Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
This study is investigating a new potential treatment, Lunsekimig, for adults aged 18 to 80 who have asthma that is considered high-risk. Participants will receive either Lunsekimig or a dummy treatment (placebo) alongside their usual asthma inhalers. The main goals are to see if Lunsekimig is effective in improving asthma control, how safe it is, and if people can tolerate it well. Those who aren't currently suitable for other advanced asthma medications (biologics) might be a good fit for this study. It's a randomised, double-blind study, meaning neither you nor the doctors will know who is getting the new drug. The study will last around 64 weeks, with the new treatment given for about 52 weeks.
At a glance
What is this study about?
This study is designed to explore a new potential medicine called Lunsekimig for adults who have asthma that is still quite troublesome despite their regular treatments. This type of asthma is sometimes called 'high-risk' because it means you might still have flare-ups or symptoms that affect your daily life.
The researchers want to find out if adding Lunsekimig to your current asthma care can make a difference. They will compare it to a 'placebo', which is a dummy treatment that looks just like the real medicine but contains no active drug. This helps them understand if any changes a participant experiences are truly due to Lunsekimig or if they might happen anyway.
The study also aims to check how safe Lunsekimig is and if people generally respond well to it without lots of side effects. It focuses on people who haven't yet tried other advanced asthma treatments often called 'biologics', offering a potential new option for managing their asthma.
Key takeaways
- This study is testing a new asthma medication called Lunsekimig.
- It's for adults (18-80) with asthma that's hard to control, who aren't on other advanced asthma drugs.
- You'll either receive Lunsekimig or a dummy treatment (placebo).
- The study lasts about 64 weeks with 18 visits to the clinic.
- The goal is to check how effective and safe Lunsekimig is.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be an adult between 18 and 80 years old with asthma that a doctor has diagnosed for at least a year. Your asthma should be considered mild to moderate, and you should have had at least one asthma flare-up in the year before the study began.
There are also some important reasons why you might not be able to join. For example, if you have other serious lung problems like COPD, or if you've recently had a severe asthma attack requiring emergency care or steroids within the last month. Also, if you've had a recent chest infection, or if you have certain types of infections or a weakened immune system, you wouldn't be able to take part.
The doctors will also check if you've had tuberculosis (TB) or if you're at high risk of getting it. They need to make sure you're generally healthy enough for the study, so if you have other serious health conditions that could interfere, you might not be eligible.
- Are you between 18 and 80 years old?
- Has a doctor diagnosed you with asthma for more than a year?
- Have you had at least one asthma flare-up in the past year?
- Do you currently have mild to moderate asthma (not too severe)?
- Do you currently have any serious lung diseases other than asthma?
- Have you recently had a severe asthma attack needing emergency treatment or steroids (within past month)?
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, the total time involved will be around 64 weeks, which is about a year and three months. During this time, you will receive the study medication (either Lunsekimig or the placebo) for about 52 weeks.
You will have a total of 18 visits to the clinic for check-ups and assessments. These visits will allow the medical team to monitor your health, how your asthma is doing, and if the study medication is safe and effective for you. They will likely involve questions about your symptoms, physical examinations, and possibly some breathing tests and blood tests.
Potential risks and benefits
Locations (230)
- The Center for Clinical Trials - Saraland- Site Number : 8400096Saraland, United States· Recruiting
- Chandler Clinical Research Trials- Site Number : 8400075Chandler, United States· Active not recruiting
- Epic Medical Research - Sun City- Site Number : 8400052Sun City, United States· Completed
- Tucson Clinical Research Institute- Site Number : 8400085Tucson, United States· Active not recruiting
- Ark Clinical Research- Site Number : 8400097Long Beach, United States· Recruiting
- Downtown L.A. Research Center- Site Number : 8400080Los Angeles, United States· Completed
- Carbon Health - North Hollywood - NoHo West- Site Number : 8400061North Hollywood, United States· Completed
- Carbon Health - San Mateo - Hillsdale Mall- Site Number : 8400062San Mateo, United States· Completed
- Stanford University Medical Center- Site Number : 8400108Stanford, United States· Recruiting
- Modena Allergy And Asthma- Site Number : 8400068Torrance, United States· Completed
- Howard University Hospital- Site Number : 8400107Washington D.C., United States· Recruiting
- Helix Biomedics- Site Number : 8400005Boynton Beach, United States· Recruiting
+218 more sites — see the official record for the full list.
Common questions
What is Lunsekimig?
Lunsekimig is a new medication being tested to see if it helps adults with asthma that is hard to control.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the study medication but doesn't contain any active drug. It helps researchers see if the new medicine is truly making a difference.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor the study doctors will know whether you are receiving Lunsekimig or the placebo until the study is over.
How long will I be in the study?
The study will last about 64 weeks (around 15 months), and you will be taking the study medication for approximately 52 weeks of that time.
Can I leave the study at any time?
Yes, you are free to stop participating in the study at any point, and your decision will not affect your ongoing medical care.
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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