A Phase 3b/4 Randomized, Blinded, Treat-to-Target and Dose-Flexibility Study of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis (Flex-Up)
This research study is investigating an existing medicine called Upadacitinib for adults who have eczema that ranges from moderate to severe. It's designed to understand how effective this treatment is at improving skin symptoms and how it affects a person's everyday life. Researchers are especially interested in seeing how many people achieve a near-complete clearing of their eczema symptoms after 24 weeks. The study will also look at how quickly symptoms like itching improve and how different ways of adjusting the medicine's dose might work. This is an advanced-stage study, meaning the medicine has already been well-studied, and now researchers are fine-tuning how best to use it.
At a glance
What is this study about?
This study is about a medicine called Upadacitinib, which is used to treat moderate to severe atopic dermatitis, more commonly known as eczema. Eczema is a long-lasting condition that makes your skin red, itchy, and dry. For some people, it can be very uncomfortable and affect their daily lives.
The main goal of this study is to see how well Upadacitinib works in clearing up eczema symptoms. Specifically, researchers want to find out how many people can achieve a significant improvement in their skin, aiming for almost clear skin (around 90% better) after about six months (24 weeks) of treatment. They will also look at other important things, like how much less itchy people feel, how the medicine affects their quality of life, and how quickly these improvements happen.
This is a 'Phase 3b/4' study, which means the medicine has already been shown to be safe and effective in earlier studies. Now, the researchers are looking more closely at the best ways to use the medicine in real-world situations, including how to adjust the dose to get the best results for each person. This kind of research helps doctors understand how to use treatments like Upadacitinib most effectively for their patients.
Key takeaways
- This study is for adults with moderate to severe eczema.
- It tests an existing medicine called Upadacitinib.
- The main goal is to see how much the medicine improves skin and itching.
- It also looks at how different doses work best.
- Participation involves regular clinic visits and close monitoring.
- You can stop participating at any time.
Who may be eligible?
To be part of this study, you need to be an adult, aged 18 or older. Both men and women can take part.
Because this study is looking at a treatment for eczema, you would need to have been diagnosed with moderate to severe atopic dermatitis (eczema). The study team will check your medical history and current health carefully to make sure the study is a good fit for you.
There might be other specific health conditions or medications that would mean you couldn't join, but the doctors running the study will discuss all of these details with you.
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 moderate to severe eczema (atopic dermatitis)?
- Are you able to attend regular appointments at a clinic?
- Are you willing to take a study medicine and not know which dose you are on?
What does participation involve?
If you decide to take part in this study, you would be assigned to one of several treatment groups, where you would receive either the study medicine, Upadacitinib, or another active dose. This is a "blinded" study, meaning neither you nor your study doctor will know which treatment group you are in to ensure fair results. You would take the medicine as directed by the study team.
Throughout the study, you would attend regular visits at the clinic. During these visits, the study team would check your health, assess your eczema symptoms, and ask about any side effects or changes you experience. They would use special scales and questionnaires to measure how your skin is improving, how much itching you have, and how your daily life is affected. The study involves long-term follow-up to monitor your progress and safety.
Potential risks and benefits
Locations (10)
- —UnverifiedNetherlands
- —UnverifiedSpain
- —UnverifiedPortugal
- —UnverifiedGermany
- —UnverifiedHungary
- —UnverifiedBelgium
- —UnverifiedSlovakia
- —UnverifiedItaly
- —UnverifiedBulgaria
- —UnverifiedPoland
Common questions
What is eczema?
Eczema, or atopic dermatitis, is a common skin condition that makes your skin red, itchy, and dry. It can range from mild to severe.
What is Upadacitinib?
Upadacitinib is a medicine already used to treat certain inflammatory conditions, including eczema, in some people.
What does 'blinded' mean in a study?
It means neither you nor your study doctor will know which specific treatment dose you are receiving. This helps make the study results fair and unbiased.
What is meant by 'moderate to severe' eczema?
This refers to eczema that significantly affects a person's life, with widespread or intense symptoms, and often hasn't responded well to standard treatments.
How long will the study last?
The study involves regular assessments over at least 24 weeks, but the overall duration and follow-up will be explained by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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