Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V2)

This research study is looking at a new medication called povorcitinib for adults who have nonsegmental vitiligo. Nonsegmental vitiligo is a condition where patches of your skin lose their colour. The main goals of this study are to find out how well povorcitinib works to help improve these skin patches and to check if it's safe to use. Some people in the study will receive povorcitinib, while others will receive a placebo, which looks like the medication but has no active ingredients. This helps researchers fairly compare the effects. If you're aged 18 or over and have vitiligo affecting a certain amount of your body and face, you might be able to take part.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Incyte Corporation

Enrolment target

450

Start

27 Nov 2023

Estimated completion

16 Mar 2027

NonSegmental Vitiligo

What is this study about?

This study is called STOP-V2 and it's focused on a skin condition called nonsegmental vitiligo. If you have vitiligo, it means patches of your skin lose their natural colour. This study aims to understand if a new medicine, povorcitinib, can help these patches improve and regain some colour. Researchers also want to make sure it's safe for people to use.

To do this, some people taking part will be given the actual medication (povorcitinib), while others will receive a 'placebo'. A placebo looks exactly like the medicine but doesn't have any active ingredients. This is a common and important way to test new treatments, as it helps compare the results fairly and see if the new medicine genuinely makes a difference. Neither you nor your doctor will know if you're taking the active medicine or the placebo during the study.

Because this is a 'Phase 3' study, it means the medication has already been tested in smaller groups of people and shown some promise. This larger study is a crucial step to confirm its benefits and safety before it could potentially be made available more widely. Taking part helps scientists learn more about vitiligo and find better ways to treat it, which can benefit many people in the future.

Key takeaways

This study is testing a new medicine, povorcitinib, for nonsegmental vitiligo.
It aims to check how well the medicine works and if it's safe.
Some participants will receive the medicine, others a placebo.
You must be 18 or older and have a specific type and amount of vitiligo.
You cannot use other vitiligo treatments during the study.
Your health will be closely monitored throughout the study.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a specific type of vitiligo called nonsegmental vitiligo. Your vitiligo needs to affect certain areas of your body and face, covering a measured amount of your skin. If you are accepted, you'll need to stop using any other creams or treatments for your vitiligo from the start of the study until after your last check-up.

There are also some reasons why you might not be able to join. For example, if you have other types of vitiligo or skin conditions, or if you've recently used certain treatments like light therapy or specific creams. If you've had surgery for vitiligo or if your vitiligo has significantly improved on its own recently, you also wouldn't be able to take part.

Also, you can't join if you are pregnant, planning to become pregnant, or breastfeeding. Men taking part must also be willing to avoid fathering children during the study. Certain health conditions, like serious heart problems, infections (such as TB, Hepatitis B or C, or HIV), or a history of specific blood issues or certain cancers, would also mean you couldn't participate. The study will also check your blood test results to make sure they are within a healthy range for taking part.

Quick self-check

Are you 18 years old or older?
Do you have nonsegmental vitiligo?
Does your vitiligo affect a certain amount of your body and face?
Are you willing to stop all other vitiligo treatments during the study?
Are you willing to avoid pregnancy (or fathering children) during the study?
Do you have any serious heart conditions, active infections, or have you recently had certain surgeries for vitiligo?

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

What does participation involve?

If you decide to take part in this study, you won't be able to use any other treatments for your vitiligo, whether they are creams, medicines, or procedures, from the time you start until your final check-up. This is important so that the researchers can clearly see the effects of the study medication.

Throughout the study, you'll have regular visits to the clinic where doctors and nurses will check your health, measure your vitiligo patches, and take blood samples. You will be given either the study medication (povorcitinib) or a placebo, which looks identical but has no active ingredients. You'll need to take this medication as instructed. The study will also include follow-up visits to monitor your health and any changes after you've finished taking the medication. The total time you'd be involved in the study would include these screening, treatment, and follow-up periods, but the exact duration isn't specified here.

Potential risks and benefits

Taking part in a study like this might offer you the potential benefit of trying a new medication that could improve your vitiligo, and you'll receive careful medical monitoring. However, there are potential risks, which will be fully explained by the study team. These could include side effects from the medication or the discomfort of study procedures like blood tests. It’s also possible the medication might not help your vitiligo, or you might receive the placebo. Your health and safety are paramount, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (86)

University of Alabama At Birmingham Hospital-Whitaker Clinic
Birmingham, United States
C2 Research Center, Llc
Montgomery, United States
First Oc Dermatology Research Inc
Fountain Valley, United States
Center For Dermatology Clinical Research, Inc
Fremont, United States
Marvel Clinical Research Llc
Huntington Beach, United States
Vitiligo & Pigmentation Institute of Southern California
Los Angeles, United States
Dermatology Research Associates
Los Angeles, United States
Clinical Trials Research Institute
Thousand Oaks, United States
Skin Care Research, Llc
Boca Raton, United States
Total Vein and Skin Llc
Boynton Beach, United States
Driven Research Llc
Coral Gables, United States
Florida Academic Centers Research and Education Llc
Coral Gables, United States

+74 more sites — see the official record for the full list.

Common questions

What is nonsegmental vitiligo?

It's a common type of vitiligo where patches of skin lose their colour on various parts of the body, often appearing in a symmetrical pattern.

What is a 'placebo'?

A placebo looks just like the real medicine but doesn't contain any active ingredients. It's used in studies to fairly compare the effects of the new medication.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor your study doctor will know whether you are receiving the povorcitinib or the placebo. This helps make the study results fair.

Can I continue my usual vitiligo treatments?

No, if you join the study, you must stop all other vitiligo treatments from the start until after your last study visit, so the new medicine's effects can be clearly seen.

What does Phase 3 mean for a study?

Phase 3 means the medicine has already shown promise in smaller studies. This larger study is to confirm how well it works and if it's safe on a bigger group of people.