Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Study
This research is an extension study for adults living with chronic rhinosinusitis with nasal polyps (CRSwNP), a condition that causes long-term inflammation of the nose and sinuses, often with growths called polyps. If you’ve already taken part in a previous study using a treatment called lunsekimig, this new study aims to check its safety, how well people tolerate it, and how effective it is over a longer period. Participants will continue to receive lunsekimig and a standard nasal spray. The study duration will be about 56 weeks, including 52 weeks of treatment and a short follow-up period, to understand the long-term effects of lunsekimig in managing this condition.
At a glance
What is this study about?
This study is designed for people who have chronic rhinosinusitis with nasal polyps (CRSwNP). This is a long-lasting condition where the lining of your nose and sinuses becomes inflamed, often leading to growths called nasal polyps. This can cause symptoms like a blocked nose, reduced sense of smell, and a runny nose. The study is particularly for adults who have already taken part in a previous clinical study looking at a new medicine called lunsekimig for this condition.
The main goal of this current study is to see how lunsekimig works over a longer period. Researchers want to understand its long-term safety – meaning are there any side effects that appear over time – and how well people tolerate it. They also want to check how effective it is in managing CRSwNP symptoms over many months, which is really important for developing new and better treatments.
By continuing to observe participants who have already started treatment with lunsekimig, scientists can gather valuable information that helps them understand the full picture of this new medicine. This kind of long-term information is crucial for deciding if a new treatment is suitable and safe for widespread use, ultimately aiming to improve the lives of people living with chronic rhinosinusitis with nasal polyps.
Key takeaways
- This is an extension study for adults with chronic rhinosinusitis with nasal polyps.
- It's for people who have already been in a previous study using lunsekimig.
- The study aims to check the long-term safety and effectiveness of lunsekimig.
- Participants will continue using lunsekimig and a mometasone furoate nasal spray.
- The study lasts approximately 56 weeks, including 52 weeks of treatment.
- Regular clinic visits will monitor health and treatment response.
Who may be eligible?
To join this study, you must be an adult who has already completed a previous study on lunsekimig for chronic rhinosinusitis with nasal polyps (CRSwNP). This means you would have finished all the treatment and follow-up visits in that earlier study as planned. You also need to be currently using a specific nasal spray called mometasone furoate.
It's important that you are willing and able to attend all the required study appointments and follow the study instructions. The research team will check if you meet all the necessary requirements before you can take part.
You cannot join if you've had a bad allergic reaction to lunsekimig or any of its ingredients in the past, or if your doctor thinks it's not safe for you. You also can't be in any other medical studies at the same time. If you experienced a serious side effect in the previous lunsekimig study that the doctors believe makes it risky for you to continue with the treatment, you would also not be able to join this extension study.
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.
- Have I completed a previous lunsekimig study for nasal polyps?
- Am I currently using mometasone furoate nasal spray?
- Am I an adult?
- Am I willing to attend all study visits and follow instructions?
- Have I ever had a severe allergic reaction to lunsekimig?
- Am I currently participating in any other medical studies?
What does participation involve?
If you decide to take part in this study, you will continue to receive the study medicine, lunsekimig, along with your regular mometasone furoate nasal spray. You will attend regular visits to the clinic so the study team can monitor your health, check your symptoms, and see how you are responding to the treatment. These visits will likely involve check-ups, answering questions about your health, and potentially some medical tests or examinations.
The treatment period in this study is planned to last for 52 weeks, which is almost a year. After the treatment period, there will be a follow-up period of about 4 weeks. So, in total, your participation in the study will last for approximately 56 weeks, which is a little over a year. The study team will provide you with all the necessary details about the schedule of visits and what each visit will involve.
Potential risks and benefits
Locations (24)
- Modena Allergy + Asthma- Site Number : 8400005Verified postcodeLa Jolla, United States
- Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003Verified postcodeRoseville, United States
- Treasure Valley Medical Research- Site Number : 8400002Verified postcodeBoise, United States
- Essential Medical Research- Site Number : 8400020Verified postcodeTulsa, United States
- McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400017Verified postcodeBellaire, United States
- Pharmaceutical Research & Consulting- Site Number : 8400004Verified postcodeDallas, United States
- ENT Associates of Texas - McKinne- Site Number : 8400014Verified postcodeMcKinney, United States
- Alamo ENT Associates- Site Number : 8400001Verified postcodeSan Antonio, United States
- Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400008Verified postcodeNorfolk, United States
- Investigational Site Number : 0320002Verified postcodeRosario, Argentina
- Investigational Site Number : 0320001Verified postcodeBuenos Aires, Argentina
- Investigational Site Number : 0320003Verified postcodeMendoza, Argentina
Common questions
What is chronic rhinosinusitis with nasal polyps (CRSwNP)?
It's a long-lasting condition causing inflammation in your nose and sinuses, often with growths called nasal polyps, which can block your nose and affect your sense of smell.
What is lunsekimig?
Lunsekimig is a medicine being studied for the treatment of chronic rhinosinusitis with nasal polyps. This study is looking at its long-term effects.
Why is this study important if I've already been in a lunsekimig study?
This study helps researchers understand the long-term safety and effectiveness of lunsekimig over many months, which is crucial for developing lasting treatments.
Will I take any other medication during the study?
Yes, you will continue to use lunsekimig and a standard nasal spray called mometasone furoate.
How long will I be in this study?
Your participation will last for about 56 weeks, which includes 52 weeks of treatment and 4 weeks of follow-up.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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