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Efficacy of Tezepelumab in Peanut Oral Immunotherapy (Zenith)

ZENITH is a clinical study testing whether peanut oral immunotherapy in combination with an experimental medication will help people allergic to peanut become less sensitive to peanuts and lower the risk of life threatening allergic reactions.

Age & Gender

  • 12 years ~ 55 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide), South Carolina, Virginia

What will be asked of you

Peanut allergic study participants between the ages of 12 and 55 years will be randomly assigned to one of two groups. Initially, one group will receive tezepelumab and the other will receive placebo. After 8 weeks, peanut OIT will be added to each group for a period of 56 weeks. Then, participants will stop taking tezepelumab/placebo and OIT for 12 weeks. Allery to peanut will be assessed three times by food challenge during the study: -At screening to assess peanut allergy -The end of the 56-week combination therapy period -Following the 12-week experimental drug withdrawal Throughout the study, blood, urine, and saliva samples will be collected, and skin prick testing will be conducted.

Incentives

Information provided upon request in consent form

In-person visits:
Approximately 30
Total length of participation:
About 18 months

Looking for Specific Volunteers

Able to participate:

  • Peanut Allergy

Not eligible if:

  • Use of any food immunotherapy in last 12 months
  • Allergy to Oat
  • Pregnant, planning a pregnancy during the study, or breastfeeding
  • Severe, uncontrolled asthma
  • Eosinophilic Esophagitis (EoE) at screening

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Visit Study Website

Primary Visit Location

Clinical and Translational Research Center (CTRC)
Burnett-Womack Building (UNC-Chapel Hill)
160 Dental Cir, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Edwin Kim
Pediatrics - Allergy Immunology and Rheumatology

Study Type

Clinical or Medical
Interventional

Study Topics

Allergy

IRB Number

25-0630

ClinicalTrials.gov

NCT07015996

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