A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up period of 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
990
Tezepelumab subcutaneous injection
Placebo subcutaneous injection
Annualised rate of moderate or severe COPD exacerbations
The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo.
Time frame: Baseline up to 76 weeks
Change from baseline in post-BD FEV1
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
Time frame: From baseline to Week 52
Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)
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
Time frame: From baseline to Week 52
Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score
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.
Time frame: From baseline over 52 weeks
Annualised rate of moderate or severe COPD exacerbations among participants with EOS ≥ 300 cells/µL collected during screening visit.
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.
Time frame: Baseline up to 76 weeks
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Research Site
Cullman, Alabama, United States
RECRUITINGResearch Site
Phoenix, Arizona, United States
RECRUITINGResearch Site
Scottsdale, Arizona, United States
RECRUITINGResearch Site
Inglewood, California, United States
WITHDRAWNResearch Site
Los Angeles, California, United States
RECRUITINGResearch Site
Palo Alto, California, United States
RECRUITINGResearch Site
Redding, California, United States
RECRUITINGResearch Site
San Diego, California, United States
RECRUITINGResearch Site
New Britain, Connecticut, United States
RECRUITINGResearch Site
Wilmington, Delaware, United States
RECRUITING...and 258 more locations
Annualised rate of severe COPD exacerbations
The annualised severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo
Time frame: Baseline up to 76 weeks
Annualised rate of COPD exacerbations requiring ER visit and/or hospitalisation
The annualised rate of COPD exacerbation requiring ER visit and/or hospitalisation up to 76 weeks treatment period compared to placebo.
Time frame: Baseline up to 76 Weeks
Clinical meaningful improvement in St. George's Respiratory Questionnaire (SGRQ) total score
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.
Time frame: From baseline over 52 weeks
Change from baseline in the COPD assessment Test (CAT) total score
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.
Time frame: From baseline over 52 weeks
Clinical meaningful improvement in COPD Assessment Test (CAT) total score
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 frame: From baseline over 52 weeks
Time to first moderate or severe COPD exacerbation
Time to first occurrence of moderate or severe COPD exacerbation up to 76 weeks
Time frame: Baseline up to 76 weeks
Time to first severe COPD exacerbation
Time to first occurrence of severe COPD exacerbation up to 76 weeks
Time frame: Baseline up to 76 weeks
Pharmacokinetics (PK): Serum trough concentrations
Serum trough concentrations
Time frame: Baseline, Week 24, Week 36, Week 52
Immunogenicity of anti-drug antibodies (ADA)
Incidence of anti-drug antibodies
Time frame: Baseline, Week 24, Week 36, Week 52