Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 26.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant must be = 40 years of age and capable of giving signed informed consent. 2. Documented diagnosis of COPD for at least one year prior to enrolment. 3. Post BD FEV1/FVC 20% of predicted normal value. 4. Documented history of = 2 moderate or = 1 severe COPD exacerbations within 12 months prior to enrolment. 5. Documented optimized inhaled dual or triple therapy at a stable dose for at least 3 months prior to enrolment. 6. Smoking history of = 10 pack-years. 7. CAT total score =10, with each of the phlegm (sputum) and cough items = 2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 519 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 541
Exclusion criteria
Exclusion criteria: 1. Clinically important pulmonary disease other than COPD. 2. Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms. Radiological findings of pulmonary nodules suspicious for lung cancer, as per applicable guidances,without appropriate follow up prior to randomisation. Radiological findings suggestive of acute infection. 3. Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18. 4. Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment that could affect safety, study findings or participants ability to complete the study. 5. COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization. 6. Active significant infection within the 4 weeks prior to randomization, pneumonia within 6 weeks prior to randomization, or medical condition that predisposes the participant to infection. 7. Suspicion of, or confirmed, ongoing SARS-CoV-2 infection. 8. Significant COVID-19 illness within the 6 months prior to enrolment. 9. Unstable cardiovascular disorder. 10. Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure. 11. History of known immunodeficiency disorder, including a positive test for HIV-1 or HIV 2. 12. History of positive test or treatment for hepatitis B or hepatitis C (except for cured hepatitis C) 13. Evidence of active liver disease, including jaundice during screening. 14. Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than one year prior to enrolment. Suspected malignancy or undefined neoplasms. 15. Participants who have evidence of active TB. 16. Participants that have previously received tozorakimab.. 17. Any clinically significant abnormal findings in physical examination, vital signs, ECG, or laboratory testing during the screening period, which in the opinion of the investigator may put the participant at risk because of their participation in the study, or may influence the results of the study, or the participant’s ability to complete the entire duration of the study. 18. Active vaping of any products or using smoked marijuana within the 6 months prior to randomization and during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of 2 dose regimens of tozorakimab as add on to standard of care compared with standard of care plus placebo on the rate of moderate to severe exacerbations in former smokers.;Secondary Objective: 1. To evaluate the effect of 2 dose regimens of tozorakimab as add on to standard of care compared with standard of care plus placebo on: a) the rate of moderate to severe COPD exacerbations in former and current smokers b) change in pre-bronchodilator lung function c) respiratory symptoms d) respiratory health status/health related quality of life e) time to first moderate to severe COPD exacerbations f) severe COPD exacerbations g) COPD health status/health-related quality of life h) COPD-related healthcare resource utilization i) daily rescue medication use 2.To evaluate the pharmacokinetics and immunogenicity of 2 dose regimens of tozorakimab. 3. To assess the safety and tolerability of two dose regimen of tozorakimab as add on to standard of care compared with standard of care plus placebo.;Primary end point(s): Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.;Timepoint(s) of evaluation of this end point: Week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Annualized rate of moderate to severe COPD exacerbations in former or current smokers 2. Change from baseline in SGRQ total score in former smokers 3. Change from baseline in SGRQ total score in former or current smokers 4. Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former smokers 5. Change from baseline in pre-bronchodilator, pre dose trough FEV1 (mL) in former or current smokers 6. Change from baseline in E-RS:COPD total score in former smokers 7. Change from baseline in E-RS:COPD total score in former or current smokers 8. Time to first moderate to severe COPD exacerbation in former smokers 9. Time to first severe COPD exacerbation in former smokers 10. Annualized rate of severe COPD exacerbations in former smokers 11. Proportion of patients achieving MCID in SGRQ total score in former smokers 12. Proportion of patients achieving MCID in E-RS:COPD total score in former smokers 13. Change from baseline in CAT total score in former smokers 14. Proportion of participants achieving MCID in CAT score in former smokers 15. Proportion of participants having = 1 healthcare resource utilization type in former smokers 16. Annualized rate of healthcare resource utilization in former smokers 17. Change from baseline in rescue medication in former smokers 18. Trough serum concentrations of tozorakimab 19. Presence of anti-drug antibodies 20. Safety and tolerability;Timepoint(s) of evaluation of this end point: Over 52 weeks./At week 52 | — |
Countries
Argentina, Belgium, Bulgaria, Canada, Czechia, Czech Republic, Denmark, Finland, Hungary, India, Japan, Korea, Democratic People's Republic of, Mexico, Netherlands, Norway, Portugal, Spain, Sweden, Turkey, United States, Viet Nam
Contacts
Public ContactClinical Study Information Center
AstraZeneca
Outcome results
None listed