Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma
This study, called a Phase 2 open-label extension study, is designed to see how safe and effective Lunsekimig (SAR443765) is over a longer period for adults with asthma. It's for people who have already completed an earlier study looking at this medication. If you've been in one of the previous studies and finished it, you might be offered the chance to continue taking Lunsekimig as part of this new, longer-term study. The study could last for up to 148 weeks (about 2 years and 10 months), with participants receiving the treatment for up to 144 weeks of that time. The main goal is to gather more information about how Lunsekimig works and if it's safe when used over a longer period.
At a glance
What is this study about?
You might have heard about clinical trials – they are how new medicines are tested to make sure they are safe and that they work. This particular study is for a new asthma medicine called Lunsekimig, also known as SAR443765. It's called a 'Phase 2' study, which means it's still in the earlier stages, focusing on whether the medicine is safe and if it has a positive effect, as well as finding the best dose.
What makes this study a bit different is that it's an 'open-label extension'. This means it's a follow-on study for people who have already taken part in another study where they received Lunsekimig. Instead of comparing it to a dummy treatment, everyone in this study will know they are receiving Lunsekimig. The 'extension' part means that if the medicine worked well for you and was safe in the first study, you might be able to continue taking it for a longer time.
The main reasons for doing this study are to check on the long-term safety of Lunsekimig and to see how effective it is over a longer period in managing asthma. Medicines are often tested for shorter periods initially, but it's important to understand their effects over many months or even years. This research helps doctors and scientists gather more complete information about Lunsekimig for people with asthma.
Key takeaways
- This study is for adults with asthma who have previously taken Lunsekimig.
- It aims to understand the long-term safety and effectiveness of Lunsekimig.
- The study can last for up to 148 weeks (nearly 3 years).
- You will know you are receiving Lunsekimig (it's an 'open-label' study).
- Regular monitoring and clinic visits will be part of your participation.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you must have already finished one of the previous Lunsekimig asthma studies (Study DRI16762 or ACT18301). You also need to be an adult, aged 18 or over.
Throughout the study, you'll need to be on a stable dose of your regular asthma medications, which usually include a moderate or high dose of inhaled steroids, along with other treatments you were using in the previous study, such as LABA, LAMA, LTRA, or methylxanthines. For women, you cannot be pregnant, breastfeeding, or planning to get pregnant during the study or for 8 weeks afterwards. Both men and women will need to use effective contraception if needed during this time.
You wouldn't be able to join if you developed a new health condition that your doctor thinks would make it unsafe for you to take part, or if you started smoking or vaping (including marijuana). You also can't have a history of serious addiction or be allergic to Lunsekimig or its ingredients.
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 asthma study?
- Am I 18 years old or older?
- Am I on stable doses of my regular asthma medications?
- Am I able and willing to attend regular study visits?
- Am I not currently smoking or vaping?
- Am I not pregnant or breastfeeding, if female?
What does participation involve?
If you are eligible and choose to take part, you would receive the study medication, Lunsekimig. The study could last for up to 148 weeks, which is nearly three years, though you would be taking the treatment for up to 144 weeks of that period. During this time, you would have regular visits to the study clinic where the study team would check your health, perform tests, and ask about your asthma symptoms and any side effects you might be experiencing. These assessments are important to track the safety and effectiveness of the medicine over time. The study will involve giving your consent to participate and following the study procedures as requested by the research team.
Potential risks and benefits
Locations (122)
- Chandler Clinical Research Trials- Site Number : 8400075Verified postcodeChandler, United States
- Tucson Clinical Research Institute- Site Number : 8400085Verified postcodeTucson, United States
- Allianz Research Institute - Aurora- Site Number : 8400026Verified postcodeAurora, United States
- Western States Clinical Research- Site Number : 8400014Verified postcodeWheat Ridge, United States
- Helix Biomedics- Site Number : 8400114Verified postcodeBoynton Beach, United States
- Beautiful Minds Clinical Research Center- Site Number : 8400049Verified postcodeCutler Bay, United States
- Qway Research - Hialeah- Site Number : 8400015Verified postcodeHialeah, United States
- Clintex Research Group - Miami - Southwest 27th Avenue- Site Number : 8400048Verified postcodeMiami, United States
- High Quality Research- Site Number : 8400039Verified postcodeMiami, United States
- Innovations Biotech- Site Number : 8400040Verified postcodeMiami, United States
- New Access Medical Center- Site Number : 8400043Verified postcodeMiami, United States
- Deluxe Health Center- Site Number : 8400045Verified postcodeMiami Lakes, United States
Common questions
What is Lunsekimig?
Lunsekimig is a new medicine being studied for adults with asthma. This study is looking at its long-term safety and how well it helps manage asthma.
Who can join this study?
This study is for adults with asthma who have already completed a previous study with Lunsekimig.
How long will I be in the study?
The study could last for up to 148 weeks (nearly three years), with you receiving the treatment for up to 144 weeks of that time.
Will I know if I'm getting the actual medicine?
Yes, this is an 'open-label' study, meaning everyone in the study will know they are receiving Lunsekimig.
What happens if I want to stop taking part?
You are free to leave the study at any time, for any reason, without it affecting your regular medical care.
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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