Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients with Moderate to Severe Hidradenitis Suppurativa (LOTUS)
This research study, called LOTUS, is looking into a new treatment, AVTX-009, for people who have moderate to severe hidradenitis suppurativa (HS). HS is a long-term skin condition causing painful lumps and abscesses. The main goal is to find out if AVTX-009 can significantly reduce these lumps and spots, making the condition better for people with HS. We'll also be checking how safe the medicine is. Participants will receive either the new medicine or a 'dummy' medicine (placebo), and nobody will know which they are getting until the study ends. We hope to see if this new medication could be a helpful option in the future.
At a glance
What is this study about?
This study is about a skin condition called hidradenitis suppurativa, often shortened to HS. People with HS get painful lumps, boils, and sometimes tunnels under their skin, usually in places where skin rubs together like the armpits or groin. It can be a really uncomfortable and challenging condition to live with.
We're testing a new medication called AVTX-009 to see if it can help people who have moderate to severe HS. The main thing we're looking for is whether this medicine can reduce the number of painful lumps and spots by a lot – specifically, by at least 75%. We also want to make sure that it doesn't cause more new problems in terms of abscesses or draining tunnels.
Alongside checking if the medicine works to improve your skin, we'll also be carefully checking its safety. This means looking for any side effects and how your body reacts to the treatment. By doing this study, we hope to find a new and effective treatment option that could make a real difference to people living with HS.
Key takeaways
- The study is testing a new medicine (AVTX-009) for moderate to severe hidradenitis suppurativa (HS).
- It aims to see if the medicine reduces painful lumps and spots by at least 75% and is safe.
- Participants will receive either AVTX-009 or a placebo (dummy medicine).
- Regular clinic visits, physical exams, and blood tests will be part of the study.
- The main treatment period is 16 weeks, with potential for longer follow-up.
- You can withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 or older. The study is open to both men and women.
Beyond these basic requirements, the study is looking for people who have been diagnosed with hidradenitis suppurativa (HS) that is considered moderate to severe. This means your HS is having a noticeable impact on your life and has certain levels of activity, which the study doctors will assess.
There might be other specific health conditions or medications that would mean you couldn't take part, to ensure the study is as safe as possible for everyone involved and that we can clearly see the effects of the new medicine. The study team will discuss all these details with you.
- Are you 18 years old or older?
- Do you have a diagnosis of moderate to severe hidradenitis suppurativa?
- Are you able to attend regular clinic visits?
- Are you comfortable with the possibility of receiving a placebo?
- Are you willing to undergo physical exams and blood tests?
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, you'll be assigned randomly to one of two groups: one group will receive the new medicine, AVTX-009, and the other will receive a 'dummy' medicine called a placebo. Neither you nor your study doctor will know which one you are getting – this is called a 'double-blind' study and helps us get the most accurate results.
During the study, you'll have regular visits to the clinic. These visits will involve various checks, such as physical examinations, blood tests, and vital signs (like blood pressure), to monitor your health and how your HS is responding. You'll also be asked about your pain levels and any changes you notice in your skin. The main part of the study where we're testing how well the medicine works will last for 16 weeks. However, the study might involve a longer period for follow-up to check on your health and any long-term effects. The study team will explain the exact schedule and total duration.
Potential risks and benefits
Locations (9)
- —France
- —Italy
- —Bulgaria
- —Greece
- —Slovakia
- —Germany
- —Czechia
- —Poland
- —Spain
Common questions
What is hidradenitis suppurativa (HS)?
HS is a long-term skin condition that causes painful lumps, boils, and sometimes tunnels under the skin, often in areas like the armpits or groin.
What is AVTX-009?
AVTX-009 is a new investigational medicine being tested to see if it can help improve hidradenitis suppurativa symptoms.
What does 'double-blind' mean?
It means neither you nor the study doctor will know if you're getting the active medicine or a 'dummy' medicine (placebo). This helps make the study results fair.
How long will I be in the study?
The main part of the study focusing on whether the medicine works lasts for 16 weeks, but the total time you're involved could be longer for follow-up.
Can I leave the study if I want to?
Yes, you are free to stop participating in the study at any time, for any reason, and it won't affect your regular 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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