FARE Clinical Trial Finder
Clinical Study Using Biologics to Improve Multi OIT Outcomes
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 3-5% of adults. This is a prospective Phase 2, single-center, multi-allergen OIT in participants with proven allergies to up to 3 different foods in which one must be a peanut. The total of participants in the clinical study will be 160, ages 4 to 21 years with a history of multiple food allergies of up to 3 different foods including peanut. An additional 20 multi-food allergic participants and 20 non-allergic controls that will not undergo OIT, will be followed to help interpret immune mechanisms of OIT. Allergy will be confirmed by FA-specific IgE levels and positive skin prick test (SPT). Enrolled participants must be positive at or before the 100 mg (144 mg cumulative) a dosing level of FA proteins.
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.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||6 Years - 21 Years|
- - Age 6 through 21 years (inclusive).
- - Clinical history of peanut allergy and 1-2 additional foods from the following foods: milk, almond, cashew, hazelnut, pecan, 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 PRACTALL DBPCFC to small doses of food defined as a dose of =/<144 mg food protein.
- - No clinical reaction observed during the placebo (oat) challenge.
- - Written informed consent from adult participants.
- - Written informed consent from parent/guardian for minor participants.
- - Written assent from minor participants as appropriate (e.g., above the age of 7 years or the applicable age per local regulatory requirements).
- - Use of effective birth control by female participants of childbearing potential.
- - History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension.
- - History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of Screening.
- - 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 (2007 NHLBI Criteria Steps 5 or 6) Mild or moderate asthma (2007 NHLBI Criteria Steps 1-4), if uncontrolled or difficult to control.
- - Inability to tolerate biological (antibody) therapies.
- - Use of immunomodulator therapy (not including corticosteroids).
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.
|Kari C Nadeau, M.D., Ph.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.
|Overall Status||Not yet recruiting|
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 up to 3 different foods in which one must be peanut. The total population will be 160 participants, ages 6 to 21 years that present with a history of multiple food allergies of up to 3 different foods including peanut, food-allergen (FA)-specific IgE levels, and positive skin prick test (SPT). An additional 20 matched multi-food allergic participants and 20 non-allergic controls that will not undergo OIT, will be followed to help interpret immune mechanisms of OIT. Enrolled participants must react positively during DBPCFCs at or before the 100 mg (144 mg cumulative) dosing level of FA proteins of up to 3 allergens in which one must be a peanut. There will be four study cohorts: Cohort A (40 participants) will be treated with omalizumab for 8 weeks, followed by an additional 16 weeks of treatment with omalizumab. Cohort B (40 participants) will be treated with omalizumab for 8 weeks, followed by 16 weeks of treatment with dupilumab. Cohort C (40 participants) will be treated with dupilumab for 8 weeks, followed by an additional 16 weeks of treatment with dupilumab. Cohort D (40 participants) will be treated with placebo for 24 weeks.
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Sharon Chinthrajah, M.D.
For additional contact information, you can also visit the trial on clinicaltrials.gov.