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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

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)

Key facts

Study ID

NCT06883305

Run by

AstraZeneca

People needed

990

Starts

2025-03-18

Expected to finish

2029-06-05

Last updated by the study team

2026-06-24

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Research Site — Palos Hills, Illinois, United States (enrolling)
• Research Site — Munster, Indiana, United States (enrolling)
• Research Site — Foley, Alabama, United States (enrolling)
• Research Site — Phoenix, Arizona, United States (enrolling)
• Research Site — Sheffield, Alabama, United States (enrolling)
• Research Site — Winfield, Illinois, United States (enrolling)
• Research Site — Mobile, Alabama, United States (enrolling)
• Research Site — Torrance, California, United States (enrolling)
• Research Site — Clearwater, Florida, United States (enrolling)
• Research Site — Cutler Bay, Florida, United States (enrolling)
• Research Site — Cutler Bay, Florida, United States (enrolling)
• Research Site — DeBary, Florida, United States (enrolling)
• Research Site — Garden Grove, California, United States (enrolling)
• Research Site — Homestead, Florida, United States (enrolling)
• Research Site — Miami, Florida, United States (enrolling)
• Research Site — Newport Beach, California, United States (enrolling)
• Research Site — Miami, Florida, United States (enrolling)
• Research Site — Miami, Florida, United States (enrolling)
• Research Site — Orlando, Florida, United States (enrolling)
• Research Site — Tampa, Florida, United States (enrolling)
• Research Site — Tampa, Florida, United States (enrolling)
• Research Site — Atlanta, Georgia, United States (enrolling)
• Research Site — Lithonia, Georgia, United States (enrolling)
• Research Site — Rincon, Georgia, United States (enrolling)
• Research Site — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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