A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)

Annualised rate of moderate or severe COPD exacerbations

Timeframe: Baseline up to 76 weeks

The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo.

Change from baseline in post-BD FEV1

Timeframe: From baseline to Week 52

Change from baseline in post-BD FEV1 at Week 52 compared to placebo. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration

Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)

Timeframe: From baseline to Week 52

Change from baseline in pre-BD FEV1 at Week 52 compared to placebo. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.

Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score

Timeframe: From baseline over 52 weeks

Change from baseline in the SGRQ total score over 52 weeks compared to placebo. SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with lower scores indicating better health status.

Annualised rate of moderate or severe COPD exacerbations among participants with EOS ≥ 300 cells/µL collected during screening visit.

Timeframe: Baseline up to 76 weeks

The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo among participants with EOS ≥ 300 cells/µL collected during screening visit.

Annualised rate of severe COPD exacerbations

Timeframe: Baseline up to 76 weeks

The annualised severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo.

Annualised rate of COPD exacerbations requiring ER visit and/or hospitalisation

Timeframe: Baseline up to 76 Weeks

The annualised rate of COPD exacerbation requiring ER visit and/or hospitalisation up to 76 weeks treatment period compared to placebo.

Clinical meaningful improvement in St. George's Respiratory Questionnaire (SGRQ) total score

Timeframe: From baseline over 52 weeks

Participants achieving a clinically meaningful improvement from baseline in SGRQ total score (4-point score decrease) over 52 weeks. SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with lower scores indicating better health status.

Change from baseline in the COPD assessment Test (CAT) total score

Timeframe: From baseline over 52 weeks

Change from baseline in the CAT total score over 52 weeks CAT is an 8-item PRO that measures the impact of COPD on the health status of patients with COPD. The CAT has a scoring range of 0-40 with higher scores indicative of greater COPD impact on health status.

Clinical meaningful improvement in COPD Assessment Test (CAT) total score

Timeframe: From baseline over 52 weeks

Participants achieving a clinically meaningful improvement from baseline in CAT total score (2-point score decrease) over 52 weeks. CAT is an 8-item PRO that measures the impact of COPD on the health status of patients with COPD. The CAT has a scoring range of 0-40 with higher scores indicative of greater COPD impact on health status.

Time to first moderate or severe COPD exacerbation

Timeframe: Baseline up to 76 weeks

Time to first occurrence of moderate or severe COPD exacerbation up to 76 weeks.

Time to first severe COPD exacerbation

Timeframe: Baseline up to 76 weeks

Time to first occurrence of severe COPD exacerbation up to 76 weeks.

Pharmacokinetics (PK): Serum trough concentrations

Timeframe: Baseline, Week 24, Week 36, Week 52

Serum trough concentrations

Immunogenicity of anti-drug antibodies (ADA)

Timeframe: Baseline, Week 24, Week 36, Week 52

Incidence of anti-drug antibodies