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 research is looking into a new treatment called lunsekimig for adults aged 40 to 80 years old who have Chronic Obstructive Pulmonary Disease (COPD). The study focuses on individuals whose COPD is not well-controlled by existing medications and who have a specific characteristic in their blood called an 'eosinophilic phenotype'. Researchers want to find out how effective lunsekimig is compared to a dummy treatment (placebo), and also check its safety and if people can tolerate it well. Participation involves up to 60 weeks, including initial checks, about 48 weeks of treatment with either lunsekimig or placebo given as an injection under the skin, and an 8-week follow-up period to see how you're doing after the treatment ends.
At a glance
What is this study about?
This study is a clinical trial, which means it's a careful way researchers test new treatments to see if they work and are safe. It's looking at a new medication called lunsekimig for people living with Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung condition that makes it hard to breathe, often causing coughing, wheezing, and shortness of breath. This particular study is for people whose COPD symptoms aren't fully controlled by their usual medications.
The study is focusing on a specific group of people with COPD who have what's called an 'eosinophilic phenotype'. This just means they have higher levels of certain white blood cells called eosinophils in their blood, which can be linked to inflammation in the lungs in some people with COPD. The researchers hope that by targeting this specific characteristic, lunsekimig might be a more effective treatment for these individuals.
Participants will be given either lunsekimig or a placebo (a dummy treatment that looks like the real medicine but contains no active drug). This allows researchers to accurately compare the effects of the new medicine against no active treatment. The main goals are to see if lunsekimig can help improve COPD symptoms, reduce flare-ups, and if it's safe to use and well-tolerated by patients.
Key takeaways
- This study tests a new medicine for COPD not fully controlled by current treatments.
- It's for adults aged 40-80 with a specific 'eosinophilic' type of COPD.
- You'll receive injections of either the new medicine or a dummy treatment.
- The study lasts up to 60 weeks, with regular clinic visits.
- Close medical monitoring is provided throughout your participation.
- You can stop participating at any time without affecting your usual care.
Who may be eligible?
To join this study, you generally need to be an adult between 40 and 80 years old with a diagnosis of COPD for at least one year. Your COPD should not be fully controlled by your current medications, and you should have had at least two moderate or one severe COPD flare-up in the past year. You also need to have been on a specific combination of COPD medicines (usually three different types) for at least 12 weeks and have a certain level of 'eosinophils' in your blood. You should also have a history of smoking for at least 10 years, even if you've stopped.
There are also some reasons why you wouldn't be able to join. For example, if you have asthma (including childhood asthma) or another significant lung disease not related to your COPD. You also can't be on high levels of long-term oxygen therapy. Other reasons include certain serious medical conditions, a history of cancer, or if you're taking specific long-term medications or had particular biologic treatments recently. The research team will carefully check all your medical history to make sure the study is right and safe for you.
- Are you between 40 and 80 years old?
- Do you have a doctor-diagnosed COPD for at least one year?
- Do your current COPD medications not fully control your symptoms?
- Have you had at least two moderate or one severe COPD flare-up in the past year?
- Are you currently on triple therapy (three specific COPD medicines)?
- Do you *not* have asthma or another major lung disease 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 in this study, it will involve several stages over a total of up to 60 weeks. First, there's a 'screening' period of up to 4 weeks where doctors will do tests to see if you're suitable for the study. If you qualify, you'll then enter the main 'treatment' period, which lasts for about 48 weeks. During this time, you'll receive injections under your skin (called subcutaneous injections) of either the study medication (lunsekimig) or a placebo, which is a dummy medication with no active drug. You won't know which one you're receiving.
Throughout the treatment period, you'll have regular visits to the clinic for check-ups, assessments, and to receive your medication. These appointments will allow the doctors to monitor your health, how your COPD is responding, and to check for any side effects. After the 48 weeks of treatment, there will be a 'follow-up' period of about 8 weeks where the study team will continue to monitor your health and well-being after you've finished receiving the study medication. All travel and parking associated with your study visits will be covered.
Potential risks and benefits
Locations (206)
- University of Alabama at Birmingham- Site Number : 8400003Birmingham, United States· Recruiting
- Tucson Clinical Research Institute- Site Number : 8400006Tucson, United States· Recruiting
- Inglewood Clinical- Site Number : 8400074Inglewood, United States· Recruiting
- Ark Clinical Research- Site Number : 8400113Long Beach, United States· Recruiting
- Alliance Clinical - West Hills- Site Number : 8400067Los Angeles, United States· Recruiting
- California Medical Research Associates - Northridge- Site Number : 8400089Northridge, United States· Recruiting
- Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005Boulder, United States· Recruiting
- Critical Care Pulmonary & Sleep Associates- Site Number : 8400081Lakewood, United States· Recruiting
- Howard University Hospital- Site Number : 8400080Washington D.C., United States· Recruiting
- Finlay Medical Research - Greenacres- Site Number : 8400107Greenacres City, United States· Recruiting
- Direct Helpers Research Center- Site Number : 8400057Hialeah, United States· Recruiting
- Pulmonary Specialists of the Palm Beaches- Site Number : 8400017Loxahatchee Groves, United States· Recruiting
+194 more sites — see the official record for the full list.
Common questions
What is 'eosinophilic phenotype'?
It refers to having a higher level of certain white blood cells called eosinophils in your blood, which can be a sign of a particular type of inflammation in the lungs for some people with COPD.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real study medication but doesn't contain any active drug. It helps researchers compare the true effects of the new medicine.
How will I receive the study medication?
The study medication, or placebo, will be given as an injection just under your skin, called a 'subcutaneous' injection, at the clinic.
Will I still take my regular COPD medicines?
Yes, you generally need to be on stable triple therapy (three specific types of COPD medicines) for a certain period before joining, and you will continue your usual care alongside the study medication.
How long does the study last?
The total duration of participation in the study, from initial screening to final follow-up, will be up to 60 weeks (about 14 months).
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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