Recruiting
Sponsor ID
D5241C00007
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)JOURNEY
Study Details
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)
Protocol Summary
Primary Outcome Measures
Annualised rate of moderate or severe COPD exacerbations
Timeframe: Baseline up to 76 weeks
Secondary Outcome Measures
Change from baseline in post-BD FEV1
Timeframe: From baseline to Week 52
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 the St. George's Respiratory Questionnaire (SGRQ) total score
Timeframe: From baseline over 52 weeks
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
Annualised rate of severe COPD exacerbations
Timeframe: Baseline up to 76 weeks
Annualised rate of COPD exacerbations requiring ER visit and/or hospitalisation
Timeframe: Baseline up to 76 Weeks
Clinical meaningful improvement in St. George's Respiratory Questionnaire (SGRQ) total score
Timeframe: From baseline over 52 weeks
Change from baseline in the COPD assessment Test (CAT) total score
Timeframe: From baseline over 52 weeks
Clinical meaningful improvement in COPD Assessment Test (CAT) total score
Timeframe: From baseline over 52 weeks
Time to first moderate or severe COPD exacerbation
Timeframe: Baseline up to 76 weeks
Time to first severe COPD exacerbation
Timeframe: Baseline up to 76 weeks
Pharmacokinetics (PK): Serum trough concentrations
Timeframe: Baseline, Week 24, Week 36, Week 52
Immunogenicity of anti-drug antibodies (ADA)
Timeframe: Baseline, Week 24, Week 36, Week 52
Locations
Location
Research Site
Cullman, Alabama, United States, 35055
Status
Recruiting
Location
Research Site
Phoenix, Arizona, United States, 85044
Status
Recruiting
Location
Research Site
Scottsdale, Arizona, United States, 85258
Status
Recruiting
Location
Research Site
Inglewood, California, United States, 90301
Status
Withdrawn
Location
Research Site
Los Angeles, California, United States, 90048
Status
Recruiting
Location
Research Site
Palo Alto, California, United States, 94304
Status
Recruiting
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