INCB 18424-319: A phase 3, double-blind, randomised, vehicle-controlled, efficacy and safety study of ruxolitinib cream in participants with Purigo Nodularis. Topical ruxolitinib evaluation in Prurigo Nodularis (TRuE-PN1)
This research study is called TRuE-PN1 and is looking into a new cream to treat Prurigo Nodularis. This is a skin condition that causes extremely itchy bumps. The study aims to find out if a cream containing a medicine called ruxolitinib is better at reducing itch and improving the skin compared to a plain cream without the medicine. This is a 'Phase 3' study, meaning it's one of the final steps to confirm if the new treatment is safe and effective before it can potentially be made widely available. We'll be looking to see if patients experience a significant reduction in their itch and an overall improvement in their skin condition after 12 weeks of using the cream.
At a glance
What is this study about?
Imagine constantly having very itchy, bumpy skin – that's what life can be like for someone with Prurigo Nodularis. This condition can be really uncomfortable and impact daily life. Scientists are always working to find better ways to help people manage their conditions, and this study is doing just that for Prurigo Nodularis. It's designed to test a new cream containing a medicine called ruxolitinib.
This study, officially known as TRuE-PN1, is a 'Phase 3' trial. This means it's a very important stage in testing a new treatment. At this point, the medicine has already been through earlier tests which suggested it might be helpful and safe. Now, we need to compare it against a 'dummy' cream (called a vehicle cream) to be sure it really works better than no active treatment at all. Neither you nor your study doctor will know whether you are using the active cream or the dummy cream, which helps make sure the results are as fair as possible.
The main goal is to see if the ruxolitinib cream can significantly reduce the itchiness that people with Prurigo Nodularis experience. Specifically, the study will check if there's a big improvement in itch by 12 weeks, as well as looking at how much the overall skin condition improves. We will also check if these improvements happen sooner, such as after 4 weeks or even just 7 days.
Key takeaways
- Tests a new cream (ruxolitinib) for itchy skin bumps caused by Prurigo Nodularis.
- Compares the new cream to a simple, plain cream.
- Aims to reduce itchiness and improve skin over 12 weeks.
- Open to adults aged 18 and over.
- Participation involves regular clinic visits and applying the study cream.
Who may be eligible?
To take part in this study, you must be at least 18 years old. There is no upper age limit, meaning older adults are very welcome to participate as well. The study is open to both men and women.
Since this study is specifically for Prurigo Nodularis, you would need to have been diagnosed with this condition by a doctor to be considered for participation. The healthcare team running the study will check your medical history and current health carefully to make sure the study cream is right for you and that you meet all the necessary health criteria.
It's important that your Prurigo Nodularis is active enough for us to properly assess if the cream is making a difference. The study team will explain all the specific requirements in detail and answer any questions you may have about whether you're a good fit.
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 18 years old or older?
- Do you have a diagnosis of Prurigo Nodularis?
- Are you able to attend regular clinic appointments?
- Are you willing to apply a cream to your skin as instructed?
What does participation involve?
If you decide to join this study, you will be given either the ruxolitinib cream or a plain 'dummy' cream to apply to your skin as instructed. You won't know which cream you're getting, and neither will your study doctor. You'll have regular visits to the study clinic over a period of 12 weeks. During these visits, the study team will ask you questions about your itchiness, examine your skin, and record how you're feeling overall. They might also take some measurements or samples, such as blood tests, to monitor your health and how the treatment is working. It's important to attend all scheduled appointments and follow the instructions carefully. After the 12-week treatment period, there will likely be some follow-up appointments to check on you.
Potential risks and benefits
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Common questions
What is Prurigo Nodularis?
It's a skin condition that causes very itchy, crusty bumps, often making people scratch a lot.
What is ruxolitinib cream?
It's a new cream being tested that contains an active medicine designed to help reduce the itch and improve the skin in Prurigo Nodularis.
What does 'Phase 3' mean for this study?
Phase 3 means this is one of the final stages of testing, where the cream is compared to a plain cream to confirm if it's truly safe and effective.
Will I know if I'm getting the actual medicine or a plain cream?
No, neither you nor your study doctor will know. This is called 'double-blind' and helps make the study results fair.
How long will I be in the study?
The main treatment period is 12 weeks, with regular visits, and possibly some follow-up appointments afterwards.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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