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RecruitingOBSERVATIONAL

Real-world Effectiveness Study of Long-term Treatment With Dupilumab in Participants ≥6 Years With Atopic Dermatitis

This study is for people aged 6 and older in Germany who are taking Dupilumab for their eczema. It's an observational study, meaning researchers will simply watch and record how the treatment works in real-world settings, rather than giving out new medication. They want to understand how Dupilumab affects symptoms, quality of life, and how well eczema is controlled over two years. The study also looks at the patients' medical history, other health conditions, and any other treatments they are using. The main goal is to see how effective Dupilumab is long-term and to collect information on its safety in adults, teenagers, and children.

At a glance

Status
Recruiting
Sponsor
Sanofi
Enrolment target
900
Start
07 Mar 2023
Estimated completion
08 Mar 2028

What is this study about?

This study is designed to understand how a medication called Dupilumab works for people with eczema (atopic dermatitis) in their everyday lives. It's an "observational study," which means the researchers won't be asking anyone to change their usual treatment or try anything new. Instead, they will be looking at information from patients aged 6 and over who are already receiving Dupilumab as part of their routine care.

The main aim is to see how well Dupilumab helps control eczema symptoms, improves quality of life, and how safe it is over a longer period, specifically 24 months. Researchers will collect details about people's medical history, other conditions they might have (especially other allergic conditions like asthma or hay fever), and any other treatments they are using alongside Dupilumab. This helps build a picture of how the medication is used in real life, not just in a controlled trial setting.

By gathering this information, such as how often people take their medication, why they started or stopped it, and how effective it is over 6, 12, and 24 months, the study hopes to learn more about the long-term benefits and safety of Dupilumab for adults, teenagers, and children with eczema, especially those with other allergic conditions.

Key takeaways

  • This study looks at Dupilumab for eczema in people aged 6 and over.
  • It's an 'observational' study, meaning no new treatments are given.
  • Researchers will collect information at your regular doctor visits for up to two years.
  • The study aims to understand Dupilumab's long-term effects on symptoms and quality of life.
  • It also collects safety information in adults, teenagers, and children.

Who may be eligible?

To be considered for this study, you must be at least 6 years old. If you are an adult or teenager (aged 12 or older), you should have moderate to severe eczema and have recently started Dupilumab. If you are a child between 6 and 11 years old, you should have severe eczema and have recently started Dupilumab. You, or your parent/guardian if you are a child, must be able to understand and fill out some questionnaires related to the study. Finally, you or your parent/guardian will need to give written permission to take part.

There are a few reasons why someone might not be able to join. You cannot participate if your doctor believes Dupilumab is not suitable for you for any reason, or if you have already been taking Dupilumab for more than 7 days. Also, if you have other health problems that would make it difficult for you to complete the study questionnaires, or if your doctor thinks it would affect the results, you won't be able to take part. Lastly, if you are already involved in another similar study that your doctor thinks might affect the results of this one, you would not be eligible.

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.

  1. I am at least 6 years old.
  2. I have eczema (atopic dermatitis) and have recently started Dupilumab.
  3. If I am 12 or older, my eczema is moderate to severe. If I am 6-11, my eczema is severe.
  4. I/my guardian can understand and complete study questionnaires.
  5. My doctor has not said Dupilumab is unsuitable for me.
  6. I haven't been on Dupilumab for more than 7 days already.
Answer every question to see your result.

What does participation involve?

If you join this study, your involvement will last for up to two years, or until you stop taking Dupilumab, whichever comes first. This is an observational study, so you won't be given any new medication by the study itself; you will continue to receive Dupilumab as prescribed by your doctor as part of your usual care. You'll attend your regular doctor's appointments as you normally would for your eczema treatment. At these appointments, researchers will collect information about your eczema symptoms, how you're feeling, and your quality of life using questionnaires. The study simply records information during your routine visits, so no extra visits are needed beyond your standard care.

Potential risks and benefits

The main benefit of participating is that you help researchers learn more about Dupilumab and how it works for people with eczema in real-life situations. This information can help improve eczema care for others in the future. As this is an observational study, you will not be given new medication or procedures, so the direct physical risks are minimal. The main inconvenience might be the time taken to complete questionnaires during your regular doctor visits. You are free to withdraw from the study at any time without affecting your medical care.

Locations (55)

  • Investigational Site Number: 061
    Verified postcode
    Aachen, Germany· Recruiting
  • Investigational Site Number: 092
    Verified postcode
    Ahaus, Germany· Recruiting
  • Investigational Site Number: 066
    Verified postcode
    Andernach, Germany· Recruiting
  • Investigational Site Number: 002
    Verified postcode
    Berlin, Germany· Recruiting
  • Investigational Site Number: 003
    Verified postcode
    Berlin, Germany· Recruiting
  • Investigational Site Number: 176
    Verified postcode
    Berlin, Germany· Recruiting
  • Investigational Site Number: 077
    Verified postcode
    Berlin, Germany· Recruiting
  • Investigational Site Number: 004
    Verified postcode
    Berlin, Germany· Recruiting
  • Investigational Site Number: 174
    Verified postcode
    Berlin, Germany· Recruiting
  • Investigational Site Number: 073
    Verified postcode
    Berlin, Germany· Recruiting
  • Investigational Site Number: 059
    Verified postcode
    Braunschweig, Germany· Recruiting
  • Investigational Site Number: 057
    Verified postcode
    Buxtehude, Germany· Recruiting

Common questions

What is Dupilumab?

Dupilumab is a medication used to treat certain conditions, including eczema, by targeting specific parts of your immune system that cause inflammation.

Will I have to take any new medicines for this study?

No, this is an observational study. You will continue to take Dupilumab as prescribed by your own doctor as part of your normal care.

How long will I be in the study?

You will be part of the study for up to two years, or until you stop taking Dupilumab, whichever happens first.

Do I need extra doctor visits for this study?

No, all information for the study will be collected during your regular, planned doctor's appointments for your eczema treatment.

What kind of questions will I be asked?

You'll be asked about your eczema symptoms, how you're feeling, and how your eczema affects your everyday life through questionnaires.

How to find out more

Trial Transparency email recommended (Toll free for US & Canada)

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Real-world Effectiveness Study of Long-term Treatment With D…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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