Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE)
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 4 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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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|Eligible Ages||4 Years - 55 Years|
- - Age 4 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.
- - 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.
- - 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Rebecca S Chinthrajah, M.D.|
|Principal Investigator Affiliation||Sean N Parker Center for Allergy and Asthma Center at Stanford|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Hypersensitivity, Food Allergy, Hypersensitivity, Food, Peanut Hypersensitivity, Peanut Allergy|
|Study Website:||View Trial Website|
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 4 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.
Other: Cohort A: Omalizumab
Participants will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with placebo
Other: Cohort B: Omalizumab/Dupilumab
Participants will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with dupilumab.
Other: Cohort C: Dupilumab
Participants will be treated with placebo for 8 weeks, followed by 24 weeks of treatment with dupilumab.
Drug: - Omalizumab
Omalizumab is injected every 2 to 4 weeks
Drug: - Dupilumab
Dupilumab is injected every 2 weeks combination, or placebo.
Other: - Placebo
Placebo is injected every 2 to 4 weeks
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
University of California Los Angeles (UCLA)
Los Angeles, California, 90095
Stacey Zedeck, RN
Sean N. Parker Center for Allergy & Asthma Research at Stanford University
Palo Alto, California, 94304
SNP Center Inquiry
University of California San Diego (UCSD)
San Diego, California, 92123
Amy Grissinger, NP