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Tezepelumab for Moderate to Very Severe COPD

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

Recruiting Phase 3 Interventional Study
Chronic Obstructive Pulmonary Disease (COPD)
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
40 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
990 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for

This trial is looking for adults aged 40 to 80 who have had COPD for at least a year. Participants will take the study drug Tezepelumab and be monitored for its effects on their condition.

Are You a Good Fit for This Trial?
Must be taking ICSLABALAMA

You may be able to join if

  • I am between 40 and 80 years old.
  • I have been diagnosed with COPD for at least 1 year.
  • I have had at least 2 moderate or 1 severe COPD flare-ups in the past year.
  • I have a specific level of lung function as measured in a test.
  • I have been using inhaled COPD medications for at least 3 months.
  • I have a certain level of eosinophils in my blood.
  • I have a CAT score of 15 or higher.
  • I am a former or current smoker with a history of at least 10 pack-years.

You may not be able to join if

  • I have a serious lung disease other than COPD.
  • I have asthma or conditions associated with asthma.
  • I have any unstable health condition that could affect my safety.
  • I have had tuberculosis that needed treatment in the last year.
  • I have cancer now or have had it in the past.
  • I use oxygen therapy that requires more than 4.0 L/min.
  • I have been taking macrolides in the last 6 months.
  • I am using medications that suppress or modify my immune system.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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)

Trial Locations

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Eligibility Criteria
Inclusion Criteria: 1. ≥40 to ≤80 years old 2. COPD diagnosis ≥1 year, 3. Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening 4. Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1 5. ≥2 moderate or ≥1 sev…
Contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

CONTACT

NCT ID: NCT06878261 Source: ClinicalTrials.gov