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Multi OIT to Test Immune Markers After Minimum Maintenance Dose
Not Recruiting
Trial ID: NCT03181009
Purpose
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.
Official Title
A Phase 2 Study Multi Oral Immunotherapy in Multi Food Allergic Patients to Test Immune Markers After Minimum Maintenance Dose
Eligibility
Inclusion Criteria:
- Aged 2 to 25 years with clinical history of allergy to at least two of the following:
milk and/or egg and/or peanut and/or almond and/or wheat and/or cashew and/or sesame
seed and/or soy and/or pecan and/or walnut and/or hazelnut and/or shrimp and/or cod
and/or salmon and
- Sensitivity to food allergens documented by a positive skin prick test result greater
than or equal to 6mm wheal diameter to each allergen or
- ImmunoCAP IgE level >4kU/L for each allergen and
- If female of child bearing potential, a negative urine pregnancy test before being
allowed to participate in the study (week 0) and
- A plan to remain in the study area of the research center during the trial and
- Be trained on the proper use of the Epinephrine autoinjector and agree to follow epi
training to be allowed to enroll in the study and
- If female of child-bearing potential, willing to be compliant with a
medically-approved method of contraception (please see Pregnancy section in this IND
document) and
- Agree to eliminate other known food allergens from subject's diet so as not to
confound the safety and efficacy data from the study and
- Avoid open or blinded food challenges to food allergens
Exclusion Criteria:
- Previous anaphylactic reaction to Omalizumab
- A history of severe anaphylaxis to food allergens that will be desensitized in this
study requiring intubation or admission to an ICU, frequent allergic or non-allergic
urticaria, or history consistent with poorly controlled persistent asthma
- Unstable angina, significant arrhythmia, uncontrolled hypertension, chronic sinusitis,
or other chronic or immunological diseases that, in the judgment of the investigator,
might interfere with the evaluation or administration of the test drug or pose
additional risk to the subject (e.g., gastrointestinal or gastroesophageal disease,
chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic
pulmonary disease)
- An average forced expiratory volume at one second (FEV1) or peak expiratory flow rate
(PEF) less than 80% predicted (moderate persistent asthma) with or without controller
medication (if able to perform the maneuver) at screening, or a food challenge visit
- Current users of oral, intramuscular, or intravenous corticosteroids, tricyclic
antidepressants, or are taking a beta-blocker (oral or topical)
- Routinely using medication that could induce adverse gastrointestinal reactions during
the study
- Refusing to sign or follow the Epinephrine autoinjector Training Form
- Pregnant or breast feeding women
- Unwilling to avoid other allergens outside this study
- Concurrent/prior use of immunomodulatory therapy (within 6 months)
- A diagnosis of eosinophilic esophagitis, eosinophilic colitis, or eosinophilic
gastritis.
Intervention(s):
drug: Omalizumab
drug: Food Flour Allergens
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305