A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis
This research study is looking into a new medicine called upadacitinib for adults aged 18 and older who have moderate to severe eczema (atopic dermatitis). The aim is to see if this medicine can effectively clear up their skin, reduce the troublesome itching, and generally improve their quality of life. Participants will be given either the new medicine or a dummy pill (placebo) without knowing which one they have received. Researchers will check their progress over 16 weeks by looking at how much their skin has improved and how much their itching has lessened. This is a 'Phase 3' study, meaning it's a large trial to confirm if the medicine works and is safe before it might become widely available.
At a glance
What is this study about?
This study is investigating a potential new treatment called upadacitinib for people suffering from moderate to severe atopic dermatitis, which is a common form of eczema. Eczema can be very uncomfortable, causing red, itchy, and inflamed skin, which can significantly impact daily life. Researchers want to find out if upadacitinib can help to improve these symptoms significantly.
To do this, the study will compare upadacitinib with a 'placebo', which is a dummy pill that looks just like the real medicine but contains no active ingredients. This comparison helps researchers understand if any improvements are truly due to the new medicine or if they might happen naturally or due to a belief in treatment. Participants won't know if they're receiving the actual medicine or the placebo, and neither will their study doctors, ensuring fair results. The main aim is to see how many people see a clear improvement in their eczema and itching after 16 weeks of treatment.
The study also looks at several other important factors, such as how quickly itching improves, whether the skin clears up even more dramatically, and how the quality of life for participants changes. By gathering all this information, the researchers hope to understand the full benefits and any potential drawbacks of upadacitinib, aiming to provide more effective treatment options for people with eczema in the future.
Key takeaways
- This study is for adults (18+) with moderate to severe eczema (atopic dermatitis).
- It's testing a new medicine called upadacitinib against a dummy pill (placebo).
- The goal is to see if it improves eczema symptoms like skin clarity and itching.
- Participants will take daily medicine for 16 weeks with regular check-ups.
- It's a 'double-blind' study, meaning you won't know if you're on the real drug or placebo.
Who may be eligible?
This study is looking for adult volunteers, aged 18 years and older, who have been diagnosed with moderate to severe atopic dermatitis, also known as eczema. Both men and women are welcome to take part.
To be considered, your eczema needs to be affecting you significantly, meaning it's not just a mild case. Your doctors will use specific ways to measure how severe your eczema is to make sure you meet the study requirements.
There will also be other criteria, like your general health and any other medications you might be taking, that will be checked to ensure it's safe for you to participate and that the study results will be clear. You'll discuss all these details with the study team to confirm if 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 moderate to severe eczema (atopic dermatitis)?
- Are you able to commit to 16 weeks of treatment and clinic visits?
- Are you generally in good health, apart from your eczema?
What does participation involve?
If you decide to join this study, you'll be randomly assigned to receive either the new medicine (upadacitinib) or a dummy pill (placebo) – you won't know which one you're taking, and neither will your study doctor. You'll take this medicine every day for 16 weeks. Throughout this time, you'll have regular visits to the clinic.
During these visits, the study team will carefully check your skin, pay attention to how much your eczema and itching have improved, and ask you questions about how you're feeling and how your eczema is affecting your daily life. They'll also monitor your general health with tests like blood samples. The total duration of active treatment and close monitoring for the main part of the study is 16 weeks.
Potential risks and benefits
Locations (9)
- —UnverifiedFrance
- —UnverifiedEstonia
- —UnverifiedCroatia
- —UnverifiedFinland
- —UnverifiedDenmark
- —UnverifiedBulgaria
- —UnverifiedRomania
- —UnverifiedGermany
- —UnverifiedItaly
Common questions
What is atopic dermatitis?
Atopic dermatitis is a common type of eczema that causes dry, red, itchy skin. It often starts in childhood but can affect adults too.
What is a 'Phase 3' study?
Phase 3 means this is a large study to confirm if a new medicine is safe and effective enough to be approved for wider use.
What is a placebo?
A placebo is a dummy pill with no active ingredients. It looks just like the real medicine but helps researchers compare its actual effects.
Will I know if I'm getting the real medicine?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know if you're taking the active medicine or the placebo.
How long will I be in the study?
The main part of the study involves 16 weeks of taking the study medicine and having regular check-ups.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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