Not recruiting

Study of Tozorakimab to reduce exacerbations in former smokers with 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 focuses on testing a medication called Tozorakimab in people with Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that causes breathing difficulties and persistent cough with mucus. The study aims to determine how well two different dose schedules of Tozorakimab work in reducing the frequency of disease flare-ups in former smokers who experience COPD symptoms.

The study medication Tozorakimab will be given as an injection under the skin, alongside the regular COPD treatments that participants are already taking. Some participants will receive Tozorakimab while others will receive placebo, in addition to their standard COPD medications. Participants may also use salbutamol, a rescue inhaler medication that helps to quickly relieve breathing difficulties when needed.

The study will last for 52 weeks, during which participants will need to attend regular clinic visits for health assessments. Throughout the study, doctors will monitor how often participants experience COPD flare-ups, which are periods when their symptoms become notably worse than usual. These flare-ups can range from moderate to severe and may require additional medical treatment.

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 screening
Your eligibility for the study will be confirmed based on specific criteria, including:
- Age 40 years or older
- Diagnosed with COPD (Chronic Obstructive Pulmonary Disease) for at least one year
- History of breathing problems in the past 12 months
- Current use of inhaled medications for at least 3 months
- Past smoking history of 10 pack-years or more
- Specific breathing test results will be required
Step 2
Treatment assignment
You will be randomly assigned to receive one of three treatments:
- Tozorakimab injection under the skin at one of two different dose levels
- Placebo injection (contains no active medication)
All participants will continue their regular COPD medications throughout the study
Step 3
Treatment period
The study will continue until May 2026
You will receive regular injections under the skin
Your regular inhaled medications will continue as prescribed
Salbutamol inhaler will be provided as rescue medication when needed
Step 4
Monitoring
Regular assessments will track your COPD symptoms
Any breathing problems or COPD exacerbations (worsening of symptoms) will be recorded
Your breathing function will be tested periodically
Your overall health and safety will be monitored throughout the study

Who can join the trial?

9 criteria

Must be at least 40 years old and able to provide signed informed consent
Must have been diagnosed with COPD (Chronic Obstructive Pulmonary Disease) for at least 1 year before joining the study
check
Must have specific lung function test results showing:
- A ratio of FEV1/FVC less than 0.70 (This measures how much air you can exhale)
- A FEV1 greater than 20% of what would be normal for you
- check
  Must have experienced in the past 12 months either:
  - At least 2 moderate flare-ups of COPD, or
  - At least 1 severe flare-up of COPD
  - Must be using prescribed inhaled medications (either two or three different types) at a stable dose for at least 3 months
  - Must have a history of smoking at least 10 pack-years (For example: smoking 1 pack per day for 10 years, or 2 packs per day for 5 years)
  - Must score 10 or higher on the CAT assessment (a questionnaire that measures COPD symptoms), with scores of 2 or higher for both cough and phlegm symptoms

Who cannot join the trial?

14 criteria

Active or former smokers who have quit smoking less than 12 months ago
History of asthma (a condition causing breathing difficulties)
Current lung infections or active respiratory illness other than COPD
Significant heart problems or cardiovascular disease
History of cancer within the past 5 years
Use of immunosuppressive medications (drugs that weaken the immune system)
Active or chronic infections including tuberculosis, hepatitis B, or HIV
Severe liver or kidney disease
Participation in other clinical trials within the past 30 days
Known allergies to study medications or their components
Pregnancy, breastfeeding, or planning to become pregnant
Unable to perform required study procedures or follow-up visits
Mental conditions that could interfere with study compliance
Drug or alcohol abuse within the past year

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Verified sites

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

Verified
ASST Fatebenefratelli Sacco
Milan, Italy
Responsive
Azienda Ospedaliero Universitaria Di Sassari
Sassari, Italy
Responsive
Ludwig Maximilian University Of Munich
Munich, Germany

Trial locations

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Investigated drugs

Tozorakimab
is a medication being studied as an additional treatment for people with Chronic Obstructive Pulmonary Disease (COPD). It is designed to help reduce the frequency of COPD flare-ups (exacerbations) in people who used to smoke. The medication is given alongside standard COPD treatments to see if it can provide better control of the disease symptoms and prevent worsening of the condition.
Standard of care
refers to the usual medications and treatments that COPD patients typically receive, which may include inhaled bronchodilators and corticosteroids. In this study, all participants continue their regular COPD treatments while either receiving tozorakimab or placebo.

What is already known about the treatment

Tozorakimab - A novel investigational biological medication administered via injection for the treatment of Chronic Obstructive Pulmonary Disease (COPD), currently being studied in Phase III clinical trials. This drug is designed to work as an add-on therapy to standard COPD treatments, specifically targeting the reduction of moderate to severe exacerbations in former smokers. While its exact molecular mechanism of action is still being investigated through clinical trials, it represents a new class of biological treatments for COPD, aiming to provide additional therapeutic options beyond conventional treatments. The drug is being evaluated in different dose regimens to determine its optimal therapeutic effect and safety profile in COPD patients.

Investigated diseases

Chronic Obstructive Pulmonary Disease (COPD) - A progressive lung condition that causes breathing difficulties due to narrowed airways and damaged lung tissue. The disease typically develops over many years, mainly affecting the bronchi and air sacs in the lungs. COPD makes it increasingly difficult to breathe, particularly during physical activity, as the airways become inflamed and thickened. The condition is characterized by persistent respiratory symptoms, including shortness of breath, chronic cough, and increased mucus production. The disease causes the lungs to gradually lose their elastic quality and become less efficient at moving air in and out.