RecruitingPHASE3INTERVENTIONAL

Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

This research is a 'rollover' study, meaning it's designed for people who have successfully completed a previous Incyte study testing a medicine called povorcitinib for Hidradenitis Suppurativa (HS). If you participated in one of those trials and your doctor felt the treatment was safe and helped you, this study gives you the chance to continue taking povorcitinib. The main aim is to allow those who benefited to keep receiving the medication, ensuring their doctor believes it's still suitable and they can follow the study's requirements. This study is in Phase 3, which means the drug has already undergone significant testing for safety and effectiveness.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Incyte Corporation

Enrolment target

600

Start

28 Feb 2025

Estimated completion

28 Feb 2028

Hidradenitis Suppurativa (HS)

What is this study about?

This study is a special kind of research often called a 'rollover' study. It's specifically for people who have previously taken part in certain clinical trials sponsored by the company Incyte, where they were given a medicine called povorcitinib for a skin condition called Hidradenitis Suppurativa (HS). If you were in one of these earlier studies, and your doctor believes that povorcitinib helped your HS and you didn't have any serious side effects, then this study gives you the opportunity to keep receiving the treatment. It's a way to continue care for those who responded well to the drug.

The main reason for a rollover study like this is to give participants who have already found benefit from an investigational treatment the chance to continue with it. This is particularly important when the treatment has shown promise but isn't yet available to the public. It also helps researchers gather more information about the long-term effects and benefits of the drug in a group of people who have already tolerated it well.

This is a Phase 3 study, which means povorcitinib has already gone through earlier stages of testing to check its safety and how well it works. In this phase, researchers are usually looking at a larger group of people to confirm these findings and gather more detailed information before the drug might be considered for wider use. Participating means continuing to follow a set plan, taking the study drug, and attending regular check-ups with the research team.

Key takeaways

This study is for people who have already benefited from povorcitinib in a previous trial for HS.
It allows you to continue receiving the study drug.
Your doctor must confirm it's safe and beneficial for you to continue.
You will have regular check-ups to monitor your health and treatment.
This is a Phase 3 study, meaning the drug has undergone significant testing.
You can stop participating at any time.

Who may be eligible?

To join this study, you must have already completed a specific previous study (called a 'parent study') where you received the medicine povorcitinib for Hidradenitis Suppurativa. Your doctor in that previous study must have decided that the treatment was safe for you, you tolerated it well, and it provided you with a clear benefit. You also need to be able to understand and sign the consent form, and be willing to follow all the study instructions and attend appointments.

There are also some reasons why you wouldn't be able to join. For example, if you had to stop the treatment permanently in the parent study, or if you had to pause treatment due to safety concerns at the end of the parent study. You also can't have received certain other medications, like specific biological treatments or 'live' vaccines, within 28 days before starting this study, or plan to get a live vaccine during the study period.

Additionally, if you are pregnant, planning to become pregnant, or breastfeeding, you cannot participate. If you have a known severe allergy to povorcitinib or similar medicines, or if you are already in another clinical study with an experimental treatment, you would also not be able to join. Your study doctor will review all of these points to make sure this study is right for you.

Quick self-check

Have you already completed a specific previous Incyte-sponsored povorcitinib study?
Did your doctor in that study think povorcitinib helped your HS and you tolerated it well?
Are you able to follow study instructions and attend regular appointments?
Are you currently not pregnant, breastfeeding, or planning a pregnancy?
Have you avoided certain other medications or 'live' vaccines recently?
Are you not currently involved in another clinical study with an experimental treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will continue to receive the study drug, povorcitinib. You will need to take the medication as directed by the study team. You'll also have regular visits to the clinic so the doctors and nurses can check on your health and how the treatment is working. These visits will involve various tests and assessments, which might include blood tests, physical examinations, and questions about your HS symptoms and any side effects. You'll need to follow specific rules regarding avoiding pregnancy or fathering children during the study. The total length of the study will be explained by the research team, and it’s likely to be an ongoing extension of your previous participation.

Potential risks and benefits

The potential benefit of taking part is that you can continue to receive povorcitinib, a treatment that your previous study doctor felt was safe for you and helped your Hidradenitis Suppurativa. However, all medicines have potential risks, including side effects, and povorcitinib is still being studied. While a benefit means you tolerated the drug well previously, there's always a chance of new side effects arising. You will be closely monitored for any health changes. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (317)

Investigative Site US086
Birmingham, United States· Recruiting
Investigative Site US098
Montgomery, United States· Not yet recruiting
Investigative Site US004
Phoenix, United States· Recruiting
Investigative Site US047
Scottsdale, United States· Not yet recruiting
Investigative Site US124
Scottsdale, United States· Not yet recruiting
Investigative Site US115
Tucson, United States· Not yet recruiting
Investigative Site US113
Fayetteville, United States· Not yet recruiting
Investigative Site US009
Rogers, United States· Not yet recruiting
Investigative Site US076
Fountain Valley, United States· Recruiting
Investigative Site US077
Fremont, United States· Recruiting
Investigative Site US071
Huntington Beach, United States· Not yet recruiting
Investigative Site US020
Laguna Niguel, United States· Recruiting

+305 more sites — see the official record for the full list.

Common questions

What is a 'rollover' study?

It's a study that allows people who have already completed a previous trial for a specific condition and found the treatment helpful to continue receiving that treatment.

Will I take the same medicine as before?

Yes, this study is for continuing treatment with povorcitinib, the same medicine you received in the previous study.

How long will this study last?

The study team will let you know the expected duration, as it may vary. It's often an opportunity to continue treatment for an extended period.

What kind of appointments will I have?

You'll have regular visits for check-ups, physical exams, blood tests, and to discuss how you're feeling and how your HS is responding.

Can I stop taking part if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your future medical care.

How to find out more

Incyte Corporation Call Center (US)

medinfo@incyte.com 1.855.463.3463 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.