Study ID
NCT03181009
Phase
PHASE2
Status
Completed

Conditions

  • Food Allergy

Eligibility Criteria

Sex
ALL
Age
2 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    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.
  • Food Flour Allergens — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 31, 2017
Status verified
Apr 2020
Primary completion
Dec 1, 2018
Completion
Jan 30, 2019

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A (300 mg maintenance dose)
    After initial therapy with omalizumab Group A subjects will escalate their food flour allergens to 300 mg in 18 weeks.
  • Active Comparator: Group B (1200 maintenance dose)
    After initial therapy with omalizumab Group B subjects will escalate their food flour allergens to 1200 mg in 18 weeks.

Primary Outcome Measure

Change in Allergen-specific Serum IgG4 and IgE [ Time Frame: 18 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90095-
Sean N. Parker Center for Allergy and Asthma Research at StanfordMountain ViewCalifornia94040-

Find similar trials in Los Angeles, CA

By research site
UCLA· Los Angeles, CASean N. Parker Center for Allergy and Asthma Research at Stanford· Mountain View, CA

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