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Taking people in Hong KongPhase 3

Tezepelumab Study for Adults With Moderate to Very Severe COPD

Tests tezepelumab against placebo in adults with moderate to very severe COPD.

Key facts

Who runs it
AstraZeneca
Where
Hong Kong, Hong KongSee the siteAlso in 21 other countries, 249 sites
Registry title
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
Status
Recruiting
Phase
Phase 3
People taking part
990 people, planned
Started
25 Mar 2025
Expected to end
5 Jun 2029
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Tezepelumab
  • Placebo
Record updated
9 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 40 to 80 with moderate to very severe COPD who have had flare-ups in the past year and a raised blood eosinophil count.

Age
40 to 80 years
Sex
All sexes can join.
Disease stage
COPD diagnosed for at least 1 year, moderate to very severe, post-bronchodilator FEV1 of at least 20% and at most 70% of predicted, FEV1/FVC below 0.70, CAT score of at least 15.
Earlier treatment
Must have used triple inhaled therapy (ICS+LABA+LAMA), or dual inhaled therapy if triple is not appropriate, for at least 3 months in a row before visit 1. Must have had at least 2 moderate or at least 1 severe flare-up in the past year.
Biomarker or test result
Eosinophils (EOS) of at least 150 cells/μL at screening.

Main reasons for not taking part

  • Other important lung disease besides COPD
  • Asthma, including childhood asthma, or asthma-COPD overlap
  • Any unstable disorder that could affect safety or study results
  • Tuberculosis needing treatment within 12 months before visit 2
  • Current or past cancer

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • ≥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

Who cannot take part

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 80 years old?

Where in Hong Kong

Also in 21 other countries, 249 sites

  • Hong KongHospital not named in the registryTaking people

About the trial

What the trial wants to find out

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)

The 3 groups in the trial

  • Dose 1 of TezepelumabTreatment being tested

    Tezepelumab, SC, Q4W

    Treatment: Tezepelumab

  • Dose 2 of TezepelumabTreatment being tested

    Tezepelumab, SC, Q4W

    Treatment: Tezepelumab

  • Matching PlaceboPlacebo, for comparison

    Matching placebo, SC, Q4W

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Plain-language title
Tezepelumab Study for Adults With Moderate to Very Severe COPDGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06878261, who can take part
Record updated
9 October 2026