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Looking for participantsPhase3

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

Sponsor: AstraZeneca

NCT ID: NCT06883305

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Tezepelumab (biological), Placebo (other)
How long the study runs
Study runs about 51 months (dates as stated)
About the drug or intervention
Tezepelumab — biological: Tezepelumab subcutaneous injection · Placebo — other: Placebo subcutaneous injection
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
40 Years to 80 Years
Who
All
Number of participants
990
Started
2025-03-18
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for chronic obstructive pulmonary disease (copd)
  • • Phase3 - 990 participants
  • • 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)

Who can take part?

  • • Ages 40 Years to 80 Years
  • • Diagnosed with chronic obstructive pulmonary disease (copd)

Where?

  • • Bradford - Research Site
  • • Brighton - Research Site
  • • Cottingham - Research Site
  • • Glasgow - Research Site
  • • +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

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)

More detail

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up period of 12 weeks.

Chronic Obstructive Pulmonary Disease (COPD)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years - 80 Years
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ the use of systemic corticosteroids

What the study is looking for

  • ✓≥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...
  • ✓EOS ≥ 150 cells/μL during screening

Who cannot take part

  • ✗Clin. important lung 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
See the full 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 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 6. EOS ≥ 150 cells/μL during screening 7. CAT ≥15 at screening 8. Former or current smokers ≥10 pack-years Exclusion Criteria: 1. Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD 2. Asthma, incl. pediatric, or ACOS 3. Any unstable disorder that can impact participants safety or study outcomes 4. Tuberculosis requiring treatment within 12 months prior V2 5. Malignancies current or past Concomitant therapies: * Macrolides (less than 6 months) * Systemic immuno-suppressive, -modulating medications 6. LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT

Where Is This Study? (9 UK sites)

Research Site

Bradford BD9 6RJ, United Kingdom

Recruiting

Research Site

Brighton BN2 1ES, United Kingdom

Recruiting

Research Site

Cottingham HU16 5JQ, United Kingdom

Recruiting

Research Site

Glasgow G12 0YN, United Kingdom

Recruiting

Research Site

Halifax HX3 0PW, United Kingdom

Recruiting

Research Site

Leeds LS9 7TF, United Kingdom

Recruiting

Research Site

Portsmouth PO6 3LY, United Kingdom

Recruiting

Research Site

Tyne and Wear NE29 8NH, United Kingdom

Recruiting

Research Site

Wakefield WF1 4DG, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09