Recruiting
Sponsor ID
D5241C00006

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

Sponsor ID
D5241C00006
Clinicaltrials.gov ID
NCT06883305
EUCTIS ID
N/A
EudraCT ID
N/A

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)

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
N/A
Enrollment
990
Additional Study Details

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
Status
Contact Us
Location
Research Site
Foley, Alabama, United States, 36535
Status
Recruiting
Location
Research Site
Mobile, Alabama, United States, 36609
Status
Recruiting
Location
Research Site
Sheffield, Alabama, United States, 35660
Status
Recruiting
Location
Research Site
Phoenix, Arizona, United States, 85012
Status
Not yet recruiting
Location
Research Site
Phoenix, Arizona, United States, 85027
Status
Recruiting
Location
Research Site
Tucson, Arizona, United States, 85704
Status
Withdrawn
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