A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
This research study is looking into a new oral medicine called povorcitinib for people living with moderate to severe hidradenitis suppurativa (HS). HS is a long-term skin condition that causes painful lumps and boils. The study aims to find out if povorcitinib is safe and effective in reducing HS symptoms, pain, and how it impacts daily life, compared to a placebo (a pill with no medicine). Participants will take the medicine or placebo, and researchers will carefully check their progress, looking at how their skin clears up and how they feel. This is a "Phase 3" study, meaning it's a key step in seeing if povorcitinib could become a new treatment option.
At a glance
What is this study about?
This study is about a skin condition called hidradenitis suppurativa, often shortened to HS. HS is a chronic (long-lasting) condition that causes painful lumps, boils, and sometimes tunnels under the skin, usually in areas where skin rubs together, like the armpits or groin. It can be very uncomfortable and affect daily life. This research aims to understand if a new medicine called povorcitinib could be a helpful treatment for people with moderate to severe HS.
Normally, when a new medicine is developed, it goes through different stages of testing. This is a "Phase 3" study, which means it's one of the final and most important stages. Researchers want to confirm whether povorcitinib is both safe and effective when compared to a 'dummy' pill, called a placebo. By doing this, they can get a really clear picture of how the new medicine works.
Throughout the study, doctors and nurses will closely monitor how participants' HS changes, looking at things like how many lumps they have, how much pain they experience, and how the condition affects their quality of life. The goal is to see if povorcitinib can significantly help improve these aspects for people living with HS.
Key takeaways
- This study tests a new oral medicine (povorcitinib) for moderate to severe hidradenitis suppurativa (HS).
- It aims to see if the medicine is safe and helps reduce HS symptoms and pain.
- Participants will receive either the new medicine or a placebo (dummy pill).
- Regular clinic visits and health checks are part of being in the study.
- It's a Phase 3 trial, crucial for determining if the medicine could become a treatment option.
- You can stop participating at any time.
Who may be eligible?
To be part of this study, you generally need to be an adult, 18 years old or older. The study is open to both men and women.
It's specifically for people who have been diagnosed with moderate to severe hidradenitis suppurativa. This means your HS is causing significant issues and isn't just a very mild version of the condition.
There might be other specific health requirements or conditions that would make someone suitable or unsuitable for the study, which a doctor involved in the trial would discuss with you in detail.
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 generally able to attend regular clinic appointments?
- Are you comfortable potentially receiving a placebo (a non-active pill)?
- Are you willing to follow a specific treatment plan and undergo various assessments?
What does participation involve?
If you join this study, you would be randomly assigned to either receive the new medicine (povorcitinib) or a placebo (a pill that looks the same but contains no active medicine). Neither you nor your study doctor would know which you are receiving – this is to ensure the results are as fair as possible. You would take the tablets as instructed.
Your participation would involve regular visits to a clinic over a period of time, possibly up to 54 weeks (just over a year). During these visits, the study team would perform various assessments. These include checking your skin (counting lumps, nodules, and tunnels), asking about your pain levels and how HS affects your daily life, and taking blood samples. These checks help the researchers understand how the medicine is working and monitor your health carefully. The total duration of your involvement could be several months, determined by the study design.
Potential risks and benefits
Locations (9)
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedAustria
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedGreece
- —UnverifiedCzechia
- —UnverifiedNetherlands
Common questions
What is hidradenitis suppurativa (HS)?
HS is a long-term skin condition that causes painful lumps, boils, and sometimes tunnels, usually in areas where skin rubs together like the armpits or groin.
What is a 'Phase 3' study?
It's one of the final and most important stages of testing a new medicine. Researchers want to confirm it's safe and effective compared to a 'dummy' pill.
What is a placebo?
A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredient. It helps researchers fairly compare how well the new medicine works.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'double-blind' study. Neither you nor your study doctor will know who is getting the active medicine to keep the results unbiased.
How long would I be in the study?
Your participation could last for several months, potentially up to 54 weeks (just over a year), with regular clinic visits.
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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