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.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||2 Years - 25 Years|
- - 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
- 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.
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.
|Kari Christine Nadeau|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Kari C Nadeau, MD PhD|
|Principal Investigator Affiliation||Stanford University|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
This is a phase 2 multisite study that will be conducted at two centers in the U.S. All subjects will receive oral immunotherapy for their specific food allergies (peanut, milk, egg, soy, wheat, cashew, walnut, almond, hazelnut, cod, salmon, sesame, shrimp). All participants will receive three doses of Omalizumab 4 weeks apart over 8 weeks. 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.#46; 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.#46;B. Food protein and powder will be obtained and prepared as per Investigational New Drug 14831 and will be in compliance with all applicable regulations. Omalizumab is approved by the European Medicines Agency (European FDA) and by the US FDA. Omalizumab will be dosed according to Genentech Dosing Omalizumab will be provided by the site.
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.