Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

18424-326: A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis

This research study is looking at a new cream called ruxolitinib for adults who have a skin condition called atopic dermatitis, also known as eczema. Specifically, it's for those with moderate eczema. Scientists want to find out how well this cream works to lessen eczema symptoms and itching, and if it's safe to use. To do this, they will compare it to a 'dummy' cream, which looks and feels the same but doesn't contain any active medicine. Participants will be chosen randomly to receive either the new cream or the dummy cream without knowing which one they are getting. The main goals are to see how many people have a significant improvement in their eczema after 8 weeks and how many notice a big reduction in their itching.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Incyte Corp.

Enrolment target

132

Start

23 Jul 2024

Atopic Dermatitis

What is this study about?

This study is about testing a new cream called ruxolitinib for people who have moderate atopic dermatitis, which is a common type of eczema. Eczema can make your skin itchy, red, and dry. The main purpose of this study is to see if this new cream is effective in improving these symptoms and if it's safe to use. This is a 'Phase 3b' study, which means it's one of the final stages of testing before a medicine might become widely available.

To make sure the results are fair, some people in the study will get the ruxolitinib cream, while others will get a 'vehicle' cream. The vehicle cream looks and feels exactly the same as the ruxolitinib cream, but it doesn't contain any medicine. Neither you nor your study doctor will know which cream you are using, which helps to get unbiased results. This is a common and important way to test new medicines.

Researchers will be looking at how much your eczema improves, how much your itching reduces, and your overall skin condition after 8 weeks. They'll use special scoring systems to measure these improvements. They will also keep a close eye on any side effects you might experience and how the cream affects your quality of life, sleep, and daily activities.

Key takeaways

This study is testing a new cream (ruxolitinib) for moderate eczema.
It aims to see how well it reduces eczema symptoms and itching.
Participants will get either the new cream or a dummy cream.
The study will last for at least 8 weeks, with regular check-ups.
Researchers will monitor how skin improves, itching, and quality of life.
All adults (18+) with moderate eczema are invited to consider if they meet other health criteria.

Who may be eligible?

To join this study, you need to be an adult, which means you must be 18 years old or older. Both men and women are welcome to take part.

You also need to have atopic dermatitis, or eczema, that is considered 'moderate.' The study doctors will carefully check your skin to make sure your eczema fits the study's requirements. This involves looking at how much of your body is affected and how severe your symptoms are.

There will be other specific health checks to make sure the study is safe for you and that you are suitable to participate. These checks help ensure that the study results are clear and that all participants are treated safely.

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?
Have you been diagnosed with atopic dermatitis (eczema)?
Is your eczema considered 'moderate' by a doctor?
Are you able to attend regular study appointments?
Are you willing to use a study cream daily?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would apply either the ruxolitinib cream or the 'dummy' cream to your skin. You wouldn't know which one you are using. You would have regular visits to the study clinic, where doctors and nurses would check your eczema, ask about your itching, and monitor your general health. This includes checking things like your blood and vital signs. They would also ask you to fill out questionnaires about how your eczema affects your daily life, your sleep, and your mood.

The study would involve several visits over a period of time, starting frequently in the beginning. The total length of your participation would be explained to you by the study team. You would be given instructions on how to use the cream and what to look out for. Your commitment would involve following these instructions and attending all your scheduled appointments.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as receiving a new treatment for your eczema that might improve your symptoms. You will also be closely monitored by medical professionals, which means any changes in your health will be noticed. However, there are also potential risks; for example, the cream might not work for you, or you might experience side effects. It’s important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

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

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Unverified
Spain
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Unverified
Italy
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Unverified
Poland
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Unverified
Netherlands
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Unverified
Germany
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Unverified
Hungary
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Unverified
Bulgaria
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Unverified
Belgium
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Unverified
France

Common questions

What is atopic dermatitis?

Atopic dermatitis is a common type of eczema that makes your skin dry, red, and very itchy.

What is 'ruxolitinib cream'?

It's a new cream being tested to see if it can help improve symptoms of moderate eczema.

What is a 'dummy' cream?

It's a cream that looks and feels like the medicine being tested, but it doesn't contain any active drug. It helps ensure fair test results.

Will I know if I'm getting the real cream or the dummy cream?

No, neither you nor your study doctor will know which cream you are receiving. This is called 'double-blind'.

What does a 'Phase 3b' study mean?

It means this is one of the later stages of testing a new medicine, focusing on confirming how well it works and its safety in a larger group of people.