A randomized Phase 2, double-blind, placebo-controlled, parallel-group, 2-arm study to assess the efficacy, safety, and tolerability of subcutaneous lunsekimig in adult participants with chronic rhinosinusitis with nasal polyps (CRSwNP)
This research study is for adults who have a long-lasting condition called chronic rhinosinusitis with nasal polyps (CRSwNP). This condition causes a stuffy nose and growths inside the nose. The study wants to find out if a new medicine called lunsekimig can help improve these symptoms and reduce the polyps. Participants will receive either lunsekimig or a dummy medicine (placebo), along with a standard nasal spray called Mometasone. Doctors will check if the new medicine works, how safe it is, and if people can tolerate it well. The study aims to offer a new way to help people who struggle with this condition.
At a glance
What is this study about?
This clinical trial is looking deeper into a health problem called chronic rhinosinusitis with nasal polyps, often shortened to CRSwNP. This is a condition where the lining of your nose and sinuses (the air-filled spaces behind your cheekbones and forehead) become inflamed for a long time. This inflammation can lead to the growth of soft, non-cancerous lumps inside your nose called nasal polyps, which can make it hard to breathe, reduce your sense of smell, and cause a constant stuffy or blocked nose.
The main goal of this study is to test a new medicine called lunsekimig. Researchers want to see if this medicine can shrink nasal polyps and make CRSwNP symptoms better. They also want to understand if lunsekimig is safe to use and if people can take it without too many side effects. This is a 'Phase 2' trial, which means it's an important early step in testing new medicines to see if they are promising enough to continue into larger studies.
To get a clear picture, some participants will receive the new medicine, while others will get a 'placebo' – a dummy medicine that looks the same but contains no active drug. This helps doctors see if any improvements are genuinely due to lunsekimig. All participants will also use an existing nasal spray called Mometasone. By carefully comparing the groups, researchers hope to learn if lunsekimig could become a new treatment option for people living with nasal polyps.
Key takeaways
- This study is testing a new medicine (lunsekimig) for adults with nasal polyps.
- It aims to see if lunsekimig can shrink polyps and reduce symptoms like a stuffy nose.
- Participants will receive either lunsekimig or a dummy medicine, plus a standard nasal spray.
- The study will check both how well the medicine works and if it's safe.
- Your health will be closely monitored throughout the study.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or over. Both men and women can take part. The study is specifically looking for people who have been diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP).
There will be other specific health requirements that the study doctors will check to make sure the study is a good fit for you and that it's safe for you to participate. For example, they'll want to review your medical history and current health status.
It's important to have an open conversation with the study team if you're interested. They can explain all the detailed rules for joining and help you understand if you meet them.
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 18 years old or older?
- Do you have a diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP)?
- Are you able to attend regular study visits?
- Are you willing to potentially receive a dummy medicine?
- Are you comfortable with injections under the skin?
What does participation involve?
If you decide to take part in this study, you would be asked to attend regular visits at the study clinic. During these visits, doctors and nurses would perform various checks. These might include looking inside your nose, asking about your symptoms, and possibly taking blood samples to check levels of the study medicine and to see if your body is reacting to it. You would also have scans like CT scans to look at your sinuses and polyps.
You would receive either the new study medicine, lunsekimig, or a dummy medicine (placebo) as an injection under your skin. You would also use a standard nasal spray called Mometasone. You would need to keep track of your symptoms and how you're feeling. The study team will explain exactly what's involved in each visit and how long the study will last for you, including any follow-up after you stop taking the study medicine.
Potential risks and benefits
Locations (3)
- —UnverifiedBulgaria
- —UnverifiedPoland
- —UnverifiedBelgium
Common questions
What are nasal polyps?
Nasal polyps are soft, non-cancerous growths that can appear inside your nose or sinuses, often linked to long-term inflammation.
What is chronic rhinosinusitis with nasal polyps (CRSwNP)?
It's a long-lasting condition where the lining of your nose and sinuses is inflamed, leading to symptoms like a blocked nose, loss of smell, and nasal polyps.
What does 'double-blind' mean?
It means neither you nor your study doctor will know if you are receiving the new medicine or the dummy medicine. This helps ensure fair results.
What is a placebo?
A placebo is a 'dummy' medicine that looks like the real thing but has no active drug. It helps researchers see if the actual medicine truly works.
Will I still get my usual treatment?
You will be given the study medicine or placebo along with a standard nasal spray (Mometasone). The study team will discuss all treatments with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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