Efficacy of Tezepelumab in Peanut Oral Immunotherapy: A Double-Blind, Randomized, Placebo-Controlled Trial (ZENITH)

Study Description

The goal of this study is to test whether peanut oral immunotherapy in combination with an investigational medication will help people allergic to peanut become less sensitive to peanuts and lower the risk of life-threatening allergic reactions.

Study Eligibility

Inclusion Criteria

1. Parent or guardian must be able to understand and provide written informed consent and participant must be able to understand and provide assent (if applicable)
2. Age 12 to 55 years, Arkansas site 12-34 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 double-blinded placebo controlled food challenge (DBPCFC)
4. A negative challenge to the placebo (oat) during the Screening
5. Sensitization to peanut as evidenced by either one of the following:
   • positive sIgE to Ara h2 ≥ 0.35 kU/L by ImmunoCAPTM testing, OR
   • 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

Individuals who meet any of these criteria are not eligible for the study:

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

Contact Information

Recruitment Coordinator: Marissa Pilcher
501-364-3031, pilchermr@archildrens.org

Lead Study Nurse/Coordinator: Erin Thomas, RN
501-364-2325, thomases@archildrens.org

Lead Study Doctor/Principal Investigator: Stacie Jones, M.D.
501-364-1060, jonesstaciem@uams.edu