Randomised, double-blind, placebo-controlled, Phase IIb/Phase III study to evaluate the efficacy and safety of spesolimab in patients with moderate to severe hidradenitis suppurativa. Lunsayil 1.
This research study, called Lunsayil 1, is looking into a new medicine called spesolimab for people living with moderate to severe hidradenitis suppurativa (HS). HS is a long-term skin condition. The main goal is to find out how well spesolimab works in reducing HS symptoms, like the number of swollen, painful bumps and abscesses. Researchers also want to check if the medicine is safe and if people can tolerate it well. To do this, the study uses a common research design where some participants will receive the active medicine, while others will receive a 'dummy' medicine called a placebo. Neither the patients nor their doctors will know who is getting which treatment. The study is in later stages (Phase IIb/III), meaning it's already shown some promise in earlier tests.
At a glance
What is this study about?
Hidradenitis suppurativa, often known as HS, is a long-term skin condition. It causes painful lumps, boils, and abscesses, usually in areas where skin rubs together, like the armpits or groin. These can sometimes break open, leading to scars and a lot of discomfort. Living with HS can be challenging and affect daily life.
This study is trying to find a new way to help people with HS. It's testing a medicine called spesolimab. Researchers want to see if this medicine can reduce the number of painful lumps and how severe they are. They also need to make sure the medicine is safe to use and that people don't have too many side effects.
To get clear answers, the study uses a special design: it's 'randomised,' meaning participants are put into groups by chance, like flipping a coin. It's also 'double-blind,' meaning neither the patients nor their study doctors will know who is getting the actual medicine and who is getting a dummy medicine (called a placebo). This helps ensure the results are fair and unbiased. The study is in its Phase II and III stage, which are important steps to see if the medicine should become widely available.
Key takeaways
- Tests a new medicine (spesolimab) for moderate to severe HS.
- Compares spesolimab to a 'dummy' medicine (placebo).
- Aims to reduce HS symptoms and check safety.
- You and your doctor won't know if you get active medicine or placebo.
- Open to adults aged 18 and over, both men and women.
- Participation is voluntary and you can leave at any time.
Who may be eligible?
To be considered for this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults can also take part.
Both men and women are welcome to participate in this research. The study is specifically looking for people who have been diagnosed with moderate to severe hidradenitis suppurativa.
There will be other detailed health checks to make sure the study medicine is right for you and won't interfere with other conditions or medicines you might be taking. A study doctor will go through all these requirements with you to see if you are a good fit.
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?
- Have you been diagnosed with moderate to severe hidradenitis suppurativa?
- Are you able to attend regular clinic appointments?
- Are you comfortable with the idea of potentially receiving a placebo?
What does participation involve?
If you decide to take part, you'll be assigned by chance to either receive the study medicine, spesolimab, or a placebo (a dummy medicine). You won't know which one you're getting, and neither will your study doctor. The medicine will likely be given as injections or infusions, but the exact schedule and number of visits to the clinic will be explained in full. You will have regular appointments where study staff will check your health, assess your HS symptoms, and record any side effects you might experience. This will involve physical examinations, blood tests, and questionnaires. The total duration of your participation, including follow-up visits after you stop taking the study medicine, will be clearly outlined by the research team.
Potential risks and benefits
Locations (17)
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- —UnverifiedPortugal
- —UnverifiedAustria
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedBelgium
- —UnverifiedSlovakia
- —UnverifiedGreece
- —UnverifiedBulgaria
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- —UnverifiedLithuania
Common questions
What is hidradenitis suppurativa (HS)?
HS is a long-lasting skin condition that causes painful lumps, boils, and abscesses, often in places where skin rubs together.
What is a placebo?
A placebo is a 'dummy' medicine that looks like the real medicine but contains no active ingredients. It helps researchers compare the new medicine's effects.
Why is this study 'double-blind'?
Being 'double-blind' means neither you nor your doctor will know if you're getting the study medicine or the placebo. This helps make the study results as fair and accurate as possible.
Can I still take my regular HS medicine while in the study?
The study team will tell you if you need to stop any of your current HS medicines. This is important to ensure the study results are clear and your safety is maintained.
What if I don't want to continue in the study?
You can leave the study at any time, for any reason. Your decision will not affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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