Study Complete
Sponsor ID
D5241C00001

Tezepelumab COPD Exacerbation StudyCOURSE

Sponsor ID
D5241C00001
Clinicaltrials.gov ID
NCT04039113
EUCTIS ID
N/A
EudraCT ID
2019-001363-67

Study Details

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Additional Study Details

Phase
Phase 2
Product
N/A
Type
Interventional
Masking
N/A
Enrollment
337
Additional Study Details

Protocol Summary

Primary Outcome Measures

Rate of Moderate or Severe COPD Exacerbations in Participants With Moderate to Very Severe COPD.

Timeframe: From randomisation up to Week 52

Secondary Outcome Measures

Time to First Moderate/Severe COPD Exacerbation

Timeframe: From randomisation up to Week 52

Proportion of Participants COPD Exacerbation Free at Week 52

Timeframe: From randomisation up to Week 52

Comparison of Annual Severe COPD Exacerbation Rates Over 52 Weeks

Timeframe: From randomisation up to Week 52

Proportion of Participants With >=1 Severe COPD Exacerbations Over 52 Weeks

Timeframe: From randomisation up to Week 52

Time to First Severe COPD Exacerbation

Timeframe: From randomisation up to Week 52

Least Square (LS) Mean Difference in Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 (FEV1) at Week 52

Timeframe: Baseline and Week 52

Lease Square (LS) Mean Difference in Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52

Timeframe: Baseline and Week 52

Proportion of Participants Achieving a Minimum Clinically Important Difference of 4 Units or More in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52

Timeframe: Baseline and Week 52

Least Square (LS) Mean Difference in Change From Baseline in COPD Assessment Tool (CAT) Total Score at Week 52

Timeframe: Baseline and Week 52

Serum Concentration of Tezepelumab

Timeframe: Pre-dose at weeks 0, 4, 12, 24, 36 and also at weeks 52 and 64 where no dosing was scheduled

Number of Participants With Anti-Drug Antibody (ADA) Response to Tezepelumab

Timeframe: Pre-dose at weeks 0, 4, 12, 24, 36 and also at weeks 52 and 64 where no dosing was scheduled

Study Documents

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Dothan, Alabama, United States, 36305
Status
N/A
Location
Research Site
Huntington Beach, California, United States, 92647
Status
N/A
Location
Research Site
Newport Beach, California, United States, 92663
Status
N/A
Location
Research Site
Upland, California, United States, 91786
Status
N/A
Location
Research Site
Westminster, California, United States, 92683
Status
N/A
Location
Research Site
New Haven, Connecticut, United States, 06510
Status
N/A
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