Could a shot help people with multiple food allergies eat peanuts safely?
NCT ID NCT03881696
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested whether omalizumab (Xolair), an allergy drug, helps people with peanut and at least two other food allergies eat those foods without severe reactions. Over 470 participants aged 1 to 55 received omalizumab or a placebo, and some also got oral immunotherapy. The goal was to see if they could tolerate a dose of peanut protein without symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- omalizumab (Xolair) and multi-allergen oral immunotherapy
- What this could lead to
- If successful, this could provide a new treatment option to help people with multiple food allergies tolerate small amounts of allergenic foods without severe reactions.
- What could go wrong
- This is a completed phase 3 trial, but results may not apply to all food allergies or ages. Omalizumab is not a cure and requires ongoing injections; risks include allergic reactions and side effects from the drug.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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471 people
The number who actually took part.
- Started
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Jul 2019
- Finished
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Jul 2025
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Individuals who meet all of the following criteria are eligible for enrollment as study participants: 1. Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable; 2. Peanut allergic: participant must meet all of the following criteria to minimize the chance that the participant will develop natural tolerance to peanut over the course of the study: 1. Positive skin prick test (SPT) defined as ≥4 mm wheal greater than saline control) to peanut, 2. Positive peanut immunoglobulin E (IgE), ≥6 kUA/L, at Screening or within three months of Screening, determined by ImmunoCap, and 3. Positive double-blind placebo-controlled food challenge (DBPCFC), defined as experiencing dose-limiting symptoms at a single dose of ≤100 mg of peanut protein. 3. Allergic to at least two of the six other foods (milk, egg, wheat, cashew, hazelnut, walnut): each participant must meet all of the following criteria for at least two of the six other foods to minimize the chance that the participant will develop natural tolerance to at least two of the six other foods over the course of the study: 1. Positive SPT (≥4 mm wheal) to food, 2. Positive food specific IgE (≥6 kUA/L) at Screening or within three months of Screening, determined by ImmunoCap, and 3. Positive DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg of food protein. 4. With body weight (as measured at Screening) and total serum IgE level (as measured within three months of Screening) suitable for omalizumab dosing; 5. If female of child-bearing potential, must have a negative urine or serum pregnancy test; 6. For women of childbearing potential, must agree to,during the treatment period and for 60 days after the last dose of study drug: * remain abstinent (refrain from heterosexual intercourse), or * use acceptable contraceptive methods (barrier methods, or * oral, injected, or implanted hormonal methods of contraception, or * other forms of hormonal contraception that have comparable efficacy). 7. Plan to remain in the study area of an OUtMATCH clinical research unit (CRU) during the trial; and 8. Be willing to be trained on the proper use of an epinephrine autoinjector for the duration of the study. Exclusion Criteria: Individuals who meet any of the following criteria are not eligible for enrollment as study participants: 1. Inability or unwillingness of a participant and/or parent/legal guardian to give written informed consent and/or assent or comply with the study protocol; 2. Clinically significant laboratory abnormalities at Screening; 3. Dose-limiting symptoms to the placebo portion of the Screening DBPCFC; 4. Sensitivity or suspected/known allergy to any ingredients (including excipients) of the * active or placebo oral food challenge (OFC) material, * multi-allergen oral immunotherapy (OIT), or * drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin). * Note: Guidance for determination of sensitivity to excipients will be detailed in the study's Manual of Procedures (MOP). 5. Poorly controlled atopic dermatitis (AD) at Screening, per the Principal Investigator's PI's) discretion; 6. Poorly controlled or severe asthma/wheezing at Screening, defined by at least one of the following criteria: 1. Global Initiative for Asthma (GINA) criteria regarding asthma control latest guidelines, 2. History of two or more systemic corticosteroid courses within six months of Screening or one course of systemic corticosteroids within three months of Screening to treat asthma/wheezing, 3. Prior intubation/mechanical ventilation for asthma/wheezing, 4. One hospitalization or Emergency Department (ED) visit for asthma/wheezing within six months of Screening, 5. Forced expiratory volume in one second (FEV1) \<80 percent of predicted or FEV1/forced vital capacity (FVC) \<75 percent, with or without controller medications (only for participants who are aged seven years or older and are able to perform spirometry), or 6. Inhaled corticosteroid (ICS) dosing of \>500 mcg daily fluticasone (or equivalent ICS based on the National Institutes of Health, National Heart, Lung, and Blood Institute (NHLBI) dosing chart). 7. History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise or requiring intubation; 8. Treatment with a burst of oral, intramuscular (IM), or intravenous (IV) steroids of more than two days for an indication other than asthma/wheezing within 30 days of Screening; 9. Currently receiving oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, or beta-blockers (oral or topical); 10. Past or current history of eosinophilic gastrointestinal (GI) disease within three years of Screening; 11. Past or current history of cancer, or currently being investigated for possible cancer; 12. Previous adverse reaction to omalizumab; 13. Past or current history of any immunotherapy to any of the foods being treated in this study (e.g., OIT, sublingual immunotherapy \[SLIT\], EPIT) within 6 months of Screening; 14. Treatment with monoclonal antibody therapy, such as omalizumab (Xolair®), dupilumab (Dupixent®), benralizumab (Fasenra™), mepolizumab (Nucala®), reslizumab (Cinqair®), or other immunomodulatory therapy within six months of Screening; 15. Currently on "build-up phase" of inhalant allergen immunotherapy (i.e., has not reached maintenance dosing). Note: Individuals tolerating maintenance allergen immunotherapy can be enrolled; 16. Inability to discontinue antihistamines for the minimum wash-out periods required for SPTs,or OFCs; 17. Current participation in another therapeutic or interventional clinical trial or participation within 90 days of Screening; 18. Use of investigational drugs within 24 weeks of Screening; 19. Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of omalizumab or placebo for omalizumab; 20. Has a first-degree relative already enrolled in the study; or 21. Past or current medical problems (e.g., severe latex allergy), history of other chronic diseases (other than asthma/wheezing, AD, or rhinitis) requiring therapy (e.g., heart disease, diabetes), findings from physical assessment, or abnormalities in clinical laboratory testing that are not listed above, which, in the opinion of the PI, may: * pose additional risks from participation in the study, * may interfere with the participant's ability to comply with study requirements, or * may impact the quality or interpretation of the data obtained from the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology
Little Rock, Arkansas, 72202, United States
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Children's Hospital of Philadelphia: Division of Allergy and Immunology
Philadelphia, Pennsylvania, 19104, United States
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Emory University School of Medicine: Children's Healthcare of Atlanta Pediatrics
Atlanta, Georgia, 30307, United States
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Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology
New York, New York, 10029, United States
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Johns Hopkins Children's Center: Department of Allergy & Immunology
Baltimore, Maryland, 21287, United States
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Massachusetts General Hospital, Department of Medicine: Allergy & Clinical Immunology Unit
Boston, Massachusetts, 02114, United States
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National Jewish Health: Division of Pediatric Allergy and Clinical Immunology
Denver, Colorado, 80206, United States
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North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
Chapel Hill, North Carolina, 27599-7000, United States
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Stanford School of Medicine: Sean N. Parker Center for Allergy & Asthma Research
Stanford, California, 94305, United States
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University of Texas Southwestern Medical Center: Division of Allergy and Immunology
Dallas, Texas, 75390, United States
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