Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype
This study is looking for adults aged 40 to 80 with a specific type of Chronic Obstructive Pulmonary Disease (COPD) that isn't fully controlled by their usual medicines. We're testing a new treatment called lunsekimig against a 'dummy' medicine (placebo) to see if it can improve symptoms, lung function, and reduce flare-ups. We also want to understand any side effects. Participants will receive injections under the skin over about 48 weeks, with a total study time of up to 60 weeks. This research aims to find better ways to manage COPD for those who need more help.
At a glance
What is this study about?
This study is designed for people who have Chronic Obstructive Pulmonary Disease, or COPD, which isn't responding enough to their current treatments. COPD makes it hard to breathe because of damage to the lungs, often caused by smoking. For some people with COPD, their condition is linked to a specific type of white blood cell called eosinophils. This study focuses on people with this particular type of COPD.
The main goal is to find out if a new medicine, lunsekimig, can help people with this kind of COPD breathe better, have fewer flare-ups, and generally feel more in control of their condition. We also want to make sure the medicine is safe and if any side effects are mild or manageable.
To do this, we'll compare lunsekimig to a 'placebo' – which looks exactly like the study medicine but contains no active drug. This helps us understand if any improvements are genuinely from the new medicine or if they might happen anyway due to other factors. Finding effective new treatments is really important for people living with COPD.
Key takeaways
- New medicine (lunsekimig) for specific COPD type.
- Compares lunsekimig to a dummy medicine (placebo).
- Study lasts up to 60 weeks, with 48 weeks of treatment.
- Involves regular injections under the skin.
- Aims to improve breathing, reduce flare-ups, and assess safety.
Who may be eligible?
This study is looking for men and women between the ages of 40 and 80 who have been diagnosed with COPD for at least one year. Your COPD should not be fully controlled by your current medicines, even if you are on a combination of three different types of inhalers.
To be considered, you should have a history of smoking for at least 10 'pack-years' (your doctor can explain this), and your doctor would need to confirm that your COPD has a specific feature called an 'eosinophilic phenotype' using a blood test. You also need to have had problems with your COPD getting worse at least twice, or one severe worsening, in the past year. There are also specific requirements about your lung function tests and body weight.
However, you wouldn't be able to join if you also have asthma or a serious lung disease other than COPD. Likewise, if you need a lot of extra oxygen at home, have had certain cancers, tuberculosis, or other unstable health conditions, or are taking certain other medications, you would not be eligible to take part.
- Are you between 40 and 80 years old?
- Have you been diagnosed with COPD for at least a year?
- Do you use three different inhalers for your COPD?
- Have you had at least two moderate or one severe COPD flare-up in the last year?
- Do you not have asthma or another serious lung illness besides COPD?
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, your total involvement in the study could last up to 60 weeks. This is split into a few main stages:
First, there's a 'screening period' which lasts up to 4 weeks. During this time, you'll have various tests and health checks to see if the study is right for you and if you meet all the requirements.
If you're eligible, you'll then enter the 'treatment period', which lasts for about 48 weeks. During this time, you will receive regular injections under your skin. You'll either get the study medicine, lunsekimig, or a placebo (a dummy medicine) – you won't know which one you're receiving. You'll have regular visits to the clinic for these injections, health checks, and to see how you're responding to the treatment.
After the treatment period, there will be a 'follow-up period' of about 8 weeks. This is to monitor your health after you've stopped receiving the study treatment. Throughout the study, you'll have regular assessments, which might include lung function tests, blood tests, and questionnaires about your symptoms and how you're feeling.
Potential risks and benefits
Locations (196)
- Chandler Clinical Research Trials- Site Number : 8400025Chandler, United States· Recruiting
- Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114Phoenix, United States· Recruiting
- Epic Medical Research - Surprise- Site Number : 8400096Surprise, United States· Recruiting
- IMAX Clinical Trials- Site Number : 8400109La Palma, United States· Recruiting
- Long Beach Research Institute- Site Number : 8400027Long Beach, United States· Recruiting
- Downtown L.A. Research Center- Site Number : 8400009Los Angeles, United States· Recruiting
- Newport Native MD- Site Number : 8400003Newport Beach, United States· Recruiting
- Paradigm Research - Redding- Site Number : 8400108Redding, United States· Recruiting
- Amicis Research Center - Valencia- Site Number : 8400119Valencia, United States· Recruiting
- Helix Biomedics- Site Number : 8400065Boynton Beach, United States· Recruiting
- Beautiful Minds Clinical Research Center- Site Number : 8400017Cutler Bay, United States· Recruiting
- Eastern Medical Group Research- Site Number : 8400020Fort Myers, United States· Recruiting
+184 more sites — see the official record for the full list.
Common questions
What exactly is 'eosinophilic phenotype' COPD?
This means your COPD has a specific pattern where certain white blood cells called eosinophils are higher than usual in your blood. This can suggest your COPD might respond differently to treatments.
What's the difference between lunsekimig and placebo?
Lunsekimig is the new medicine being tested. Placebo is a 'dummy' medicine that looks exactly like lunsekimig but doesn't contain any active drug. This helps researchers fairly compare the new medicine's effects.
Will I know if I'm getting the actual medicine or the placebo?
No, during the study, neither you nor your study doctor will know whether you are receiving lunsekimig or the placebo. This is standard practice in clinical trials to ensure unbiased results.
How will the medicine be given?
The medicine will be given as injections under the skin, similar to a jab you might get at the doctor's office, at regular intervals during the treatment period.
What happens if my COPD gets worse during the study?
Your health will be closely monitored throughout the study. If your COPD or any other health issue worsens, the study doctors will provide appropriate care and decide if you should continue in the study.
How to find out more
Trial Transparency email recommended (Toll free for US & Canada)
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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