J45 NULL NULL
Conditions
Interventions
Tezepelumab 210mg, SC, Q4W -
Placebo, SC, Q4W
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent form. Documented physician-diagnosed asthma for at least 12 months prior to Visit 1. Morning pre-BD FEV1 must be 500 µg fluticasone propionate dry powder formulation or equivalents) as per GINA guideline (GINA 2021) for at least 12 months prior to Visit 1. Additional maintenance asthma controller medications are allowed according to standard practice of care ie, leukotriene receptor antagonists (LTRAs), theophylline, long-acting muscarinic antagonists (LAMAs), and chromones. The use of these medications must be documented for at least 3 months prior to Visit 1 Blood eosinophils at Visit 1 =150 cells/µL(=0.15 x109/L or =0.15 x103/µl) or documented EOS = 300 cells/µL (=0.3 x109/L or =0.3 x103/µl) within 12 months prior to Visit 1. Participants must have received physician-prescribed LABA and high dose ICS (total daily dose > 500µg fluticasone propionate dry powder formulation or equivalent) for at least 3 months prior to Visit 1. The ICS and LABA can be parts of a combination product or given by separate inhalers. (a) Equivalent ICS doses as detailed in Appendix G Body weight = 40 kg at Visit 1. Male or female. All women of childbearing potential must have a negative serum pregnancy test results at Visit 1 and a negative urine pregnancy test at randomisation. Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative. Minimum 10 days compliance with both the morning and evening daily diary completion and PEF measurements during the 14 days prior to Visit 2. A compliant day requires completion of evening measurements and subsequent morning measurements such that an ASD daily score can be calculated. Minimum 10 days compliance with OCS, ICS, LABA and other asthma controller medications as c
Exclusion criteria
Exclusion criteria: Participant randomised in other ongoing or previous tezepelumab studies. Involvement in the planning and/or conduct of the study (applies to AstraZeneca staff and/or site staff), or participants employed by or relatives of the employees of the site or sponsor. Any clinically meaningful abnormal findings in physical examination, vital signs, electrocardiogram (ECG), haematology, clinical chemistry, or urinalysis during the run-in period, which in the opinion of the investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant's ability to complete entire duration of the study. Evidence of active liver disease, including jaundice or aspartate transaminase, alanine transaminase, or alkaline phosphatase beyond twice the upper limit of normal (ULN), at Visit 1. Women who are currently pregnant (confirmed with positive pregnancy test) or breastfeeding or lactating. History of cancer: (a) Participants who have had basal cell carcinoma, localised squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit 1. (b) Participants who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1. Asthma exacerbation, requiring use of systemic corticosteroids or increase in the maintenance dose of OCS finalised within 30 days prior to Visit 1. Clinically significant infection, including upper or lower respiratory tract infection (URTI and LRTI, respectively), requiring treatment with systemic antibiotics or antiviral medications finalised < 2 weeks before Visit 1 or during the run-in period. Participants with evidence of active COVID-19 infection during run-in period and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The categories for percent change from baseline in daily OCS dose are defined as: 1.= 90% to = 100% reduction 2.= 75% to 0% to < 50% reduction 5.no change or any increase. NAME OF THE RESULT: Categorised percent reduction from baseline in the daily maintenance OCS dose at Week 28 whilst maintaining asthma control. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: The cumulative odds ratio at Week 28 (tezepelumab/placebo). | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of anti-drug antibodies (ADAs) at Week 0, 12, 28, and 40 NAME OF THE RESULT: The immunogenicity of tezepelumab PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Week 0, 12, 28, and 40 ;The categories for percent change from baseline in daily OCS dose are defined as: 1. = 90% to = 100% reduction 2. = 75% to 0% to < 50% reduction 5. no change or any increase. NAME OF THE RESULT: Categorised percent reduction from baseline in the daily maintenance OCS dose at Week 28 whilst maintaining asthma control. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: The cumulative odds ratio at Week 28 (tezepelumab/placebo). ;forced expiratory volume in 1 second (pre-BD FEV1) at Week 28. NAME OF THE RESULT: Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV1) at Week 28. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: The difference in means at Week 28 (tezepelumab – placebo). ;• Proportion of participants with 100% reduction from baseline in daily maintenance OCS dose at Week 28 • Proportion of participants with daily maintenance OCS dose = 5 mg at Week 28 • Proportion of participants with = 50% reduction from baseline in daily maintenance OCS dose at Week 28 NAME OF THE RESULT: The effect of tezepelumab compared with placebo on the daily dose of maintenance OCS PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Week 28 ;• Annualised asthma exacerbation rate (AAER) over 28 weeks | — |
Countries
Brazil, Canada, Chile, Colombia, Czech Republic, Korea South, Mexico, Peru, Poland, Thailand, Turkey, United States
Contacts
Public ContactKelly Vasquez
ASTRAZENECA PERU S.A.
Outcome results
None listed