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Tezepelumab in Allergic Rhinitis and Asthma Study (TEZARS)

Study acronym: TEZARS
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Notable Primary and study completion dates: Apr 30, 2026 to Dec 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v4
  2. Minor Site contact updatedv3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 31, 2024 to Jan 29, 2024
    • Secondary endpoints: 11 to 15
    • Site details revised
    v2
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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The goal of this clinical trial is to learn about how well tezepelumab (pronounced TEZ e PEL ue mab), a Health Canada-approved drug for severe asthma, works in participants with coexisting allergic asthma and allergic rhinitis (hayfever). The main questions it aims to answer are: * How well does the study drug work to reduce nasal symptoms following exposure to an allergen after 6 doses, and after 12 doses? * Does the study drug reduce chemicals found in the nose known to be involved in the allergic rhinitis response? Both allergic and non-allergic participants will be enrolled in the study. Non-allergic participants will: * Not be receiving the study drug. * Be exposed to allergen via the Nasal Allergen Challenge, which involves the administration of allergen extract directly to the nose. * Complete nasal symptom and quality of life questionnaires * Have nasal fluid and blood samples collected at various time points up to 24 hours following allergen exposure. * Visit the clinic 3 separate times: * At a screening visit to determine their eligibility to participate in the study * At the baseline Nasal Allergen Challenge visit * At the 24-hour post-Nasal Allergen Challenge follow-up visit Allergic participants will: * Receive one dose of tezepelumab every 1 month for 12 months. Tezepelumab will be administered as an injection into the fatty layer just beneath the skin on the stomach, arm, or thigh. * Be exposed to allergen via the Nasal Allergen Challenge, which involves the administration of allergen extract directly to the nose. * Complete nasal symptom and quality of life questionnaires * Have nasal fluid and blood samples collected at various time points up to 24 hours following allergen exposure. * Visit the clinic 17 separate times: * At a screening visit to determine their eligibility to participate in the study * At the baseline, 6-month, and 12-month Nasal Allergen Challenge visits * At each 24-hour post-Nasal Allergen Challenge follow-up visit * For each dose of the study drug The investigator will compare changes in nasal symptoms and allergic chemicals measured from nasal fluid and blood samples between non-allergic participants and allergic participants at baseline and at 6- and 12-months following the use of the study drug.
Trial Details
NCT Number NCT06189742
Lead Sponsor Dr. Anne Ellis
Conditions
(from sponsor)
Asthma With Allergic Rhinitis
Related terms Hypersensitivity, Rhinitis, Allergic, Rhinitis, Allergic, Seasonal
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov