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

What this study is about

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)

Who can join (things the study team will check)

✅ You may be able to join if…

• ≥40 to ≤80 years old
• COPD diagnosis ≥1 year,
• Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC <0.70 at screening
• Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1
• ≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy
• EOS ≥ 150 cells/μL during screening
• CAT ≥15 at screening
• Former or current smokers ≥10 pack-years

🚫 You may not be able to join if…

• Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD
• Asthma, incl. pediatric, or ACOS
• Any unstable disorder that can impact participants safety or study outcomes
• Tuberculosis requiring treatment within 12 months prior V2
• Malignancies current or past Concomitant therapies:
  • Macrolides (less than 6 months)
  • Systemic immuno-suppressive, -modulating medications
• LTOT >4.0 L/min or O2 saturation <89% despite LTOT

Where this trial is running

• Research Site, Foley, Alabama, United States
• Research Site, Mobile, Alabama, United States
• Research Site, Sheffield, Alabama, United States
• Research Site, Phoenix, Arizona, United States
• Research Site, Phoenix, Arizona, United States
• Research Site, Tucson, Arizona, United States
• Research Site, Garden Grove, California, United States
• Research Site, Newport Beach, California, United States
• Research Site, Torrance, California, United States
• Research Site, Clearwater, Florida, United States
• Research Site, Cutler Bay, Florida, United States
• Research Site, Cutler Bay, Florida, United States

+ 289 more sites.

Who to contact

AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06883305.