Study in Patients 12-80yrs of Age With Severe Asthma

Do you suffer from severe Asthma?

This clinical research study is looking at the safety and effectiveness of a medication for people with severe asthma. Asthma is a condition in which your airways narrow and swell and may produce extra mucus. This can make breathing difficult and trigger coughing, a whistling sound (wheezing) when you breathe out, and shortness of breath.

The objective of this study is to assess the potential for tezepelumab-treated patients (administrated through injection) to reduce maintenance therapy without loss of asthma control in adolescents and adults with severe asthma..

Study details include:

1. The study duration will be up to 72 weeks.
2. The treatment duration will be up to 68 weeks.
3. The visit frequency will be once every 4 weeks.

Would you like to contribute to medical research?

As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow-up of your asthma to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others with asthma, and whether it will be made widely available to all Canadians with asthma. Study volunteers are an important part of moving medical care forward.

You may qualify to participate in this study if you:

• Provide signed and dated written ICF prior to any mandatory study-specific procedures, sampling, and analyses for patients who are at or over the age of majority (as per local law). For patients who are less than the age of majority, in addition to providing their informed consent, the patients’ legally authorized representative must also provide their informed assent.
• Are 12 to 80 years of age inclusive, at the time of signing the ICF.
• Have a documented medical record history for at least 12 months prior to Visit 1.
• Have documented, physician-diagnosed severe asthma within 10 years prior to Visit 1 (ie, severe asthma was not diagnosed more than 10 years prior) consisting of any of the following:

1. FEV1 > 12% reversibility, OR
2. Evidence of airflow variability (to show that lung function is altered over time): FEV1 ≥ 400 mL variability over time, OR
3. Challenge tests that are positive on one of the below:

• • (i) Methacholine – PD20 ≤ 8 mg/mL
  • (ii) Mannitol – PD15 15% drop on FEV1 out of dose < than 635 mg of inhaled mannitol
  • (iii) Exercise – 10% fall of FEV1
• Have a history of physician-diagnosed asthma that requires continuous treatment with high-dose ICS (as defined by GINA or highest approved dose per posology per country) plus a LABA for at least 6 months prior to Visit 1 (Appendix I). The ICS and LABA can be contained within a combination product or given by separate inhalers.Note: Additional maintenance asthma controller medications (eg, LTRAs, tiotropium, cromone, theophylline) are allowed.
• Pre-brochodilator FEV1 > 60% predicted and evidence of FEV1 reversibility of > 12% within 6 months prior to screening or at screening. Patients with normal lung function (FEV1 > 80%) need evidence of airflow variability as per inclusion criterion 4.
• Documented history of at least one asthma exacerbation requiring OCS bursts or requiring hospitalization within 12 months prior to Visit 1. An asthma exacerbation will be defined as a worsening of asthma symptoms that leads to any of the following:
  1. A temporary bolus/burst of systemic corticosteroids for at least 3 consecutive days to treat symptoms of asthma worsening; a single depo-injectable dose of corticosteroids will be considered equivalent to a 3-day bolus/burst of systemic corticosteroids
  2. Or, an ER visit (defined as evaluation and treatment for < 24 hours in ER) due to asthma that required systemic corticosteroids (as per above)
  3. Or, an in-patient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥ 24 hours).

You may not qualify to participate if you:

• Have any clinically important pulmonary disease other than asthma (eg, active lung infection, chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or pulmonary or systemic diseases, other than asthma, that are associated with elevated peripheral EOS counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).
• Have any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
  • Affect the safety of the patient throughout the study
  • Influence the findings of the study or the interpretation
  • Impede the patient’s ability to complete the entire duration of study.
• Have a helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy.
• Are a current smoker or patient with smoking history ≥ 10 pack-years and patients using vaping products, including electronic cigarettes. Former smokers with a smoking history of < 10 pack-years and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible.
• Have a history of chronic alcohol or drug abuse within 12 months prior to Visit 1.
• Have tuberculosis requiring treatment within the 12 months prior to Visit 1.
• Have a history of known immunodeficiency disorder including a positive human immunodeficiency virus test at Visit 1, or the patient taking antiretroviral medications as determined by medical history and/or patient’s verbal report.
• Have had major surgery within 8 weeks prior to Visit 1 or planned surgical procedures requiring general anaesthesia or inpatient status for > 1 day during the conduct of the study.
• Show evidence of COVID-19 within 4 weeks prior to screening or ongoing clinically significant COVID-19 sequelae.
• Have received any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to Visit 1 or receipt of any investigational nonbiologic agent within 30 days or 5 half-lives (whichever is longest) prior to Visit 1.
• Are an OCS-dependent patient (received chronic OCS therapy [prednisone ≥ 5 mg/day or equivalent]) for at least 3 months preceding Visit 1.
• Use maintenance corticosteroids for any reason.
• Have been treated with systemic immunosuppressive/immunomodulating drugs (eg, methotrexate, cyclosporine, etc.), except for OCS used in the treatment of asthma/asthma exacerbations, within the last 12 weeks or 5 half-lives (whichever is longer) prior to Visit 1.
• Have received immunoglobulin or blood products within 30 days prior to Visit 1.
• Have received live attenuated vaccines 30 days prior to the date of Visit 1 and during the study.
• Have been treated with bronchial thermoplasty in the last 12 months prior to Visit 1.
• Have a known history of sensitivity to any component of the tezepelumab formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
• Have a history of anaphylaxis or documented immune complex disease (Type III hypersensitivity reactions) following any biologic therapy.
• Are enrolled in another clinical study involving an IMP.
• Have any clinically meaningful abnormal finding in physical examination, haematology, clinical chemistry at Visit 1 which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient’s ability to complete the entire duration of the study.
• Show evidence of active liver disease, including jaundice or AST, ALT, or ALP > 2 times the ULN at Visit 1.
• Have a positive hepatitis B surface antigen, hepatitis C virus antibody serology at screening, or a positive medical history for hepatitis B or C. Patients with a history of hepatitis B vaccination without a history of hepatitis B are allowed to participate.

There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.