Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)

This study is investigating a new medication called povorcitinib for people who have prurigo nodularis. This is a skin condition that causes very itchy bumps and can be difficult to manage. The main goal of the study is to find out if povorcitinib can effectively reduce the intense itching and improve the skin lesions, while also checking for any side effects or safety concerns. Participants will either receive povorcitinib or a placebo (a dummy treatment) to compare their effects. This is a Phase 3 study, meaning it's a larger trial to confirm the findings from earlier stages. It's an important step in finding better treatments for prurigo nodularis.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Incyte Corporation

Enrolment target

346

Start

10 Oct 2024

Estimated completion

03 May 2027

Prurigo Nodularis

What is this study about?

Prurigo nodularis is a skin condition that causes very itchy, crusty bumps (nodules) on the skin. This can be really uncomfortable and can significantly affect a person's quality of life. Current treatments don't always work for everyone, so doctors and researchers are always looking for new and better ways to help people manage their symptoms.

This particular study is looking at a new medication called povorcitinib. It's designed to see if this new drug can help reduce the intense itching and improve the skin lesions caused by prurigo nodularis. The study will also carefully monitor for any side effects to make sure the medication is safe. Some participants will receive povorcitinib, while others will receive a placebo, which looks like the real medicine but doesn't contain any active drug. This allows researchers to compare the effects accurately.

By taking part in studies like this, volunteers help us understand if new treatments are effective and safe. This information is crucial for developing new medicines that could ultimately improve the lives of many people living with challenging conditions like prurigo nodularis.

Key takeaways

This study evaluates a new drug, povorcitinib, for prurigo nodularis.
It aims to reduce itching and skin lesions, and check safety.
Participants will receive either povorcitinib or a placebo.
It's for adults aged 18-75 with severe itchy bumps.
Previous treatments for PN must have been unsuccessful or unsuitable.
Careful monitoring and regular clinic visits are required.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old and have been diagnosed with prurigo nodularis for at least three months. Your itching must be quite severe, with an average itch score of 7 or higher out of 10 in the week before starting the study. You also need to have at least 20 itchy bumps on at least two different parts of your body (like both arms, both legs, or your body's trunk).

Additionally, you should have tried a previous treatment for your prurigo nodularis that either didn't work, caused too many side effects, or wasn't suitable for you. Both men and women can participate, but women must not be pregnant, breastfeeding, or planning to become so. Men must also agree not to father children during the study.

There are also some reasons why you might not be able to join. For instance, if your itching is caused by something other than prurigo nodularis, or if you have certain health conditions like a history of blood clots, serious heart problems, or certain infections like TB or HIV. If you've previously had problems with similar types of medication called JAK or TYK2 inhibitors, you also won't be able to take part. The study team will review all your health information carefully to make sure it's safe for you to participate.

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 between 18 and 75 years old?
Have you been diagnosed with prurigo nodularis for at least 3 months?
Is your itching severe (average score of 7 or more out of 10)?
Do you have at least 20 itchy bumps on different parts of your body?
Have previous treatments for your prurigo nodularis not worked well?
Are you not pregnant, breastfeeding, or planning to become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the new medication, povorcitinib, or a placebo, which looks identical but contains no active drug. You won't know which one you're receiving, nor will the study team. You'll need to attend regular visits to the clinic so the study team can check your health, assess your skin, and monitor your itching. They will also take blood and urine samples to check how you're responding to the treatment and to look for any side effects. You'll be asked to keep track of your itching levels at home. The exact number of visits and the total duration of the study will be explained in detail by the study team, but typically these studies involve several clinic visits over a period of months.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available and receiving careful medical monitoring. However, there are also potential risks, including side effects from the medication (whether povorcitinib or the placebo), and the possibility that the treatment may not work for you. The study procedures, like blood tests, also carry minor risks. You will be fully informed about all known risks before you agree to participate, and importantly, you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (119)

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

Medical Dermatology Specialists Phoenix
Verified postcode
Phoenix, United States
Investigate Md
Verified postcode
Scottsdale, United States
First Oc Dermatology Research Inc
Verified postcode
Fountain Valley, United States
Clinical Science Institute Clinical Research Specialists Inc
Verified postcode
Santa Monica, United States
Center For Clinical and Cosmetic Research
Verified postcode
Aventura, United States
Schweiger Dermatology
Verified postcode
Boca Raton, United States
Direct Helpers Research Center
Verified postcode
Hialeah, United States
Skin Care Research, Llc
Verified postcode
Hollywood, United States
Ziaderm Research, Llc
Verified postcode
Miami, United States
Nodal Medical Center, Llc
Verified postcode
Tampa, United States
Trueblue Clinical Research Moore Clinical Research, Inc McR Tampa Clinic Location
Verified postcode
Tampa, United States
Dermatology Specialists Research
Verified postcode
Louisville, United States

Common questions

What is prurigo nodularis?

It's a skin condition that causes very itchy, hard bumps or nodules to form on the skin.

What is povorcitinib?

Povorcitinib is an investigational drug being tested to see if it can help reduce itching and improve skin bumps in people with prurigo nodularis.

What's a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medication but doesn't contain any active drug. It helps researchers compare the true effects of the study drug.

What 'phase' is this study?

This is a Phase 3 study, which means it's a larger stage of testing to confirm the drug's effectiveness and safety in a wider group of people.

Can I still take my current medication for prurigo nodularis?

The study team will advise you on which medications you can and cannot take during the trial. It's often necessary to stop certain treatments while participating.