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Tezepelumab in Allergic Rhinitis and Asthma Study (TEZARS)

NCT06189742 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-01-20

No results posted yet for this study

Summary

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.

Conditions

  • Asthma With Allergic Rhinitis

Interventions

BIOLOGICAL

Tezepelumab

Tezepelumab is a monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP).

Sponsors & Collaborators

  • Dr. Anne Ellis

    lead OTHER

Principal Investigators

  • Anne K Ellis, MD · Queen's University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-29
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06189742 on ClinicalTrials.gov