Study identifier:D5241C00001
ClinicalTrials.gov identifier:NCT04039113
EudraCT identifier:2019-001363-67
CTIS identifier:N/A
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (COURSE)
Chronic obstructive pulmonary disease (COPD)
Phase 2
No
-
All
337
Interventional
40 Years - 80 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 May 2025 by AstraZeneca
AstraZeneca
Amgen
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)
This is a Phase 2a, 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 triple inhaled maintenance therapy, and having had 2 or more documented COPD exacerbations in the 12 months prior to Visit 1. Approximately, 338 subjects will be randomized globally. Subjects will be stratified by region and prior number of exacerbations (2 vs. 3 or more). Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 52 week treatment period. The study also includes a post-treatment follow-up period of 12 weeks.
Location
Location
New Haven, CT, United States, 06510
Location
Truro, NS, Canada, B2N 1L2
Location
Montréal, QC, Canada, H1M 1B1
Location
Quebec, QC, Canada, G3K 2P8
Location
Burlington, ON, Canada, L7N 3V2
Location
St Charles Borromee, QC, Canada, J6E 2B4
Location
Calgary, AB, Canada, T2N 4Z6
Location
Seoul, Republic of Korea, 06591
Arms | Assigned Interventions |
---|---|
Active Comparator: Tezepelumab Tezepelumab, SC, Q4W | Biological/Vaccine: Tezepelumab Tezepelumab subcutaneous injection Other Name: Tezepelumab |
Placebo Comparator: Matching Placebo Matching placebo, SC, Q4W | Other: Placebo Placebo subcutaneous injection |
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