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Study of Tezepelumab Compared to Placebo in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial investigates the use of tezepelumab in adults with Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung condition that causes breathing difficulties and can lead to frequent chest infections. The study aims to determine if tezepelumab can reduce the frequency of COPD flare-ups compared to placebo in people with moderate to very severe forms of the disease.

The study medication tezepelumab is given as a subcutaneous injection using a pre-filled syringe. Some participants will receive tezepelumab, while others will receive a placebo. Neither the participants nor their doctors will know which treatment is being given during the study.

The treatment period will last for 76 weeks, during which participants will receive regular injections of either tezepelumab or placebo. Throughout the study, doctors will monitor participants' breathing ability, symptoms, and how often they experience COPD flare-ups. The study will also track any changes in participants' quality of life and their ability to perform daily activities.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will receive either tezepelumab or a placebo through subcutaneous injection (an injection under the skin).
The medication used is Tezspire 210 mg solution in a pre-filled syringe.
Your current inhaled therapy for Chronic Obstructive Pulmonary Disease (COPD) will continue during the study.
Step 2
Treatment monitoring - First 52 weeks
Your lung function will be measured regularly using a test called FEV1 (amount of air you can forcefully exhale).
You will complete questionnaires about your symptoms and quality of life.
The medical team will monitor any COPD exacerbations (periods when your symptoms get worse).
Your blood will be tested to measure medication levels and check for antibodies.
Step 3
Extended observation period
The study continues for an additional 24 weeks (total of 76 weeks).
During this time, the medical team will continue to monitor your COPD exacerbations.
The focus will be on tracking both moderate and severe episodes of symptom worsening.
Blood samples will continue to be collected to measure drug levels and antibodies.
Step 4
Final evaluation
Your lung function will be measured one final time.
The medical team will review your complete health status.
All questionnaires about your symptoms and quality of life will be completed for the last time.
A final blood sample will be taken to check medication levels and antibodies.

Who can join the trial?

8 criteria

Age between 40 and 80 years old at the time of signing consent
Diagnosed with COPD (Chronic Obstructive Pulmonary Disease) for at least 12 months before first visit
Have specific lung function test results showing: - Reduced ratio of exhaled air volume (FEV1/FVC less than 0.70) - Lung capacity between 20% and 70% of normal predicted value
Using either: - Triple therapy (three different inhaled medications), or - Dual therapy (two different inhaled medications) for at least 3 consecutive months before first visit
History of either: - At least 2 moderate COPD flare-ups, or - At least 1 severe COPD flare-up in the past 12 months - At least one flare-up must have been treated with steroids
Blood test showing specific white blood cell count (eosinophils at least 150 cells per microliter)
CAT score (COPD Assessment Test measuring symptoms) of 15 or higher at first visit
Must be either: - Current smoker, or - Former smoker who quit at least 6 months ago - Must have smoked equivalent to 10 pack-years (for example: 1 pack per day for 10 years)

Who cannot join the trial?

15 criteria

History of asthma or any other chronic respiratory condition besides COPD
Current active lung infection or tuberculosis
Major surgery within the past 3 months
Unstable heart conditions (like recent heart attack or uncontrolled high blood pressure)
Current cancer treatment or active cancer
Participation in another clinical trial within the past 30 days
Allergic reactions to similar medications in the past
Current use of other biological therapies (special types of medications that affect the immune system)
Severe liver or kidney disease
Autoimmune disorders (conditions where the body's immune system attacks its own tissues)
History of substance abuse within the past 6 months
Pregnant women or women planning to become pregnant during the study
Breastfeeding mothers
Unable to perform breathing tests or use inhalers properly
Any condition that the study doctor believes would make participation unsafe

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Verified sites

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Verified
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Azienda Ospedaliero Universitaria Di Sassari
Sassari, Italy

Trial locations

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Investigated drugs

Tezepelumab is a medication being studied for people with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). It is designed to reduce the frequency and severity of COPD flare-ups (exacerbations). This medication works by targeting specific proteins in the body that are involved in airway inflammation, which is a key feature of COPD. It is given to patients alongside their regular COPD treatments.

Tezepelumab

What is already known about the treatment

Tezepelumab - A biologic medication administered through subcutaneous injection that represents a novel approach in treating chronic obstructive pulmonary disease (COPD). This monoclonal antibody works by targeting thymic stromal lymphopoietin (TSLP), a key protein involved in airway inflammation, which makes it particularly effective for patients with moderate to very severe COPD. Currently undergoing Phase III clinical trials, tezepelumab belongs to the class of biological response modifiers and shows promise in reducing COPD exacerbations by blocking inflammatory pathways in the lungs. The medication is being evaluated for its potential to provide a new treatment option for COPD patients who experience frequent disease flare-ups despite standard therapy.

Investigated diseases

Chronic Obstructive Pulmonary Disease (COPD) - A progressive respiratory condition that makes breathing difficult due to obstruction of airflow in the lungs. The disease causes the airways to become inflamed and narrowed, while also damaging the tiny air sacs (alveoli) in the lungs. COPD typically develops slowly over years, with symptoms including persistent coughing, increased mucus production, wheezing, and shortness of breath, especially during physical activities. The condition often results in reduced lung function and can affect daily activities. The airways become less elastic over time, making it harder to breathe out properly.