Efficacy of Tezepelumab in Peanut Oral Immunotherapy (NCT07015996) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy of Tezepelumab in Peanut Oral Immunotherapy
United States62 participantsStarted 2026-06-15
Plain-language 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.
Who can participate
Age range12 Years – 55 Years
SexALL
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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)
✓. 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
Exclusion criteria
✕
What they're measuring
1
Consumption of a cumulative dose of 4000 mg of peanut protein without dose-limiting symptoms during the open Oral Food Challenge (OFC)
Timeframe: At week 76
Trial details
NCT IDNCT07015996
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. 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