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? 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.
‣ 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.
• 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.