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Peanut AllergyPhase 2ZENITHNCT07015996

Efficacy of Tezepelumab in Peanut Oral Immunotherapy

A Phase 2 study testing Tezepelumab and Peanut Oral Immunotherapy (OIT) in people with Peanut Allergy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

The proposed study is a proof-of-concept Phase 2, double-blind, randomized placebo-controlled clinical trial evaluating the safety and efficacy of tezepelumab and peanut Oral Immunotherapy (OIT) for the treatment of peanut allergy. Read more about this study

Who is it for?
Ages 12 to 55 years
Conditions the study is for
Peanut Allergy
What is being tested?
Tezepelumab and Peanut Oral Immunotherapy (OIT)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
10 sitesUnited States
Study dates
27 Jul 2026to May 2029
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 55 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Participant and/or parent/legal guardian must be able to understand and provide informed consent (parental permission and informed assent of minor, if applicable).
  • Age 12 to 55 years inclusive with a personal history of an allergic reaction to peanut ingestion
  • 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
  • A negative challenge to the placebo (oat) during the Screening DBPCFC
  • Sensitization to peanut as evidenced by either one of the following:
  • positive sIgE to Ara h2 ≥ 0.35 kU/L by ImmunoCAPTM testing, or
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  • wheal ≥ 3 mm on skin prick test to peanut extract compared to a negative control
  • Female participants of childbearing potential must have a negative pregnancy test upon study entry
  • Female participants with reproductive potential must agree to use an FDA approved method of contraception for the duration of the study
  • Willing and able to comply with the study protocol requirements
  • 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

Who cannot join

  • Currently in build-up phase of aeroallergen immunotherapy
  • Current food allergen immunotherapy or use of any food allergen immunotherapy within the past 12 months
  • Pregnant, planning a pregnancy during the study, or breast-feeding
  • 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
  • Allergy to oat (participant reported)
  • 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
Show all 31Show fewer
  • Asthma requiring high dose inhaled corticosteroid therapy for control (2007 NHLBI Criteria Steps 5 or 6 in adults and adolescents)
  • 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
  • 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
  • History of eosinophilic gastrointestinal disease at screening
  • 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
  • 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
  • Current known helminth infection
  • 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.
  • Any of the following:
  • HIV
  • Current or prior infection with hepatitis B virus (HBV)
  • Current or prior infection with hepatitis C virus (HCV), except adequately treated HCV with sustained virologic response ≥ 12 weeks.
  • Active liver disease, defined as either:
  • AST, ALT, and/or Alk phos >2x ULN, or
  • 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
  • Any of the following:
  • Current use of beta-blockers, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers
  • Received any investigational product within the past 4 months or 5 half-lives (whichever is longer) prior to screening
  • Received systemic corticosteroids within 14 days prior to screening
  • Receipt of immunoglobulin or other blood product within 30 days prior to screening
  • Receipt of live attenuated vaccine within 30 days prior to screening
  • Use of an immunosuppressant or immunomodulating drug within 30 days prior to screening
  • Use of biologics targeting the human immune system within the past 12 months prior to screening
  • 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
  • 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

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

10 sites in 1 country

United States10 sites, 10 recruiting

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

    Ann Arbor, Michigan, 48105

    Lea Franco, 734-615-2592, Foodallergytrials@med.umich.edu

    Ian Slack, MD

    Not yet recruiting

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

    Baltimore, Maryland, 21287

    Paul Jones, 410-502-1711, pjones48@jh.edu

    Bob Wood, MD

    Recruiting

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

    Boston, Massachusetts, 02114

    Andrew Kim, 617-643-8683, akim90@mgh.harvard.edu

    Sarita Patil, MD

    Recruiting

  • Boston Children's Hospital: Allergy and Asthma Program

    Boston, Massachusetts, 02115

    Isabella Viola, 617-355-1734, Isabella.Viola@childrens.harvard.edu

    Rima Rachid, MD

    Not yet recruiting

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

    Chapel Hill, North Carolina, 27599

    Latoya Obende, 919-962-4409, Latoya_obende@med.unc.edu

    Edwin Kim, MD

    Recruiting

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

    Cincinnati, Ohio, 45229

    Jenny Duncan, 513-517-1146, Jenny.Duncan@cchmc.org

    Amal Assa'ad, MD

    Recruiting

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

    Dallas, Texas, 75390-9063

    Not yet recruiting

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

    Little Rock, Arkansas, 72202

    Marissa Pilcher, 501-364-3886, PilcherMR@archildrens.org

    Stacie Jones, MD

    Recruiting

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

    Los Angeles, California, 90095

    Stacey Zedeck, (310) 794-5561, uclafoodallergy@mednet.ucla.edu

    Maria Garcia-Lloret, MD

    Not yet recruiting

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

    New York, New York, 10029-6574

    Tejal Schwartz, 212-241-9149, tejal.schwartz@mssm.edu

    Scott Sicherer, MD

    Recruiting

Other trials in United States

About this study

Official title: Efficacy of Tezepelumab in Peanut Oral Immunotherapy: a Double-Blind, Randomized, Placebo-Controlled Trial

The proposed study is a proof-of-concept Phase 2, double-blind, randomized placebo-controlled clinical trial evaluating the safety and efficacy of tezepelumab and peanut Oral Immunotherapy (OIT) for the treatment of peanut allergy. Study participation is divided into 3 periods: (i) a monotherapy period comprised of injections of either Tezepelumab or placebo from week 0 to week 8, (ii) followed by a combination therapy period comprised of 56 weeks during which peanut OIT is built up and maintained, and (iii) a treatment withdrawal period comprised of 12 weeks. This study will enroll 62 peanut-allergic individuals from 12 to 55 years of age who experience dose-limiting symptoms to <=100 mg of peanut protein in a single dose (<= 144 mg cumulative dose) as assessed by DBPCFC.

The primary objective is to determine whether 56 weeks of tezepelumab plus peanut OIT as compared to 56 weeks of placebo plus peanut OIT induces sustained unresponsiveness to peanut 12 weeks after stopping combination therapy.

Conditions
Peanut Allergy
Being tested
Tezepelumab, Peanut Oral Immunotherapy (OIT), Placebo for Tezepelumab
Keywords
Tezepelumab, Peanut, Oral Immunotherapy
Medical subject headings
Peanut Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TezepelumabBiological

    Monotherapy Period: Participants randomized to tezepelumab will receive two subcutaneous (SQ) injections of tezepelumab 210 mg during the monotherapy period.

    Combination Therapy Period: Participants randomized to Tezepelumab will continue to receive Tezepelumab 210 mg every 4 weeks.

    Withdrawal Period: Participants will stop receiving Tezepelumab injections.

  • Peanut Oral Immunotherapy (OIT)Drug

    Monotherapy Period: Not Applicable. Combination Therapy Period: During combination therapy period, each participant will start peanut OIT. Participants will start on a minimum of 0.1 mg peanut OIT, with starting dose depending on last tolerated dose from screening double-blind placebo-controlled food challenge (DBPCFC) and build to a maximum of 6 mg peanut OIT on the initial dose escalation (IDE) day. Participants will return every 2 weeks for dose escalation to a goal maintenance dose of 2000 mg peanut protein.

    Withdrawal Period: Participants will stop peanut OIT.

  • Placebo for TezepelumabBiological

    Monotherapy Period: Participants randomized to placebo for tezepelumab will receive two subcutaneous (SQ) injections of placebo 210 mg during the monotherapy period.

    Combination Therapy Period: Participants randomized to placebo will continue to receive placebo for Tezepelumab every 4 weeks.

    Withdrawal Period: Participants will stop receiving placebo injections.

Study groups in NCT07015996
Study groupRoleWhat they receive
Tezepelumab plus Peanut Oral Immunotherapy (OIT) GroupExperimentalEligible participants will be randomized in a 1:1 fashion to receive Tezepelumab during the monotherapy period of the trial. Throughout the combination therapy period, which also includes an OIT build-up and maintenance period, participants will remain on tezepelumab 210 mg every 4 weeks until reaching the final period of the trial, the withdrawal period.
Receives: Biological: Tezepelumab; Drug: Peanut Oral Immunotherapy (OIT)
Placebo for Tezepelumab plus peanut Oral Immunotherapy (OIT) GroupPlacebo comparatorEligible participants will be randomized in a 1:1 fashion to receive placebo for Tezepelumab during the monotherapy period of the trial. Throughout the combination therapy period, which also includes an OIT build-up and maintenance period, participants will remain on placebo for tezepelumab every 4 weeks until reaching the final period of the trial, the withdrawal period.
Receives: Drug: Peanut Oral Immunotherapy (OIT); Biological: Placebo for Tezepelumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Consumption of a cumulative dose of 4000 mg of peanut protein without dose-limiting symptoms during the open Oral Food Challenge (OFC)

    The primary endpoint is sustained unresponsiveness to peanut 12 weeks after stopping combination therapy, as assessed by passing the open OFC to peanut at Week 76

    Measured: At week 76

Secondary outcomes (7)

  1. Highest single dose of peanut protein consumed without doselimiting symptoms during the open Oral Food Challenge (OFC)

    Measured: At week 64 and 76

  2. Consumption of a cumulative dose of 4000 mg of peanut protein without doselimiting symptoms during the open Oral Food Challenge (OFC)

    Measured: At week 64

  3. Highest cumulative dose of peanut protein consumed without dose limiting symptoms during the open Oral Food Challenge (OFC)

    Measured: At week 64 and 76

  4. An adverse event related to monotherapy

    Measured: During 8 weeks of therapy

  5. An adverse event related to combination therapy

    Measured: During 56 weeks of therapy

  6. An adverse event related to tezepelumab plus peanut Oral Immunotherapy (OIT) discontinuation

    Measured: 12 weeks after discontinuation of treatment

  7. An adverse event related to placebo plus peanut Oral Immunotherapy (OIT) discontinuation

    Measured: 12 weeks after discontinuation of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2025
  2. Study start27 Jul 2026
  3. Primary completionMay 2029 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07015996
Sponsor's protocol ID
DAIT ITN097AD
Acronym
ZENITH
Status last verified
Sep 2026
First submitted
3 Jun 2025
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.

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