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RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well tezepelumab works and how safe it is compared with a placebo, a treatment with no active drug. It is for adults ages 40 to 80 with moderate to very severe COPD, a long-term lung disease that makes breathing hard.

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)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 40 to 80 years old and have had a COPD diagnosis for at least 1 year.
  • After taking medicine to open your airways, your breathing test results meet the study limits: FEV1 is 20% to 70% of the predicted normal value, and FEV1/FVC is below 0.70.
  • You have used three types of inhaled COPD medicines for at least 3 months before the first visit, or two types if three are not right for you.
  • You had at least 2 moderate COPD flare-ups or 1 severe flare-up in the past year. At least 1 of the 2 moderate flare-ups needed steroid pills or shots. At least 1 flare-up happened while you were using your regular two- or three-type inhaled treatment.
  • Your screening blood test shows at least 150 eosinophils per microliter. These are a type of white blood cell.
  • Your COPD Assessment Test (CAT), which measures symptoms, has a score of at least 15 at screening.
  • You smoke now or used to smoke, with at least 10 pack-years of smoking. This equals 1 pack a day for 10 years or 2 packs a day for 5 years.

Who can't join

  • You have another important lung disease, or lung images suggest a breathing disease other than COPD.
  • You have asthma, including childhood asthma, or both asthma and COPD.
  • You have an unstable health problem that could affect your safety or the study results.
  • You had tuberculosis, a lung infection, that needed treatment within 12 months before the second visit.
  • You have cancer now or had it in the past.
  • You have used macrolide antibiotics for less than 6 months.
  • You use medicines that suppress or change the immune system throughout the body.
  • You need long-term oxygen at more than 4 liters per minute, or your blood oxygen level stays below 89% despite long-term oxygen treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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

Study sites (73)

AL

AZ

CA

FL

GA

ID

IL

IN

MA

MD

MI

MN

MO

MT

NC

NE

NJ

NM

NV

NY

OH

OK

PA

SC

TN

TX

UT

WI

WV