A Phase III, Multicentre, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (Oberon)
This large study is investigating a new medication called Tozorakimab for individuals suffering from Chronic Obstructive Pulmonary Disease (COPD). The main goal is to find out if this medicine can effectively reduce the number of serious COPD flare-ups (exacerbations) that people experience, and to understand if it's safe to use. Some participants will receive Tozorakimab, others will get a placebo (a dummy medicine), and all will continue to use their usual rescue inhaler (Salbutamol). This is a Phase 3 study, meaning it's one of the final stages before a medicine might become widely available. Doctors and researchers are hopeful this could offer a new way to help manage COPD symptoms.
At a glance
What is this study about?
This study is focused on a new medicine called Tozorakimab for people who have Chronic Obstructive Pulmonary Disease, often known as COPD. COPD can make it hard to breathe, and people with it sometimes have sudden worsening of their symptoms, called 'exacerbations' or 'flare-ups'. These can be quite serious and require extra medical help.
The main purpose of this study is to see if Tozorakimab can help reduce how often these serious flare-ups happen. Researchers will also be carefully checking if the new medicine is safe and if people taking it have any side effects. To get clear results, some people in the study will receive Tozorakimab, while others will get a 'placebo', which looks like the real medicine but contains no active drug. This helps scientists compare the effects properly.
This is a 'Phase 3' study, which means it’s a big, important step. Medicines that reach this stage have already shown some promise in earlier studies and are now being tested in a larger group of people to confirm their effectiveness and safety before they might be approved for general use. The information gathered from this study will be very important in understanding if Tozorakimab could become a new treatment option for managing COPD.
Key takeaways
- Investigating a new medicine (Tozorakimab) for COPD.
- Aims to reduce severe COPD flare-ups.
- Compares Tozorakimab to a dummy medicine (placebo).
- It's a large, important 'Phase 3' study.
- Participation involves regular clinic visits and health checks.
- Could help find new treatments for COPD patients.
Who may be eligible?
To join this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.
Crucially, you would have to have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and experienced some flare-ups in the past. The researchers are particularly interested in people who used to smoke but have now stopped.
There might be other specific health conditions or medications that could affect whether you can join, but these are the main points. Your doctor or the study team would go through all the details if you're interested.
- Are you 18 years old or older?
- Have you been diagnosed with COPD?
- Have you had COPD flare-ups (exacerbations) in the past?
- Are you a former smoker?
- Are you able to attend regular clinic appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be given either the new medicine, Tozorakimab, or a dummy medicine (placebo). You won't know which one you are receiving, and neither will the study team. You will also use Salbutamol, a standard rescue inhaler, as needed.
Taking part will involve regular visits to the study clinic where you will have various health checks, such as breathing tests, blood tests, and physical examinations. The study team will explain all the procedures in detail. You'll need to keep track of your symptoms and any flare-ups in a diary. The total length of the study for each participant, including follow-up, will be determined by the study team, but these types of studies typically last for several months or even a year or more. All study medication and appointments related to the trial will be provided at no cost to you.
Potential risks and benefits
Locations (11)
- —Czechia
- —Denmark
- —Bulgaria
- —Netherlands
- —Belgium
- —Finland
- —Hungary
- —Portugal
- —Sweden
- —Spain
- —Norway
Common questions
What is a 'Phase 3' study?
It's one of the final stages of testing a new medicine, involving a large group of people to confirm its effectiveness and safety before it can be approved for wider use.
What does 'placebo-controlled' mean?
It means some people get the new medicine, and others get a 'dummy' medicine that looks the same but contains no active drug, so researchers can compare the effects fairly.
Will I know if I'm getting the new medicine or the dummy medicine?
No, this is a 'double-blind' study, meaning neither you nor the study doctors will know which treatment you are receiving until after the study is complete, to keep the results fair.
What are 'COPD exacerbations'?
These are sudden worsening of your COPD symptoms, like breathlessness, coughing, or wheezing, which might need extra medicine or hospital treatment.
Do I have to pay to take part?
No, all study-related visits, tests, and medications will be provided at no cost to you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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