Efficacy of Tezepelumab in Peanut Oral Immunotherapy

NCT07015996 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: DAIT ITN097AD
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 10

Brief 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. 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

Keywords

Tezepelumab; Peanut; Oral Immunotherapy

Outcome Measures

Primary Outcomes (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

  At week 76

Secondary Outcomes (7)

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

  At week 64 and 76

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

  At week 64

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

  At week 64 and 76

• An adverse event related to monotherapy

  During 8 weeks of therapy

• An adverse event related to combination therapy

  During 56 weeks of therapy

Study Arms (2)

Tezepelumab plus Peanut Oral Immunotherapy (OIT) Group

EXPERIMENTAL

Eligible 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.

Biological: Tezepelumab; Drug: Peanut Oral Immunotherapy (OIT)

Placebo for Tezepelumab plus peanut Oral Immunotherapy (OIT) Group

PLACEBO COMPARATOR

Eligible 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.

Drug: Peanut Oral Immunotherapy (OIT); Biological: Placebo for Tezepelumab

Interventions

Tezepelumab BIOLOGICAL

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.

Tezepelumab plus Peanut Oral Immunotherapy (OIT) Group

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 Tezepelumab plus peanut Oral Immunotherapy (OIT) Group; Tezepelumab plus Peanut Oral Immunotherapy (OIT) Group

Placebo for Tezepelumab BIOLOGICAL

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.

Placebo for Tezepelumab plus peanut Oral Immunotherapy (OIT) Group

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participant and/or parent/legal guardian must be able to understand and provide informed consent (parental permission and informed assent of minor, if applicable)
• 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 milligram cumulative dose) during the screening Double-Blind Placebo-Controlled Food Challenge (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 kilounit per liter by ImmunoCAP (TM) testing, or
• 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

You may not qualify if:

• 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
• 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 1 year before 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, where, in the opinion of the site investigator, participation in the trial would pose a risk from participation in 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, where, 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 informed consent
• Current known helminth infection
• Positive QuantiFERON - TB Gold test or TB Gold Plus, or T-SPOT(R) 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:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Immune Tolerance Network (ITN): collaborator
• PPD Development, LP: collaborator
• Rho Federal Systems Division, Inc.: collaborator

Study Sites (10)

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

Little Rock, Arkansas, 72202, United States

Location

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

Los Angeles, California, 90095, United States

Location

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

Baltimore, Maryland, 21287, United States

Location

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

Boston, Massachusetts, 02114, United States

Location

Boston Children's Hospital: Allergy and Asthma Program

Boston, Massachusetts, 02115, United States

Location

The University of Michigan: Division of Allergy and Clinical Immunology

Ann Arbor, Michigan, 48105, United States

Location

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

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

Location

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

Chapel Hill, North Carolina, 27599, United States

Location

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

Cincinnati, Ohio, 45229, United States

Location

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

Dallas, Texas, 75390-9063, United States

Location

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID)
• Division of Allergy, Immunology, and Transplantation (DAIT)

MeSH Terms

Conditions

Peanut Hypersensitivity

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Edwin H Kim, M.D., M.S.

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

  STUDY CHAIR

• Sarita Patil, M.D.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): September 16, 2028
• Study Completion (Estimated): September 16, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: On average, within 24 months after database lock for the trial.
• Access Criteria: Open access.

Locations

US (10)