Tezepelumab for Moderate to Very Severe COPD

This study is testing a drug called tezepelumab to see if it can help adults with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). Participants will receive either tezepelumab or a placebo (an inactive substance) as a shot under the skin. The main goal is to see if tezepelumab can reduce the number of moderate or severe COPD flare-ups (exacerbations) over about 76 weeks. You might be able to join if you are 40 to 80 years old, have had COPD for at least a year, and have experienced at least two moderate or one severe COPD flare-up in the past year. The study is currently not recruiting, as its status is unclear.

Study design
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study involving about 990 participants.
What's involved
Participants will receive monthly subcutaneous injections for a maximum of 76 weeks and a minimum of 52 weeks.
Compensation
Not stated in the trial record.
Follow-up
There is a 12-week safety follow-up period after treatment ends.

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NCT06878261

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)

Recruiting
PHASE3Ages 40–80InterventionalTreatment
AstraZeneca
~990 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:TezepelumabPlacebo

At a glance

Recruiting sites
233 of 268 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Annualised rate of moderate or severe COPD exacerbations
Measured over Baseline up to 76 weeks
Chronic Obstructive Pulmonary Disease (COPD)
268 sites across 48 states
Japan47
Bulgaria17
Florida13
Argentina12
Peru10
Texas9
Vietnam9
Australia8
  • MeiLan Han, MD · PRINCIPAL_INVESTIGATOR · University of Michigan Health, Pulmonary & Critical Care Medicine,
AstraZeneca Clinical Study Information Center
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Eligibility criteria

Exclusion

Macrolides (less than 6 months)
Systemic immuno-suppressive, -modulating medications 6. LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT
  • Annualised rate of moderate or severe COPD exacerbationsBaseline up to 76 weeks

    The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo.