RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD)

This research is looking at a new medicine called Lunsekimig for adults living with Chronic Obstructive Pulmonary Disease (COPD). It's a long-term study, lasting up to 100 weeks, focusing on participants who have previously taken Lunsekimig in other trials. The main goals are to understand how safe this treatment is and how well it works over a longer period. Doctors will also be looking closely at how people with a certain type of COPD (where immune cells called eosinophils are involved) respond, and for some, what happens if they try to reduce or stop their usual inhaled steroid medicines while on Lunsekimig. The study will involve regular check-ups to monitor your health and the medicine's effects.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Sanofi

Enrolment target

1,508

Start

16 Sep 2026

Estimated completion

23 Jul 2031

Chronic Obstructive Pulmonary Disease

What is this study about?

This study is designed for adults living with Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that makes it hard to breathe. The specific medicine being studied is called Lunsekimig. This isn't the first time Lunsekimig has been researched; this study is a continuation for people who have already tried it in earlier research studies.

The main purpose of this study is to gather more information on the safety and effectiveness of Lunsekimig over a longer period, up to 100 weeks (about two years). It's particularly interested in people with a type of COPD where certain immune cells, called eosinophils, are thought to play a role. Understanding how Lunsekimig helps these individuals over time is key. For some participants, there's also a part of the study that looks at whether they can reduce or stop their inhaled steroid medicines, which are often used for COPD.

By taking part, you would help researchers learn more about managing COPD with Lunsekimig. This information could be very important for improving treatment options for many people living with this condition in the future. The study is carefully planned to keep you safe and monitor your health closely throughout.

Key takeaways

This study is for adults with COPD who have previously tried Lunsekimig in earlier trials.
It aims to understand the long-term safety and effectiveness of Lunsekimig over two years.
There's an optional part for some to see if inhaled steroids can be reduced or stopped.
Participation involves regular clinic visits (about 26 over 100 weeks) and close monitoring.
You will receive careful medical attention, and you can withdraw at any time.

Who may be eligible?

This study is for adults with COPD, aged between 40 and 80. To be considered, you must have already finished a previous study (EFC18243 or EFC18244) where you received Lunsekimig, and your COPD isn't fully controlled.

There are also some important rules about birth control for both men and women during the study and for a period afterwards. Women who could become pregnant must use effective birth control and agree not to donate eggs. Men must also agree not to donate or freeze sperm.

You would not be able to join if you have new health problems that the study doctor thinks would make it unsafe for you to take part, or if you have a known allergy to Lunsekimig or its ingredients. They will also check if you are taking any medicines that might interfere with the study treatment.

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.

Are you between 40 and 80 years old?
Have you previously taken part in the EFC18243 or EFC18244 Lunsekimig study?
Do you have COPD that isn't fully controlled?
Are you able to follow specific birth control guidelines for the study duration and after?
Do you have any new major health issues or allergies that might stop you from joining?

Answer every question to see your result.

What does participation involve?

If you join this study, it would last for up to 100 weeks, which is about two years. This time includes a treatment period where you would receive Lunsekimig, followed by a short period of about four weeks where your health would still be checked.

Throughout the study, you would have about 26 visits to the clinic. Your first visit would usually be timed to happen around the end of your previous Lunsekimig study. At these visits, doctors and nurses would carefully monitor your health, how you're reacting to the medicine, and how your COPD is doing. For some, there's also a specific part of the study that explores reducing or stopping inhaled steroid medicines, and this would be closely supervised.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new treatment that might help manage your COPD symptoms over a long period. However, like all medicines, Lunsekimig may have side effects, and these would be carefully monitored throughout the study. There are no guarantees of benefit, and the treatment might not work for everyone. You would receive regular medical check-ups and close attention from the study team. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Newport Native MD- Site Number : 8403003
Verified postcode
Newport Beach, United States· Recruiting
Helix Biomedics- Site Number : 8403065
Verified postcode
Boynton Beach, United States· Recruiting
Investigational Site Number : 8264017
Verified postcode
Rotherham, United Kingdom· Recruiting

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung condition that makes it difficult to breathe, often getting worse over time.

What is Lunsekimig?

Lunsekimig is the name of the new medicine being tested in this study. It's being investigated as a possible long-term treatment for COPD.

How long will I be in the study?

The study lasts for up to 100 weeks, which is about two years. This includes the time you're taking the medicine and a follow-up period.

Will I have to stop my usual COPD medicines?

For some participants, there's an optional part of the study that looks at reducing or stopping inhaled steroid medicines under close medical supervision. This would be discussed with you.

What if I change my mind about taking part?

You are free to leave the study at any time, for any reason, without it affecting your future medical care. Your participation is always voluntary.

How to find out more

Trial Transparency email recommended (Toll free for US & Canada)

contact-us@sanofi.com 800-633-1610 Official trial record

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