Can a biologic drug help peanut allergy sufferers tolerate nuts?
NCT ID NCT07015996
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times
Summary
This Phase 2 trial tests whether adding tezepelumab (a biologic drug) to peanut oral immunotherapy (OIT) helps people with peanut allergy tolerate more peanut without symptoms. 62 participants aged 12 to 55 will first receive tezepelumab or placebo alone, then both groups undergo peanut OIT for 56 weeks, followed by a 12-week withdrawal period. The main goal is to see if participants can eat a cumulative dose of 4000 mg of peanut protein without symptoms after stopping all treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tezepelumab (a biologic drug) and peanut oral immunotherapy (gradual exposure to peanut protein)
- What this could lead to
- If successful, this could point toward a treatment that allows people with peanut allergy to safely eat small amounts of peanut without severe reactions.
- What could go wrong
- This is an early Phase 2 proof-of-concept trial with only 62 participants, so results may not apply to everyone. There is also a risk of allergic reactions during the oral immunotherapy phase.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 62 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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May 2029
An estimate. End dates often move.
- 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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12 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: 1. Participant and/or parent/legal guardian must be able to understand and provide informed consent (parental permission and informed assent of minor, if applicable). 2. Age 12 to 55 years inclusive with a personal history of an allergic reaction to peanut ingestion 3. A positive reaction at or below ingestion of 100 mg of peanut protein in a single dose (≤ 144 mg cumulative dose) during the Screening DBPCFC 4. A negative challenge to the placebo (oat) during the Screening DBPCFC 5. Sensitization to peanut as evidenced by either one of the following: 1. positive sIgE to Ara h2 ≥ 0.35 kU/L by ImmunoCAPTM testing, or 2. wheal ≥ 3 mm on skin prick test to peanut extract compared to a negative control 6. Female participants of childbearing potential must have a negative pregnancy test upon study entry 7. Female participants with reproductive potential must agree to use an FDA approved method of contraception for the duration of the study 8. Willing and able to comply with the study protocol requirements 9. Participants with other food allergies must agree to continue avoidance of these food items from their diet to avoid confounding the safety and efficacy data of the study Exclusion Criteria: 1. Currently in build-up phase of aeroallergen immunotherapy 2. Current food allergen immunotherapy or use of any food allergen immunotherapy within the past 12 months 3. Pregnant, planning a pregnancy during the study, or breast-feeding 4. History of intolerance, hypersensitivity, or allergic reactions to tezepelumab, or the inactive ingredients (excipients) of tezepelumab, other IgG biologics, or rescue medications and their excipients 5. Allergy to oat (participant reported) 6. History of severe systemic allergic reaction to peanut with symptoms including the need for mechanical ventilation and/or severe hypotension requiring intensive care unit admission 7. Asthma requiring high dose inhaled corticosteroid therapy for control (2007 NHLBI Criteria Steps 5 or 6 in adults and adolescents) 8. History of a life-threatening asthma attack within 12 months prior to screening (e.g., requiring an ICU admission or intubation with mechanical ventilation), need for oral corticosteroids for asthma management within the last 6 months, or current Asthma Control Test score less than 19 at screening 9. History of ischemic cardiovascular disease or other cardiac disease, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study 10. History of eosinophilic gastrointestinal disease at screening 11. History of disease affecting the immune system such as autoimmune disease (e.g., systemic lupus erythematosus), immune complex disease (e.g., serum sickness), or immunodeficiency, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study 12. History of malignancy of any type, excluding basal cell and squamous cell cancers of the skin that only required surgical excision or in situ carcinoma of the cervix study provided that curative therapy was completed at least 12 months prior to screening 13. Current known helminth infection 14. Positive QuantiFERON - TB Gold test or TB Gold Plus, or T-SPOT® TB test unless the potential participant has been treated with appropriate chemoprophylaxis. In the case of an indeterminate or borderline Interferon Gamma Release Assay (IGRA), an IGRA may be repeated. 15. Any of the following: 1. HIV 2. Current or prior infection with hepatitis B virus (HBV) 3. Current or prior infection with hepatitis C virus (HCV), except adequately treated HCV with sustained virologic response ≥ 12 weeks. 16. Active liver disease, defined as either: 1. AST, ALT, and/or Alk phos \>2x ULN, or 2. other active liver disease which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study 17. Any of the following: 1. Current use of beta-blockers, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers 2. Received any investigational product within the past 4 months or 5 half-lives (whichever is longer) prior to screening 3. Received systemic corticosteroids within 14 days prior to screening 4. Receipt of immunoglobulin or other blood product within 30 days prior to screening 5. Receipt of live attenuated vaccine within 30 days prior to screening 6. Use of an immunosuppressant or immunomodulating drug within 30 days prior to screening 7. Use of biologics targeting the human immune system within the past 12 months prior to screening 8. Use of any herbal medications, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study 18. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology
RECRUITINGLittle Rock, Arkansas, 72202, United States
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Boston Children's Hospital: Allergy and Asthma Program
NOT_YET_RECRUITINGBoston, Massachusetts, 02115, United States
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Cincinnati Children's Hospital Medical Center: Division of Allergy and Immunology
RECRUITINGCincinnati, Ohio, 45229, United States
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Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology
RECRUITINGNew York, New York, 10029-6574, United States
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Johns Hopkins Children's Center: Department of Allergy & Immunology
RECRUITINGBaltimore, Maryland, 21287, United States
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Massachusetts General Hospital: Department of Medicine: Allergy & Clinical Immunology Unit
RECRUITINGBoston, Massachusetts, 02114, United States
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North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
RECRUITINGChapel Hill, North Carolina, 27599, United States
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The University of Michigan: Division of Allergy and Clinical Immunology
NOT_YET_RECRUITINGAnn Arbor, Michigan, 48105, United States
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University of California, Los Angeles: Department of Medicine, Division of Clinical Immunology and Allergy
NOT_YET_RECRUITINGLos Angeles, California, 90095, United States
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University of Texas Southwestern Medical Center: Division of Allergy and Immunology
NOT_YET_RECRUITINGDallas, Texas, 75390-9063, United States
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