Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

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 is looking at a new oral medicine, Povorcitinib, for people aged 18 and over who have moderate to severe hidradenitis suppurativa (HS). HS is a long-term skin condition. The study is designed to see if Povorcitinib can help reduce HS symptoms, ease pain, and improve overall well-being and daily life compared to a placebo (a tablet with no active medicine). Participants will be randomly assigned to receive either the new medicine or the placebo. Researchers will carefully check how well the medicine works and if there are any side effects over several months. This is a common way to test new medicines to make sure they are safe and effective.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Incyte Corp.

Enrolment target

291

Start

12 May 2023

Hidradenitis Suppurativa

What is this study about?

This clinical trial is exploring a new potential treatment for people living with hidradenitis suppurativa, often shortened to HS. HS is a challenging skin condition that causes painful lumps, boils, and sometimes tunnels under the skin, most commonly in areas where skin rubs together, like the armpits or groin. This study focuses on people who have moderate to severe forms of HS.

The new medicine being tested is called Povorcitinib. Researchers want to find out if this medicine can reduce the symptoms of HS, like the number of painful lumps, and also improve how people feel day-to-day, including their pain levels and overall quality of life. To do this, some participants will receive Povorcitinib, while others will receive a placebo – a dummy pill that looks exactly like the real medicine but contains no active ingredients. This is a standard and fair way to understand if the new medicine is truly effective, rather than any improvement being due to other factors.

The study is designed to see how many people show a significant improvement in their HS, including a reduction in flares and pain, after 12, 24, and 54 weeks. They will also look at how the medicine affects everyday life, such as tiredness and skin-related quality of life. The aim is to gather a lot of information to determine if Povorcitinib could be a safe and helpful new option for people with HS.

Key takeaways

This study is testing a new oral medicine called Povorcitinib for moderate to severe HS.
It compares Povorcitinib to a dummy pill (placebo) to see how well it works and if it's safe.
Participation involves regular clinic visits and health assessments over many months.
The goal is to reduce HS symptoms, lessen pain, and improve daily life.
You will be closely monitored by medical professionals if you take part.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 years or older. The study is open to both men and women.

The main requirement is that you have a diagnosis of hidradenitis suppurativa (HS) that is considered moderate to severe. This assessment will be made by the study doctors after a thorough check-up.

There will also be other specific medical criteria that the study team will discuss with you. These are in place to ensure your safety and that the study results are as clear and accurate as possible. It's important to talk to the study team or your own doctor to see if this trial might be suitable for you.

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.

Am I 18 years old or older?
Do I have a diagnosis of moderate to severe hidradenitis suppurativa (HS)?
Am I able to take oral tablets?
Am I willing to attend regular clinic visits over a potentially long period?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned by chance (like flipping a coin) to receive either the new medicine, Povorcitinib, or a placebo (a dummy pill). You will not know which you are receiving, and neither will the study doctors – this is called 'double-blind'. Both the medicine and the placebo are given as oral tablets.

Your participation will involve regular visits to the study clinic over several months. At these appointments, the study team will monitor your HS symptoms, assess any pain you might be experiencing using questionnaires, and ask about your general well-being and how your skin condition is affecting your daily life. They will also count specific skin lesions, such as abscesses, inflammatory nodules, and draining tunnels.

These assessments will happen at different points, including after 12, 24, and 54 weeks. The study will continue for an extended period, meaning your involvement could last for over a year to see the long-term effects of the treatment. You will have regular checks to make sure you are tolerating the treatment well and to monitor for any side effects.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new medicine before it's widely available, and close medical monitoring. You might find your HS symptoms improve, or your pain lessens. However, there's no guarantee the treatment will work for you, especially if you receive the placebo. All medicines carry potential risks, such as side effects, which will be carefully explained to you by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Poland
—
Unverified
Germany
—
Unverified
Bulgaria
—
Unverified
France
—
Unverified
Denmark
—
Unverified
Italy
—
Unverified
Spain

Common questions

What is hidradenitis suppurativa (HS)?

HS is a long-term skin condition causing painful lumps and abscesses, often in areas like the armpits or groin. It can be challenging to manage, and researchers are always looking for better treatments.

What is Povorcitinib?

Povorcitinib is a new medicine being tested as a potential treatment for moderate to severe HS. It's currently in clinical trials to see if it's safe and effective.

What does 'double-blind' mean?

Double-blind means neither you nor the study doctors will know whether you are receiving the active medicine (Povorcitinib) or a placebo (a dummy pill with no active ingredient). This helps ensure fair and accurate study results.

How long will I be in the study?

The study involves initial assessments at 12, 24, and 54 weeks, and there's an extended period. This means your participation could last for over a year to fully understand the effects of the treatment.

Can I stop participating if I want to?

Yes, you are completely free to leave the study at any time, for any reason, without needing to explain why. Your decision will not affect your future medical care.