Tezepelumab in Allergic Rhinitis and Asthma Study (TEZARS)

NCT06189742 | Active Not Recruiting Phase 2

• 1 other identifier: TEZARS-001
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Allergy; Allergic Rhinitis; Allergic Asthma; Allergic Asthma and Allergic Rhinitis; Tezepelumab; Seasonal allergies; Perennial allergies; Intermitent allergies; Persistant allergies

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6 months, and 12 months

Secondary Outcomes (15)

• Peak Nasal Inspiratory Flow (PNIF)

  Baseline, 6 months, and 12 months

• Total Rhinoconjunctivitis Symptom Score (TRSS)

  Baseline, 6 months, and 12 months

• Total Ocular Symptom Score (TOSS)

  Baseline, 6 months, and 12 months

• Rhinitis Control Assessment Test (RCAT).

  Each month for 12 months

• Concentration of specific and total immunoglobulin E from nasal fluids.

  Baseline, 6 months, and 12 months

Other Outcomes (3)

• Adverse reactions induced by Nasal Allergen Challenge

  Baseline, 6 months, and 12 months

• Asthma symptoms induced by Nasal Allergen Challenge (symptom scores).

  Baseline, 6 months, and 12 months

• Asthma symptoms induced by Nasal Allergen Challenge (spirometry).

  Baseline, 6 months, and 12 months

Study Arms (2)

Non-allergic Participants

NO INTERVENTION

Allergic Participants

EXPERIMENTAL

Biological: Tezepelumab

Interventions

Tezepelumab BIOLOGICAL

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

Also known as: TEZSPIRE, tezepelumab-ekko

Allergic Participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Dr. Anne Ellis: lead

Study Sites (1)

Kingston Health Sciences Centre- Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Hypersensitivity; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

Immune System Diseases; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate

Study Officials

• Anne K Ellis, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Medicine, School of Medicine, and Department of Biomedical and Molecular Sciences, Queen's University; Director, Allergy Research Unit/Environmental Exposure Unit, Kingston Health Sciences Centre, KGH site

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: January 3, 2024
• Study Start: January 29, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)