NCT07015996 · National Institute of Allergy and Infectious Diseases (NIAID)
Efficacy of Tezepelumab in Peanut Oral Immunotherapy
(ZENITH)
What this study is about
The proposed study is a proof-of-concept Phase 2, where neither patients nor doctors know which treatment is given, randomly assigned compared against an inactive treatment clinical trial evaluating the safety and effectiveness of tezepelumab and peanut taken by mouth Immunotherapy (OIT) for the treatment of peanut allergy.
View original scientific description
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.
Interventions
BIOLOGICAL
Tezepelumab
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.
DRUG
Peanut Oral Immunotherapy (OIT)
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.
BIOLOGICAL
Placebo for Tezepelumab
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.
Primary outcome measures
Consumption of a cumulative dose of 4000 mg of peanut protein without dose-limiting symptoms during the open Oral Food Challenge (OFC)
Time frame: At week 76
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. 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 milligram cumulative dose) during the screening Double-Blind Placebo-Controlled Food Challenge (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 kilounit per liter by ImmunoCAP (TM) 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 du
Where
- Little Rock, Arkansas
- Los Angeles, California
- Baltimore, Maryland
- Boston, Massachusetts
- Ann Arbor, Michigan
- New York, New York
- Chapel Hill, North Carolina
- Cincinnati, Ohio
- Dallas, Texas
Collaborators
Immune Tolerance Network (ITN), PPD Development, LP, Rho Federal Systems Division, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations