Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

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 is a 'Phase 3' study, which means it's one of the final steps before a new medicine might become available. It's testing a drug called Upadacitinib for teenagers and adults who have moderate to severe atopic dermatitis (a type of eczema). Patients will receive either the active drug or a 'placebo' (a dummy pill with no medicine) without knowing which one they have. The main goal is to see how many people have their eczema significantly clear up and how many experience a big reduction in their itching after 16 weeks, compared to those taking the placebo. This helps doctors understand if Upadacitinib is safe and effective.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Abbvie Deutschland GmbH & Co. KG

Enrolment target

380

Start

07 Nov 2023

Moderate and Severe Atopic Dermatitis

What is this study about?

This study is looking into a new treatment called Upadacitinib for people aged 12 and over who have moderate to severe atopic dermatitis, which is a common and often challenging form of eczema. When you have atopic dermatitis, your skin can be very dry, itchy, and irritated, sometimes leading to red patches, swelling, and broken skin. Current treatments can help, but researchers are always looking for even better ways to manage the condition and improve quality of life. This particular study is designed to be very thorough, comparing the new medicine to a dummy pill to see if it really makes a difference.

To make sure the results are fair and accurate, this study is 'randomised' and 'double-blind'. Randomised means that participants are put into groups by chance – some will get Upadacitinib and others will get a 'placebo' (a pill that looks the same but contains no active medicine). Double-blind means neither you nor your study doctor will know whether you're taking the active medicine or the placebo. This helps prevent anyone's expectations from affecting the results. After a certain period, everyone involved will find out what treatment they received.

The main things the researchers want to find out are how well Upadacitinib helps clear up eczema and reduce itching over 16 weeks. They use special scales to measure these improvements. For example, they look for how many people have their skin almost or completely clear, and how many experience a big drop in how itchy they feel. They also check how quickly these improvements happen and how the treatment affects daily life. This information is crucial for understanding the potential benefits of Upadacitinib.

Key takeaways

Tests a new medicine, Upadacitinib, for moderate to severe eczema.
Open to teenagers (12+) and adults with atopic dermatitis.
Compares the new drug to a dummy pill (placebo) to see if it's effective.
Focuses on improving skin clear-up and reducing itching.
Participation involves regular clinic visits and health checks.
You won't know if you're getting the active drug or placebo.

Who may be eligible?

To be considered for this study, you need to be at least 12 years old. There's no upper age limit, so adults of any age are welcome to inquire. The study is open to both males and females.

Crucially, you must have been diagnosed with moderate to severe atopic dermatitis. This means your eczema is more than just mild and significantly affects your skin and daily life. The study doctors will have specific criteria to confirm your eczema severity.

There will also be other medical checks and criteria to ensure the study is safe for you and that the results can be properly measured. For example, they might look at your general health, other medical conditions you have, or medicines you are currently taking. It's important to discuss all your health information with the study team.

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 at least 12 years old?
Have you been diagnosed with moderate to severe atopic dermatitis (eczema)?
Are you able to attend regular clinic appointments and follow study instructions?
Are you currently in general good health apart from your eczema (as determined by a doctor)?
Are you willing to consider taking a new medicine or a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be regularly visiting the study clinic for assessments. These visits would include check-ups by the study doctor or nurse to monitor your eczema and overall health. You would also have your skin examined and scored using special tools to track changes in your eczema's severity, redness, and affected area. You'd also be asked to rate your itching levels and how your eczema impacts your daily life by filling out questionnaires.

During the study, you would be taking either the study medicine, Upadacitinib, or a placebo (a dummy pill), usually once a day, for a specific period. You wouldn't know which one you are taking. There would be regular blood tests and other medical tests to check how you are responding to the treatment and to monitor for any side effects. After the main treatment period, there would likely be follow-up visits to see how you are doing off the study medicine or if you continue on the open-label part of the study. The total duration of your involvement, including all visits and follow-ups, would be explained to you in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment that isn't yet widely available, and close medical monitoring. However, there are also potential risks, including side effects from the study medication or from the procedures (like blood tests). The treatment might not help your condition, or it could even make it worse. You would receive a detailed document explaining all known and potential risks before you decide to join. Remember, participation is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

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

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Unverified
Netherlands
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Unverified
Denmark
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Unverified
Hungary
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Unverified
Ireland
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Unverified
Portugal
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Unverified
Italy
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Unverified
Belgium
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Unverified
France
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Unverified
Spain
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Unverified
Czechia
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Unverified
Croatia
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Unverified
Germany

Common questions

What is atopic dermatitis?

Atopic dermatitis is a common type of eczema that causes dry, itchy, and inflamed skin. It often starts in childhood and can come and go, with periods of clearer skin and flare-ups.

What does 'Phase 3' mean for a study?

Phase 3 is typically one of the final stages of testing a new medicine. It involves a larger number of patients and aims to confirm the drug's effectiveness, monitor side effects, and compare it to existing treatments or a placebo.

What is a 'placebo'?

A placebo is a 'dummy' pill or treatment that looks exactly like the real medicine but contains no active ingredients. It's used in studies to see if the new medicine works better than no treatment at all.

Will I know if I'm getting the real medicine or the placebo?

No, in this study, neither you nor your study doctor will know whether you are receiving the real medicine (Upadacitinib) or the placebo. This is called 'double-blind' and helps ensure the study results are unbiased.

Can I leave the study if I change my mind?

Yes, absolutely. You are free to withdraw from the study at any time, for any reason, without having to explain why. Your decision will not affect your future medical care.