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Study of Tozorakimab for Patients with Chronic Obstructive Pulmonary Disease Who Have Symptoms and a History of Flare-ups

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What is this trial about?

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

This study involves people with Chronic Obstructive Pulmonary Disease, also known as COPD, which is a long-term lung condition that makes breathing difficult and causes symptoms like coughing and mucus production. The study is looking at a medication called Tozorakimab, which is also known by its code name MEDI3506. Some participants will receive Tozorakimab while others will receive placebo. Participants may also use Salbutamol, which is a type of short-acting medication that helps open the airways when breathing becomes difficult. All participants will continue using their regular COPD medications during the study.

The purpose of this study is to see whether Tozorakimab can reduce the number of times COPD symptoms suddenly get worse, which are called exacerbations. These exacerbations are episodes when breathing problems become more severe than usual and may require additional treatment or even hospitalization. The study will compare two different amounts of Tozorakimab given as an injection under the skin to placebo, which will be added to the standard medications that participants are already taking for their COPD.

The study will last for about 52 weeks. During this time, participants will receive regular injections of either Tozorakimab or placebo, and doctors will monitor how often their COPD symptoms worsen and how severe these episodes are. The study focuses on people who have had at least two moderate episodes or one severe episode of worsening COPD symptoms in the past year, who are former smokers, and who continue to have symptoms despite using their regular COPD medications.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and confirmation of eligibility
Your lung function will be measured after receiving a bronchodilator medication. This test will check if your FEV1/FVC ratio (the amount of air you can forcefully exhale in one second compared to your total lung capacity) is below 0.70, and that your FEV1 is above 20% of the expected normal value.
Your medical history will be reviewed to confirm you have had a diagnosis of chronic obstructive pulmonary disease for at least one year.
Your history of COPD exacerbations (episodes when your symptoms suddenly worsen) will be verified. You must have experienced at least 2 moderate episodes or at least 1 severe episode in the past 12 months.
Your current inhaled medications will be reviewed to confirm you have been using a stable dose of dual or triple therapy for at least 3 months.
You will complete the CAT questionnaire (COPD Assessment Test) to measure your symptoms. Your total score must be 10 or higher, and your phlegm and cough scores must each be 2 or higher.
Step 2
Random assignment to treatment group
You will be randomly assigned to one of three groups: one group receiving tozorakimab at a specific dose regimen, another group receiving tozorakimab at a different dose regimen, or a group receiving placebo (an inactive substance that looks like the medication but contains no active ingredient).
Neither you nor your healthcare provider will know which treatment you are receiving during the study. This is called a double-blind design.
Step 3
Treatment administration
You will receive injections of either tozorakimab or placebo under your skin (subcutaneous injection). The specific dosage and frequency will depend on which treatment group you are assigned to.
You will continue receiving these injections throughout the treatment period on a regular schedule.
You will continue taking your existing inhaled medications (dual or triple therapy) as prescribed by your doctor throughout the study.
You may use salbutamol (a rescue inhaler) as needed to relieve sudden breathing difficulties.
Step 4
Regular monitoring visits
You will attend scheduled visits at the study site throughout the treatment period.
During these visits, your lung function will be assessed, and any changes in your symptoms will be recorded.
Any episodes of COPD exacerbations (when your breathing problems suddenly get worse) will be documented and classified as moderate or severe.
Your healthcare provider will monitor you for any side effects or adverse reactions to the treatment.
Step 5
Completion of treatment period
The treatment period will continue for the duration specified in the study protocol.
The study is expected to continue until May 2026, though your individual participation duration may vary.
Final assessments will be conducted to evaluate the overall effect of the treatment on the frequency of your COPD exacerbations and your general health status.

Who can join the trial?

7 criteria

You must be 40 years of age or older and able to provide written permission to join the study
You must have a confirmed diagnosis of COPD, which is a lung disease that makes breathing difficult, for at least one year before joining
Your lung function tests must show specific results: after using a bronchodilator (a medicine that opens airways), the ratio of air you can breathe out in one second compared to total air you can breathe out must be less than 0.70, and the amount of air you can breathe out in one second must be more than 20% of what is expected for a healthy person
You must have had at least 2 moderate flare-ups or at least 1 severe flare-up of your COPD in the 12 months before joining. A flare-up means your symptoms suddenly got worse
You must have been using an optimized inhaled therapy with either two or three medicines combined at a stable dose for at least 3 months before joining
You must have a smoking history of at least 10 pack-years. A pack-year means smoking one pack of cigarettes per day for one year
Your CAT score must be 10 or higher. The CAT is a questionnaire that measures how COPD affects your daily life. Additionally, your scores for phlegm (thick mucus from your lungs) and cough must each be 2 or higher on this questionnaire

Who cannot join the trial?

8 criteria

The study does not list specific exclusion criteria in the provided information, which means the detailed reasons why patients cannot participate are not available in this dataset.
Generally, clinical trials have requirements about other health conditions, medications you are taking, or previous treatments that might prevent you from joining, but these specific details are not included here.
If you have serious lung diseases other than COPD (a lung condition that makes it hard to breathe), this might affect your ability to participate.
If you are currently smoking, you may not be able to join, as this study is specifically for former smokers (people who used to smoke but have stopped).
Certain other ongoing medical conditions or treatments may prevent participation, but the specific conditions are not listed in the available information.
Pregnancy or plans to become pregnant during the study may be a reason you cannot participate, as this is common in clinical trials testing new medications.
Allergies to the study medication or similar treatments might prevent you from joining.
Recent participation in other clinical trials may be a reason for exclusion.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium
Responsive
Pneumocare
Namur, Belgium
Responsive
Sykehuset I Vestfold HF
Tonsberg, Norway

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Investigated drugs

Tozorakimab is an investigational medication being tested in this clinical trial. It is given as an add-on treatment to the usual standard care that patients with chronic obstructive pulmonary disease (COPD) already receive. The purpose of testing this medication is to see if it can help reduce the number of times patients experience moderate to severe flare-ups of their COPD symptoms. In this study, tozorakimab is being compared against a placebo to determine if it is effective and safe for people who have symptomatic COPD and a history of exacerbations.

What is already known about the treatment

Tozorakimab – Tozorakimab is an investigational medication currently being studied in Phase III clinical trials for the treatment of Chronic Obstructive Pulmonary Disease (COPD), specifically in patients who experience frequent disease flare-ups and have a history of smoking. This medication is administered as an add-on therapy to standard COPD treatments and works by targeting specific molecules in the body that contribute to inflammation and worsening of lung symptoms. The main goal of the clinical research is to determine whether tozorakimab can reduce the number of moderate to severe COPD exacerbations (sudden worsening episodes) when compared to placebo, potentially helping patients breathe better and experience fewer hospitalizations.

Investigated diseases

Chronic Obstructive Pulmonary Disease – Chronic Obstructive Pulmonary Disease is a long-term lung condition that makes it difficult to breathe. The airways in the lungs become narrowed and damaged, which blocks the flow of air in and out of the lungs. The disease develops gradually over many years, usually caused by smoking or long-term exposure to harmful particles in the air. People with this condition often experience shortness of breath, persistent cough, and frequent chest infections called exacerbations. These exacerbations are episodes when symptoms suddenly get worse and can vary from moderate to severe. The disease is progressive, meaning it continues to worsen over time if the harmful exposure continues.