A Study of Tezepelumab for Moderate to Very Severe COPD

This study is testing a medication called tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD). Tezepelumab is given as an injection under the skin. Some participants will receive tezepelumab, while others will receive a placebo (an inactive injection that looks like the study drug). The main goal is to see if tezepelumab can reduce the number of moderate or severe COPD flare-ups (exacerbations) over about 76 weeks, and to check its safety. You may be able to join if you are between 40 and 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 recruiting about 990 participants.

Study design
This is a Phase 3, randomized, double-blind study, meaning neither you nor your doctor will know if you are receiving tezepelumab or a placebo. The study plans to enroll about 990 participants.
What's involved
Participants will receive monthly subcutaneous injections of tezepelumab or placebo for a minimum of 52 weeks and a maximum of 76 weeks.
Compensation
Not stated in the trial record.
Follow-up
After the treatment period, there will be a safety follow-up period of 12 weeks.

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NCT06883305

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

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

At a glance

Recruiting sites
255 of 301 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)
301 sites across 48 states
China62
India21
Mexico16
Brazil15
Poland15
Florida13
South Korea12
Czechia10
  • Dave Singh, MD · PRINCIPAL_INVESTIGATOR · Division of Infection, Immunity & Resp Medicine, The University of Manchester, United Kingdom
AstraZeneca Clinical Study Information Center
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Do you actually qualify for this trial?

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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.