RecruitingPHASE3INTERVENTIONAL

Long-term Safety and Tolerability of Tozorakimab in Patients With COPD and History of Exacerbations

The ROMEO study is looking at a new medicine called tozorakimab for people with a lung condition called Chronic Obstructive Pulmonary Disease (COPD). Specifically, it's for people who have experienced flare-ups of their COPD. This is a long-term study to see how safe the medicine is over time, using two different doses. To join, you must have already taken part in a previous study for tozorakimab. The main goal is to understand if the medicine has any side effects when used for a longer period. By carefully monitoring participants, researchers hope to gather important information about its safety, which could help future patients with COPD.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

Start

05 May 2026

Estimated completion

29 Dec 2028

Chronic Obstructive Pulmonary Disease COPD

What is this study about?

This study, known as ROMEO, is focused on a medicine called tozorakimab. It's designed for people who have Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that makes it hard to breathe. If you've had flare-ups or 'exacerbations' of your COPD in the past, this study might be relevant to you. The main purpose of ROMEO is to look closely at the long-term safety of tozorakimab when taken over an extended period. Researchers want to make sure it's well-tolerated and to understand any potential side effects.

The study involves two different ways of taking tozorakimab, which are called 'dose regimens'. By studying these over time, the research team can learn how safe each approach is. This is a continuation study, meaning you would have already taken part in a similar study for tozorakimab previously. Taking part helps researchers gather crucial information about this potential new treatment for COPD, which could eventually benefit many people with the condition.

Understanding the long-term safety of any new medicine is really important before it can be widely used. This study contributes to that understanding by carefully monitoring participants over time. Your involvement would help scientists learn more about how tozorakimab works and whether it can be a safe and effective option for people living with COPD.

Key takeaways

This study is for people with COPD who have had flare-ups.
It's testing the long-term safety of a new medicine called tozorakimab.
You must have joined a previous tozorakimab study to be eligible.
Participants will receive the study medicine and have regular health checks.
The main goal is to understand how safe the medicine is over time.

Who may be eligible?

To join the ROMEO study, you must have already taken part in an earlier study for tozorakimab. This study is specifically for people who have been previously involved in one of those related trials.

There are also some important health conditions that would prevent you from joining. For example, if you have other serious lung diseases that aren't COPD, or if you've recently had certain treatments like high-dose steroids or some types of vaccinations, you wouldn't be able to participate. You also couldn't join if you're taking long-term medications that weaken your immune system, or if you've had severe allergic reactions to similar types of medicines in the past.

Basically, if you're in good general health apart from your COPD, have completed a previous tozorakimab study, and don't have any of the specific conditions or recent treatments mentioned, you might be suitable for the ROMEO study. Your doctor would help determine if it's right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you previously taken part in a study for tozorakimab?
Do you have COPD and have you experienced flare-ups?
Do you have any other serious lung diseases besides COPD?
Have you recently received certain strong medications, like high-dose steroids, or some vaccinations?
Do you have any severe allergies to similar types of medicines or any of the study drug's ingredients?

Answer every question to see your result.

What does participation involve?

This study is an 'extension' study, meaning you would have already taken part in a previous study looking at tozorakimab. You would continue to receive the study medicine, tozorakimab, usually as an injection. The study will involve regular visits to a clinic for health checks, blood tests, and to make sure you're doing well and that the medicine is safe for you. The total duration of your participation would be for an extended period, as this is a long-term safety study. The exact number of visits, tests, and the total time in the study would be fully explained by the study team, tailored to your specific 'dose regimen'.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving continued monitoring of your COPD and access to a new investigational treatment. However, as with all medicines, there are potential risks, including side effects from tozorakimab that we might not yet fully understand, especially with long-term use. The study team will explain all known side effects and risks to you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (13)

Research Site
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Aix-en-Provence, France· Recruiting
Research Site
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Brest, France· Recruiting
Research Site
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Colmar, France· Withdrawn
Research Site
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Gleizé, France· Recruiting
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Grenoble, France· Recruiting
Research Site
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Lyon, France· Recruiting
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Marseille, France· Recruiting
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Montpellier, France· Recruiting
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Pessac, France· Recruiting
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Pringy, France· Recruiting
Research Site
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Quimper, France· Recruiting
Research Site
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Saint-Herblain, France· Recruiting

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung condition that causes breathing difficulties, usually due to long-term exposure to harmful gases or particles, most often from smoking.

What does 'exacerbation' mean?

In COPD, an exacerbation means a flare-up or worsening of your normal breathing symptoms. It often requires changes to your medication or a hospital visit.

What is tozorakimab?

Tozorakimab is an investigational medicine being studied for COPD. 'Investigational' means it's still being tested and is not yet approved for general use.

Why is this study only for people who have already been in another study?

This is an 'extension' study. It's designed to see how safe the medicine is over a longer period in people who have already safely started it in previous research studies.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect your usual medical care.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.