Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa

This study is about a new medicine called Povorcitinib for a skin condition known as hidradenitis suppurativa (HS). HS causes painful lumps under the skin. This particular study is for people who have already been taking Povorcitinib in an earlier study (called INCB 54707-301 or INCB 54707-302) for 54 weeks. The main goal is to check the long-term safety of Povorcitinib and to see how well it continues to work in managing HS symptoms over an extended period. By continuing to follow participants, researchers hope to gather more important information about this potential treatment.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Incyte Corporation

Enrolment target

617

Start

30 Jan 2024

Estimated completion

26 Dec 2026

Hidradenitis Suppurativa (HS)

What is this study about?

This study is looking at a new treatment called Povorcitinib for a skin condition known as hidradenitis suppurativa, or HS. HS can cause painful, deep lumps and scarring on different parts of the body. Finding effective long-term treatments for HS is very important for improving the lives of people with this condition.

This particular study is designed for people who have already taken part in one of two earlier studies (called INCB 54707-301 or INCB 54707-302). In those studies, participants received either Povorcitinib or a placebo (a dummy treatment) for 54 weeks. If you were in one of these previous studies and completed your treatment, this new study offers a chance to continue receiving Povorcitinib.

The main aim of this follow-up study is to understand the long-term safety of Povorcitinib. Researchers want to see if there are any side effects that might only show up after taking the medicine for a longer time. They also want to check how well Povorcitinib continues to help with HS symptoms and if its benefits last over many months.

Key takeaways

This study is for adults with moderate to severe HS.
It's a follow-up for those who completed an earlier Povorcitinib study.
The main goals are to check the medication's long-term safety and how well it keeps working.
Participation involves continued medication and regular clinic visits.
It's important to use contraception during the study if applicable.
You can stop participating at any time if you change your mind.

Who may be eligible?

This study is open to adults aged 18 and over, of any gender. To join, you must have successfully finished the entire 54-week treatment period of one of the earlier Povorcitinib studies (either INCB 54707-301 or INCB 54707-302).

You would also need to agree to use effective contraception if you are able to get pregnant or get someone pregnant. You should also be willing and able to follow all the study instructions and attend appointments.

However, you would not be able to join if taking part in the study could put your safety at risk. Also, if you are pregnant, planning to become pregnant, or breastfeeding, you would not be able to participate. The study team will discuss any other reasons why you might not be able to join.

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.

Have I completed the full 54 weeks of treatment in either the INCB 54707-301 or INCB 54707-302 study?
Am I 18 years old or older?
Am I willing to use contraception during the study (if I can become pregnant or get someone pregnant)?
Am I able and willing to attend all study appointments and follow instructions?
Am I not pregnant or breastfeeding, and not planning to become pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive the study medicine, Povorcitinib. You will have regular visits to the clinic where the study team will monitor your health, check for any side effects, and see how your HS symptoms are responding to the treatment. These visits will involve physical examinations, taking blood samples, and answering questions about your health and how you're feeling.

The study also requires you to agree to use contraception to prevent pregnancy during your time in the study. The total duration of your participation in this long-term study will be explained in detail by the study team, but it is an extension of the treatment you have already been receiving.

Potential risks and benefits

Taking part in a study like this may offer potential benefits, such as continuing to receive a treatment that could help manage your HS symptoms and getting close medical monitoring. However, there are also potential risks involved, mainly related to possible side effects of the medication, which the study team will explain fully. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (165)

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

Investigative Site US303
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Phoenix, United States
Investigative Site US240
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Scottsdale, United States
Investigative Site US307
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Fort Smith, United States
Investigative Site US214
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Rogers, United States
Investigative Site US315
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Laguna Niguel, United States
Investigative Site US223
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Los Angeles, United States
Investigative Site US222
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Oakland, United States
Investigative Site US226
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San Diego, United States
Investigative Site US309
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Clearwater, United States
Investigative Site US317
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Hialeah, United States
Investigative Site US306
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Hollywood, United States
Investigative Site US320
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Hollywood, United States

Common questions

What is hidradenitis suppurativa (HS)?

HS is a long-lasting skin condition that causes painful lumps, boils, and scarring, often in areas where skin rubs together like the armpits or groin.

What is Povorcitinib?

Povorcitinib is a new medicine being studied to see if it can help treat HS.

Why is this study only for people who were in earlier studies?

This study is a follow-up to see how safe and effective Povorcitinib is over a longer period, building on information from the first phase of studies.

Will I definitely get Povorcitinib if I join?

Yes, if you previously completed the treatment phase of the parent studies, this extension study aims to continue providing Povorcitinib.

What are 'long-term safety and efficacy'?

Long-term safety means checking for any side effects that might appear over many months or years. Efficacy means how well the medicine continues to work to treat your HS over time.