Asthma With Allergic RhinitisPhase 2TEZARSNCT06189742
Tezepelumab in Allergic Rhinitis and Asthma Study (TEZARS)
A Phase 2 study testing Tezepelumab in people with Asthma With Allergic Rhinitis, run by Dr. Anne Ellis at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma With Allergic Rhinitis
- What is being tested?
- Tezepelumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jan 2024to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For inclusion in the study, all participants should fulfil the following criteria based on local regulations:
- Must be able and willing to provide written informed consent.
- Must be willing and able to comply with the study requirements.
- People between the ages of 18 and 65.
- Body weight greater than 45 kg.
- A person of childbearing potential must be either abstinent or using a medically acceptable method of birth control (see Section 3.5) and produce a negative urine pregnancy test at the screening visit and again at each treatment visit.
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- For inclusion in the study, non-allergic participants should fulfil the following additional criteria based on local regulations:
- Negative skin prick test to all relevant aeroallergen at screening with a wheal diameter no larger than that produced by the negative control.
- Specific IgE levels to a relevant allergen are undetectable.
- Negative screening Nasal Allergen Challenge, defined by a TNSS response of ≤ 3 (on a 12-point scale) and a decrease in PNIF of ≤ 30% after 10 minutes in response to a nasal application of a relevant aeroallergen extract.
- For inclusion in the study, allergic participants should fulfil the following additional criteria based on local regulations:
- A minimum 2-year documented history of rhinoconjunctivitis symptoms to a relevant aeroallergen.
- Positive skin prick test to a relevant aeroallergen at screening (matching the history in IC2) with a wheal diameter at least 5 mm larger than that produced by the negative control.
- A minimum 2-year documented history of asthma, controlled with either moderate or high dose inhaled corticosteroids with or without another controller medication (long-acting beta-agonists and/or montelukast and/or a long-acting muscarinic antagonist.
- Positive screening Nasal Allergen Challenge, defined by a TNSS response of ≥ 7 (on a 12-point scale) and a decrease in PNIF of ≥ 50% after 10 minutes in response to a nasal application of a relevant aeroallergen extract.
Who cannot join
- Participants should not enter the study if any of the following exclusion criteria are fulfilled:
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
- Is unlikely to cooperate with the requirements of the study including having the ability to communicate with the investigator appropriately.
- Inability to attend study visits or adhere to the study protocol, in the judgment of the principal investigator.
- Previous enrolment in the present study.
- Participation in another clinical study with an investigational product during the last 30 days.
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- Known hypersensitivity to the investigational product.
- Currently uses or is expected to use any of the prohibited medications or other treatments as listed in Section 7.7.
- An upper respiratory tract infection within 14 days of the NAC portion of the screening visit or baseline NAC visit.
- History of immunological disorders or other diseases (including, but not limited to malignancy, cardiovascular, gastrointestinal, hepatic, renal, haematological, neurological, endocrine or pulmonary disease) that in the opinion of the investigator may pose additional risk factors for participation. Participants with basal cell carcinoma or squamous cell carcinoma that has been excised in the past 5 years may still participate in the study.
- Nasal conditions that, according to the opinion of the investigator, may affect the outcome of the study, i.e. nasal septal perforation, current nasal polyps, other nasal malformations or history of frequent nosebleeds.
- A known history of positive test results for Hepatitis B, Hepatitis C, HIV or tuberculosis other than what would be anticipated following vaccination.
- Participant has a known history of current or previous parasitic infection.
- Participant that is pregnant, lactating or actively trying to become pregnant.
- Participant with a clinically relevant abnormality on physical examination.
- Participant is unable to communicate or to understand the requirements of the study, which would impair communication between the participant and the investigator.
- Significant history of alcohol or drug abuse, in the judgment of the investigator.
- Serious asthma exacerbation requiring a hospital visit and/ or treatment with oral steroids within 4 weeks prior to screening.
- FEV1 < 40 % predicted at screening.
- Pre-NAC TNSS > 4 at the screening and baseline NAC visit.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Kingston Health Sciences Centre- Kingston General Hospital
Kingston, Ontario, K7L 2V7
About this study
Official title: Tezepelumab in the Treatment of Co-morbid Allergic Rhinitis and Allergic Asthma Study (TEZARS) - An Open-Label Exploratory Mechanistic Pilot Study to Evaluate Tezepelumab Efficacy in Asthma and Allergic Rhinitis
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?
Read more
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.
Read the detailed description
Tezepelumab is a novel monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP), a molecule implicated in allergic disease. The purpose of this open-label, unblinded, exploratory mechanistic pilot study will be to evaluate the efficacy of tezepelumab (1 subcutaneous injection of 210mg given once every 4 weeks) in participants with moderate to severe allergic asthma and concomitant seasonal and perennial AR (SAR and/or PAR) over 12 months.
The tezepelumab in allergic rhinitis and asthma study (TEZARS) is a single-centre study. The trial will enrol 14 non-pregnant/non-lactating female and/or male comorbid allergic rhinitis (AR) and allergic asthma participants ages 18 to 65 years old from the Kingston, Frontenac, Lennox and Addington regions. An additional 5 non-allergic participants will be enrolled to participate in the baseline Nasal Allergen Challenge (NAC) visit and then will exit the study. Comorbid AR and allergic asthma participants attend the baseline NAC, then receive one dose of tezepelumab every 1 month for 12 months. A 6-month post-treatment follow-up NAC will be conducted one month following the sixth dose. A 12-month post-treatment follow-up NAC will be conducted two weeks following the twelfth dose. At each NAC visit, symptom scores and quality of life questionnaires, in addition to nasal fluid and blood samples will be collected at various time points.
The investigators hypothesize that tezepelumab will improve AR-related outcomes (TNSS; Peak Nasal Inspiratory Flow, PNIF; Rhinitis Control Assessment Test, RCAT) that are stimulated by NAC with seasonal and perennial allergens in our study population. Secondarily, the investigators hypothesize tezepelumab will decrease the release of allergic mediators (i.e., IL-1b, IL-3, IL-4, IL-5, IL-6, IL-8, IL-9 IL-10, IL-13, IL-18, MCP-1, TNFα, RANTES, eotaxin, tryptase, chymase) and alarmins (i.e., TSLP, IL-25, and IL-33) in the nose following NAC. A decrease in the gene expression of TSLP and mast cell mediators (tryptase and chymase) is also anticipated. Furthermore, the number of both nasal and peripheral eosinophils and total and specific immunoglobulin E (IgE) following NAC will decline after tezepelumab treatment. Five non-atopic controls will undergo baseline NAC to confirm the reliability of allergic mediator and alarmin methodologies. The investigators also hypothesize asthma-related outcomes (spirometry; Fractional Exhaled Nitric Oxide, FeNO; Asthma Control Questionnaire 5, ACQ5) will improve following treatment with tezepelumab. Finally, the NAC protocol in an asthmatic population will be assessed.
- Conditions
- Asthma With Allergic Rhinitis
- Being tested
- Tezepelumab
- Keywords
- Allergy, Allergic Rhinitis, Allergic Asthma, Allergic Asthma and Allergic Rhinitis, Tezepelumab, Seasonal allergies, Perennial allergies, Intermitent allergies, Persistant allergies
- Medical subject headings
- Hypersensitivity, Rhinitis, Allergic, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TezepelumabBiological
Also called TEZSPIRE, tezepelumab-ekko
Tezepelumab is a monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP).
| Study group | Role | What they receive |
|---|---|---|
| Non-allergic Participants | No intervention | Not described |
| Allergic Participants | Experimental | Not described Receives: Biological: Tezepelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score (TNSS)
To evaluate the effect of treatment with tezepelumab (210mg subcutaneous injection, once every 4 weeks for 12 doses) on TNSS (where a score of 0 indicates no nasal symptoms and 12 indicates the worst nasal symptoms) and 12 elicited by Nasal Allergen Challenge compared to baseline in a population with comorbid allergic rhinitis and allergic asthma.
Measured: Baseline, 6 months, and 12 months
Secondary outcomes (15)
Peak Nasal Inspiratory Flow (PNIF)
To evaluate the effect of treatment with tezepelumab (210mg subcutaneous injection, once every 4 weeks for 12 doses) on PNIF elicited by Nasal Allergen Challenge compared to baseline in a population with comorbid allergic rhinitis and allergic asthma.
Measured: Baseline, 6 months, and 12 months
Total Rhinoconjunctivitis Symptom Score (TRSS)
To evaluate the effect of treatment with tezepelumab (210mg subcutaneous injection, once every 4 weeks for 12 doses) on TRSS (where a score of 0 indicates no rhinoconjunctivitis symptoms and a score of 24 indicates the most rhinoconjunctivitis symptoms) elicited by Nasal Allergen Challenge compared to baseline in a population with comorbid allergic rhinitis and allergic asthma.
Measured: Baseline, 6 months, and 12 months
Total Ocular Symptom Score (TOSS)
To evaluate the effect of treatment with tezepelumab (210mg subcutaneous injection, once every 4 weeks for 12 doses) on TOSS (where a score of 0 indicates no ocular symptoms and a score of 9 indicates the most ocular symptoms) elicited by Nasal Allergen Challenge compared to baseline in a population with comorbid allergic rhinitis and allergic asthma.
Measured: Baseline, 6 months, and 12 months
Rhinitis Control Assessment Test (RCAT).
To evaluate the effect of treatment with tezepelumab (210mg subcutaneous injection, once every 4 weeks for 12 doses) on RCAT elicited by Nasal Allergen Challenge compared to baseline in a population with comorbid allergic rhinitis and allergic asthma. Six questions are ranked, and scores range between 1 (severely uncontrolled) and 5 (totally controlled).
Measured: Each month for 12 months
Concentration of specific and total immunoglobulin E from nasal fluids.
To evaluate the effect of treatment with tezepelumab on nasal and peripheral allergic biomarkers pre- and post-Nasal Allergen Challenge.
Measured: Baseline, 6 months, and 12 months
Concentration of tryptase from nasal fluids.
To evaluate the effect of treatment with tezepelumab on nasal and peripheral allergic biomarkers pre- and post-Nasal Allergen Challenge.
Measured: Baseline, 6 months, and 12 months
Concentration of chymase from nasal fluids.
To evaluate the effect of treatment with tezepelumab on nasal and peripheral allergic biomarkers pre- and post-Nasal Allergen Challenge.
Measured: Baseline, 6 months, and 12 months
Concentration of alarmins (TSLP, IL-33, IL-25) and type 2 cytokines (IL-4, Il-5, IL-13, etc.) from nasal fluids.
To evaluate the effect of treatment with tezepelumab on nasal and peripheral allergic biomarkers pre- and post-Nasal Allergen Challenge.
Measured: Baseline, 6 months, and 12 months
Concentration of specific and total immunoglobulin E from serum.
To evaluate the effect of treatment with tezepelumab on nasal and peripheral allergic biomarkers pre- and post-Nasal Allergen Challenge.
Measured: Baseline, 6 months, and 12 months
Concentration of tryptase from serum
To evaluate the effect of treatment with tezepelumab on nasal and peripheral allergic biomarkers pre- and post-Nasal Allergen Challenge.
Measured: Baseline, 6 months, and 12 months
White blood cell count from whole blood.
To evaluate the effect of treatment with tezepelumab on nasal and peripheral allergic biomarkers pre- and post-Nasal Allergen Challenge.
Measured: Baseline, 6 months, and 12 months
Forced Expiratory Volume for 1 second (FEV1)
To evaluate the effect of treatment with tezepelumab on asthma control following Nasal Allergen Challenge.
Measured: Each month for 12 months
Peak Expiratory Flow Rate (PEFR)
To evaluate the effect of treatment with tezepelumab on asthma control following Nasal Allergen Challenge.
Measured: Each month for 12 months
Fractional Exhaled Nitric Oxide (FeNO)
To evaluate the effect of treatment with tezepelumab on asthma control following Nasal Allergen Challenge.
Measured: Baseline, 6 months, and 12 months
Asthma Control Questionnaire 5 (ACQ5).
To evaluate the effect of treatment with tezepelumab on asthma control following Nasal Allergen Challenge. Five questions are ranked, and scores range between 0 (totally controlled) and 6 (severely uncontrolled).
Measured: Each month for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start29 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma With Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Anne Ellis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Anne Ellis, Queen's University
- Investigators
- Anne K Ellis, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189742
- Sponsor's protocol ID
- TEZARS-001
- Acronym
- TEZARS
- Status last verified
- Jan 2026
- First submitted
- 28 Nov 2023
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tezepelumab in the Treatment of Co-morbid Allergic Rhinitis and Allergic Asthma Study (TEZARS) - An Open-Label Exploratory Mechanistic Pilot Study to Evaluate Tezepelumab Efficacy in Asthma and Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT06189742
- Acronym / sponsor ID
- TEZARS / TEZARS-001
- Conditions
- Asthma With Allergic Rhinitis
- Keywords
- Allergy, Allergic Rhinitis, Allergic Asthma, Allergic Asthma and Allergic Rhinitis, Tezepelumab, Seasonal allergies, Perennial allergies, Intermitent allergies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Dr. Anne EllisUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tezepelumab is a novel monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP), a molecule implicated in allergic disease. The purpose of this open-label, unblinded, exploratory mechanistic pilot study will be to evaluate the efficacy of tezepelumab (1 subcutaneous injection of 210mg given once every 4 weeks) in participants with moderate to severe allergic asthma and concomitant seasonal and perennial AR (SAR and/or PAR) over 12 months.
The tezepelumab in allergic rhinitis and asthma study (TEZARS) is a single-centre study. The trial will enrol 14 non-pregnant/non-lactating female and/or male comorbid allergic rhinitis (AR) and allergic asthma participants ages 18 to 65 years old from the Kingston, Frontenac, Lennox and Addington regions. An additional 5 non-allergic participants will be enrolled to participate in the baseline Nasal Allergen Challenge (NAC) visit and then will exit the study. Comorbid AR and allergic asthma participants attend the baseline NAC, then receive one dose of tezepelumab every 1 month for 12 months. A 6-month post-treatment follow-up NAC will be conducted one month following the sixth dose. A 12-month post-treatment follow-up NAC will be conducted two weeks following the twelfth dose. At each NAC visit, symptom scores and quality of life questionnaires, in addition to nasal fluid and blood samples will be collected at various time points.
The investigators hypothesize that tezepelumab will improve AR-related outcomes (TNSS; Peak Nasal Inspiratory Flow, PNIF; Rhinitis Control Assessment Test, RCAT) that are stimulated by NAC with seasonal and perennial allergens in our study population. Secondarily, the investigators hypothesize tezepelumab will decrease the release of allergic mediators (i.e., IL-1b, IL-3, IL-4, IL-5, IL-6, IL-8, IL-9 IL-10, IL-13, IL-18, MCP-1, TNFα, RANTES, eotaxin, tryptase, chymase) and alarmins (i.e., TSLP, IL-25, and IL-33) in the nose following NAC. A decrease in the gene expression of TSLP and mast cell mediators (tryptase and chymase) is also anticipated. Furthermore, the number of both nasal and peripheral eosinophils and total and specific immunoglobulin E (IgE) following NAC will decline after tezepelumab treatment. Five non-atopic controls will undergo baseline NAC to confirm the reliability of allergic mediator and alarmin methodologies. The investigators also hypothesize asthma-related outcomes (spirometry; Fractional Exhaled Nitric Oxide, FeNO; Asthma Control Questionnaire 5, ACQ5) will improve following treatment with tezepelumab. Finally, the NAC protocol in an asthmatic population will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-allergic Participants | No intervention | – |
| Allergic Participants | Experimental | Biological: Tezepelumab |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- For inclusion in the study, all participants should fulfil the following criteria based on local regulations:
- Must be able and willing to provide written informed consent.
- Must be willing and able to comply with the study requirements.
- People between the ages of 18 and 65.
- Body weight greater than 45 kg.
Key exclusion criteria (20 listed)
- Participants should not enter the study if any of the following exclusion criteria are fulfilled:
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
- Is unlikely to cooperate with the requirements of the study including having the ability to communicate with the investigator appropriately.
- Inability to attend study visits or adhere to the study protocol, in the judgment of the principal investigator.
- Previous enrolment in the present study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TezepelumabAlso: TEZSPIRE, tezepelumab-ekkoTezepelumab is a monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP). | Biological | Allergic Participants |
Primary outcome
Total Nasal Symptom Score (TNSS)
Time frame: Baseline, 6 months, and 12 months
To evaluate the effect of treatment with tezepelumab (210mg subcutaneous injection, once every 4 weeks for 12 doses) on TNSS (where a score of 0 indicates no nasal symptoms and 12 indicates the worst nasal symptoms) and 12 elicited by Nasal Allergen Challenge compared to baseline in a population with comorbid allergic rhinitis and allergic asthma.
15 secondary outcomes
Peak Nasal Inspiratory Flow (PNIF)
Time frame: Baseline, 6 months, and 12 months
Total Rhinoconjunctivitis Symptom Score (TRSS)
Time frame: Baseline, 6 months, and 12 months
Total Ocular Symptom Score (TOSS)
Time frame: Baseline, 6 months, and 12 months
Rhinitis Control Assessment Test (RCAT).
Time frame: Each month for 12 months
Concentration of specific and total immunoglobulin E from nasal fluids.
Time frame: Baseline, 6 months, and 12 months
Concentration of tryptase from nasal fluids.
Time frame: Baseline, 6 months, and 12 months
Concentration of chymase from nasal fluids.
Time frame: Baseline, 6 months, and 12 months
Concentration of alarmins (TSLP, IL-33, IL-25) and type 2 cytokines (IL-4, Il-5, IL-13, etc.) from nasal fluids.
Time frame: Baseline, 6 months, and 12 months
Concentration of specific and total immunoglobulin E from serum.
Time frame: Baseline, 6 months, and 12 months
Concentration of tryptase from serum
Time frame: Baseline, 6 months, and 12 months
White blood cell count from whole blood.
Time frame: Baseline, 6 months, and 12 months
Forced Expiratory Volume for 1 second (FEV1)
Time frame: Each month for 12 months
Peak Expiratory Flow Rate (PEFR)
Time frame: Each month for 12 months
Fractional Exhaled Nitric Oxide (FeNO)
Time frame: Baseline, 6 months, and 12 months
Asthma Control Questionnaire 5 (ACQ5).
Time frame: Each month for 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne K Ellis, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tezepelumab in people with Asthma With Allergic Rhinitis, run by Dr. Anne Ellis at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Nasal Symptom Score (TNSS) (time frame: Baseline, 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.