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Can a biologic drug help peanut allergy sufferers tolerate nuts?

NCT ID NCT07015996

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 62 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

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

12 to 55 years

Sex

Anyone

Healthy volunteers

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

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.

food allergy Peanut Hypersensitivity

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.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology

    RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Boston Children's Hospital: Allergy and Asthma Program

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02115, United States

  • Cincinnati Children's Hospital Medical Center: Division of Allergy and Immunology

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology

    RECRUITING

    New York, New York, 10029-6574, United States

  • Johns Hopkins Children's Center: Department of Allergy & Immunology

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Massachusetts General Hospital: Department of Medicine: Allergy & Clinical Immunology Unit

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • The University of Michigan: Division of Allergy and Clinical Immunology

    NOT_YET_RECRUITING

    Ann Arbor, Michigan, 48105, United States

  • University of California, Los Angeles: Department of Medicine, Division of Clinical Immunology and Allergy

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • University of Texas Southwestern Medical Center: Division of Allergy and Immunology

    NOT_YET_RECRUITING

    Dallas, Texas, 75390-9063, United States

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