INCB 18424-320: A phase 3, double-blind, randomised, vehicle-controlled, efficacy and safety study of ruxolitinib cream in participants with Prurigo Nodularis. Topical ruxolitinib evaluation in Prurigo Nodularis (TRuE-PN2)
This study is looking for volunteers with Prurigo Nodularis, a skin condition causing very itchy bumps, to test a new cream called ruxolitinib. It's a Phase 3 trial, which means it’s one of the final stages to check if the new cream is truly effective and safe before doctors can prescribe it widely. Some participants will receive the ruxolitinib cream, while others will get a 'dummy' cream (called a vehicle cream) that looks and feels the same but contains no active medicine. This allows researchers to fairly compare how well the new cream works at reducing itchiness over 12 weeks. The main goal is to see if the cream can significantly improve itching levels.
At a glance
What is this study about?
This study, called TRuE-PN2, is investigating a new cream designed to treat Prurigo Nodularis. Prurigo Nodularis is a skin condition that causes extremely itchy, firm lumps to form on the skin. The constant itching can be very distressing and significantly affect a person's daily life.
The cream being tested contains a medicine called ruxolitinib. To properly understand if this new cream works, researchers will compare it to a 'vehicle cream'. This vehicle cream is exactly the same as the ruxolitinib cream in terms of its look, feel, and ingredients, but it doesn't contain the actual medicine. This comparison helps scientists determine if any improvements seen are definitely due to the ruxolitinib and not just the act of applying a cream.
The main aim of the study is to see if participants using the ruxolitinib cream experience a significant reduction in their itching after 12 weeks compared to those using the vehicle cream. They will also look at how quickly the itching improves, and if the overall appearance of the skin condition gets better. This type of study, called a Phase 3 trial, is a crucial step to confirm if a new medicine is safe and effective enough to be approved for wider medical use.
Key takeaways
- This study tests a new cream (ruxolitinib) for itchy skin lumps (Prurigo Nodularis).
- It compares the new cream to a 'dummy' cream to see if it reduces itching.
- The study is for adults over 18 with diagnosed Prurigo Nodularis.
- Participation involves applying cream and attending regular clinic visits.
- The main goal is to measure how much itching improves after 12 weeks.
Who may be eligible?
This study is looking for adults aged 18 years and older who have Prurigo Nodularis. Both men and women are welcome to take part.
To be eligible, you'll need to have a confirmed diagnosis of Prurigo Nodularis. This means a doctor will have looked at your skin condition and confirmed it's Prurigo Nodularis, not something else. The study will likely check other health factors too, to make sure it's safe for you to participate and that the results aren't affected by other conditions or medications you might be taking.
Keep in mind that even if you meet the age and condition requirements, there might be other specific criteria that determine if you can join. It's always best to discuss your individual situation with staff at the study site.
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 visits?
- Are you willing to apply a cream as instructed?
What does participation involve?
If you decide to take part in this study, you won't know whether you are receiving the active ruxolitinib cream or the 'dummy' vehicle cream; the doctors and study staff won't know either. You'll be asked to apply the cream to your affected skin areas regularly as instructed. Over the course of the study, you will have several visits to the clinic. During these visits, the study team will monitor your skin condition, assess your itching levels using a specific scale, and check your overall health and any side effects you might experience. These assessments will help record your progress and ensure your safety. The total duration of your participation in the study will be confirmed by the study team, but key measurements are taken at 4 and 12 weeks.
Potential risks and benefits
Locations (8)
- —UnverifiedAustria
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedBulgaria
- —UnverifiedGermany
- —UnverifiedDenmark
- —UnverifiedItaly
Common questions
What is Prurigo Nodularis?
It's a skin condition that causes very itchy, firm lumps on your skin, often leading to a cycle of itching and scratching.
What does 'double-blind' mean?
It means neither you nor the doctors treating you will know if you're getting the active cream or the dummy cream. This helps make the study fair.
What is a 'vehicle cream'?
It's a cream that looks and feels just like the study cream but doesn't contain any active medicine. It's used for comparison.
How long will I be in the study?
Key measurements are taken at 4 and 12 weeks, but the full duration of your participation will be explained by the study team.
Will I get paid to participate?
Payment or compensation for your time and travel will be discussed by the local study team if applicable.
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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