A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Assess Efficacy and Safety of Zasocitinib in Moderate to Severe Hidradenitis Suppurativa
This research study is looking into a new medication, Zasocitinib, for individuals suffering from moderate to severe Hidradenitis Suppurativa (HS). HS is a long-term skin condition causing painful bumps and sores. The main goal is to find out if Zasocitinib can significantly reduce the number of these spots and make participants feel better after 16 weeks. They'll also be checking for any side effects. This is a 'Phase 2' study, which means it's an early stage of testing where scientists learn more about how well a new treatment works and if it's safe for people. Participants will be compared to a group receiving a 'dummy' treatment (placebo) to see if Zasocitinib is truly effective. The study aims to improve treatments available for HS.
At a glance
What is this study about?
This study is looking into a new medicine called Zasocitinib for people who have Hidradenitis Suppurativa, often shortened to HS. HS is a skin condition that can cause painful lumps, boils, and abscesses, usually in places where skin rubs together, like the armpits or groin. These can be quite severe, and finding effective treatments is very important.
In this study, researchers want to see if Zasocitinib can help reduce these painful lumps and sores. They will be looking closely at how many are visible after 16 weeks of treatment. They also want to understand if the new medicine causes any side effects. This is an important step in developing new treatments for HS, as finding options that work well and are safe is crucial for improving the lives of those with this condition.
This study is called a 'Phase 2' trial. This means it's an early stage of testing. At this stage, doctors are mainly exploring how effective the treatment is and paying close attention to its safety. Knowing how a new medicine performs in these early stages helps decide if it should be studied in even larger groups of people. Participants will receive either the new medicine or a dummy treatment (placebo) to fairly compare the results.
Key takeaways
- This study is testing a new medication (Zasocitinib) for moderate to severe Hidradenitis Suppurativa (HS).
- It's a 'Phase 2' trial, meaning doctors are exploring how well it works and its safety.
- The main goal is to see if the medication reduces HS symptoms after 16 weeks.
- Participants will receive either the new medicine or a dummy pill (placebo).
- Both men and women aged 18 and older can be considered.
- Your health and safety are monitored closely throughout the study.
Who may be eligible?
This study is looking for adult volunteers, 18 years old or older. Both men and women are welcome to take part.
You would be considered for this study if you have been diagnosed with moderate to severe Hidradenitis Suppurativa.
The research team will have a more detailed list of criteria to make sure the study is right for you and that they can get clear results. They will discuss these with you if you are interested.
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 moderate to severe Hidradenitis Suppurativa?
- Are you able to attend regular clinic visits for appointments and assessments?
- Are you willing to potentially receive either the new study medication or a placebo?
What does participation involve?
If you decide to join this study, you would be taking either the new medication, Zasocitinib, or a 'dummy' pill called a placebo. You wouldn't know which one you're getting, and neither would the study team, to make sure the results are fair.
You would attend regular visits to the clinic over a period of 16 weeks. At these visits, the study doctors would carefully check your Hidradenitis Suppurativa symptoms, such as counting the number of lumps and sores you have. They would also ask you how you're feeling and monitor you for any side effects. After the 16 weeks, there would likely be some follow-up visits to ensure your safety and track any longer-term effects. The total duration of your involvement could extend beyond the 16-week treatment period, including follow-up assessments.
Potential risks and benefits
Locations (4)
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- —UnverifiedGermany
Common questions
What is Hidradenitis Suppurativa (HS)?
HS is a long-term skin condition that causes painful lumps, boils, and abscesses, often in areas like the armpits or groin.
What does 'Phase 2 trial' mean?
It's an early stage of testing a new medicine where doctors learn more about how well it works and if it's safe for people.
What is a placebo?
A placebo is a 'dummy' pill that looks just like the study drug but contains no active medicine. It helps researchers fairly compare results.
Will I know if I'm getting the new medicine or the placebo?
No, neither you nor the study team will know during the main part of the study. This is called 'double-blind' and helps ensure fair results.
How long would I be in the study?
The main treatment period is 16 weeks, but your total involvement, including follow-up, could be longer.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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