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Efficacy of Tezepelumab in Peanut Oral Immunotherapy

Study acronym: ZENITH
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Sep 16, 2028 → May 2029
See other at-risk trials from National Institute of Allergy and Infectious Diseases (NIAID)

Record History

  1. Primary and study completion pushed from Sep 16, 2028 to May 2029 Start date changed from estimate of Jul 15, 2026 to Jul 27, 2026 · Eligibility criteria expanded, about 42 words · Site details revised at 7 of 10 sites Show 3 more changesShow less
    • Start date changed from estimate of Jul 15, 2026 to Jul 27, 2026
    • Eligibility criteria expanded, about 42 words
    • Site details revised at 7 of 10 sites
  2. Recruitment opened Start date: Jun 15, 2026 to Jul 15, 2026 · Site details revised at 10 of 10 sitesv6 Show 2 more changesShow less
    • Start date: Jun 15, 2026 to Jul 15, 2026
    • Site details revised at 10 of 10 sites
  3. Eligibility criteria expanded, about 23 wordsv5 See this version in full on ClinicalTrials.gov ↗
  4. Start date: Feb 18, 2026 to Jun 15, 2026v4
  5. Start date: Sep 16, 2025 to Feb 18, 2026v3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07015996
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Immune Tolerance Network (ITN), PPD Development, LP, Rho Federal Systems Division, Inc.
Conditions Peanut Allergy
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov