Clinical Study Using Biologics to Improve Multi OIT Outcomes

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    110
  • sponsor
    Stanford University
Updated on 1 March 2022
biological factors
allergen
skin prick
food allergy
allergy test
serum ige
prick skin
skin prick test
omalizumab
peanut allergy
milk allergy
serum ige measurement
biologics
dupilumab
allergy to peanuts
skin pricking

Summary

Food allergy (FA) is a serious public health concern that causes potentially-life threatening reactions in affected patients. The prevalence of food allergy in the United States (U.S.) has increased substantially and now affects 15 million patients:4-8% of children (6 million children, 30% with multiple food allergies) and about 9% of adults. This is a prospective Phase 2, single-center, multi-allergen OIT study in participants with proven allergies to 2 or 3 different foods in which one must be a peanut. The total of participants in the clinical study will be 110, ages 5 to 55 years with a history of multiple food allergies of 2 to 3 different foods including peanut. Allergy will be confirmed by FA-specific IgE levels and positive skin prick test (SPT). Enrolled participants must be positive during the Double-blind Placebo-controlled Food challenge (DBPCFC) at or before the 300 mg (444 mg cumulative) dosing level of FA proteins.

Description

This is a prospective Phase 2, single-center, multi-allergen OIT study in participants with proven allergies to 2 or 3 different foods in which one must be peanut. The total population will be 110 participants, ages 5 to 55 years that present with a history of multiple food allergies of 2 or 3 different foods including peanut, food-allergen (FA)-specific IgE levels, and positive skin prick test (SPT).

Enrolled participants must react positively during DBPCFCs at or before the 300 mg (444 mg cumulative) dosing level of FA proteins of 2 or 3 allergens in which one must be a peanut.

There will be three study cohorts, all will be double blinded:

Cohort A (50 participants) will be treated with omalizumab for 8 weeks followed by 24 weeks of treatment with placebo. Cohort B (50 participants) will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with dupilumab. Cohort C (10 participants) will be treated with placebo for 8 weeks followed by 24 weeks treatment with dupilumab. All cohorts will receive multifood allergen oral immunotherapy.

Details
Condition Hypersensitivity, Food Allergy, Hypersensitivity, Food, Peanut Hypersensitivity, Peanut Allergy
Treatment Placebo, omalizumab, Dupilumab
Clinical Study IdentifierNCT03679676
SponsorStanford University
Last Modified on1 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 5 through 55 years (inclusive)
Clinical history of peanut allergy and 1 or 2 additional foods from the following foods: milk, almond, shellfish, fish, cashew, hazelnut, egg, walnut, sesame seeds, soy, and wheat. Allergy to milk and egg is defined as unable to tolerate both cooked and uncooked forms
Positive allergy test determined by
ImmunoCAP serum IgE level >4 kUA/L for each allergen within the past 12 months OR
Skin prick test (SPT) 6 mm wheal diameter to each allergen
A clinical reaction during a DBPCFC to small doses of food defined as a cumulative dose of =/<444 mg food protein
No clinical reaction observed during the placebo (oat) challenge
Subject and/or parent guardian must be able to understand and provide informed consent
Written informed consent from adult participants
Written informed consent from parent/guardian for minor participants
Written assent from minor participants as appropriate (e.g., at and above the age of 7 years)
Use of effective birth control by female participants of childbearing potential

Exclusion Criteria

History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
Individuals less than 15 kg in weight at start of the study
History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise or requiring intubation
History of chronic disease (other than asthma, atopic dermatitis or allergic rhinitis) that is, or is at significant risk of becoming, unstable or requiring a change in chronic therapeutic regimen
History of eosinophilic esophagitis (EoE), another eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia (e.g., difficulty swallowing, food "getting stuck"), or recurrent gastrointestinal symptoms of undiagnosed etiology
Severe asthma (NAEPP EPR-3 Medication Criteria Steps 5 or 6)
Mild or moderate asthma (NAEPP EPR-3 Medication Criteria Steps 1-4), if uncontrolled or difficult to control
Uncontrolled asthma as evidenced by
FEV1 < 80% of predicted, or ratio of FEV1 to forced vital capacity (FEV1/FVC) < 75% of predicted, with or without controller medications (only for age 6 or greater and able to do spirometry reliably. If unable to do spirometry, PEF of >80% is acceptable) or
One overnight admission to a hospital in the past year for asthma or
Emergency room (ER) visit for asthma within six months prior to screening
Inability to tolerate biological (antibody) therapies
Use of immunomodulator therapy (not including corticosteroids)
Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
Current participation or within the last 4 months in any other interventional study
Pregnancy or lactation
Allergy to oat (placebo in DBPCFC)
Use of investigational drugs within 16 weeks of participation
In build up phase of immunotherapy for aeroallergens or venom
Clear my responses

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