RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Tezepelumab for Peanut Allergy

The proposed study is a proof-of-concept Phase 2, neither you nor the study doctors know who gets the real treatment, randomly assigned compared with a dummy treatment clinical trial evaluating the safety and how well it works of tezepelumab and peanut Oral Immunotherapy (OIT) for the treatment of peanut allergy. Study participation is divided into 3 periods: (i) a this drug alone period comprised of injections of either Tezepelumab or dummy treatment (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.

Official registry: https://clinicaltrials.gov/study/NCT07015996 · National Institute of Allergy and Infectious Diseases (NIAID) · enrollment listed as 62

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Tezepelumab, Peanut Oral Immunotherapy (OIT), or Placebo for Tezepelumab. The registry lists allocation as randomized. The proposed study is a proof-of-concept Phase 2, neither you nor the study doctors know who gets the real treatment, randomly assigned compared with a dummy treatment clinical trial evaluating the safety and how well it works of tezepelumab and peanut Oral Immunotherapy (OIT) for the treatment of peanut allergy.

They plan to enroll about 62 people at 10 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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

Interventions: Tezepelumab, Peanut Oral Immunotherapy (OIT), Placebo for Tezepelumab

Primary outcome (registry wording): Consumption of a cumulative dose of 4000 mg of peanut protein without dose-limiting symptoms during the open Oral Food Challenge (OFC)

Who it is for (from inclusion criteria)

Ages 12 Years to 55 Years
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 dummy treatment (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
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

Who the registry excludes

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)

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

10 listed

Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology — Little Rock, Arkansas (recruiting)
University of California, Los Angeles: Department of Medicine, Division of Clinical Immunology and Allergy — Los Angeles, California (not_yet_recruiting)
Johns Hopkins Children's Center: Department of Allergy & Immunology — Baltimore, Maryland (recruiting)
Massachusetts General Hospital: Department of Medicine: Allergy & Clinical Immunology Unit — Boston, Massachusetts (recruiting)
Boston Children's Hospital: Allergy and Asthma Program — Boston, Massachusetts (not_yet_recruiting)
The University of Michigan: Division of Allergy and Clinical Immunology — Ann Arbor, Michigan (not_yet_recruiting)
Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology — New York, New York (recruiting)
North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology — Chapel Hill, North Carolina (recruiting)
Cincinnati Children's Hospital Medical Center: Division of Allergy and Immunology — Cincinnati, Ohio (recruiting)
University of Texas Southwestern Medical Center: Division of Allergy and Immunology — Dallas, Texas (not_yet_recruiting)

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FAQ about this NCT record

Is NCT07015996 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07015996?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07015996?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary