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Active not recruitingOBSERVATIONAL

Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis (AD)

This study is observing people in the UK who are taking Dupixent for their eczema (atopic dermatitis) in a real-world setting. Researchers want to learn more about who takes Dupixent, their medical history, and how severe their eczema is. They also want to understand how Dupixent is actually used, including typical doses, how long people stay on it, and why they might stop or switch. The study will look at how well Dupixent works in the long term, any other health conditions people have, and how Dupixent affects these. Safety information will also be collected. The aim is to get a clearer picture of Dupixent's effectiveness and safety outside of strict clinical trial conditions.

At a glance

Status
Active not recruiting
Sponsor
Sanofi
Enrolment target
955
Start
11 Jun 2019
Estimated completion
31 Mar 2027

What is this study about?

This study is all about understanding how a medicine called Dupixent, used for a type of eczema called atopic dermatitis, works for people in their daily lives. Instead of a highly controlled experiment, researchers are simply observing patients who are already taking Dupixent as part of their regular treatment. They want to learn more about the kinds of people who use Dupixent – their age, background, and how severe their eczema is before they start the medication.

Researchers are also keen to see how Dupixent is actually used in the real world. This includes things like the typical doses people take, how long they use it, and if they stop or switch to another treatment – and why. They'll also be looking at how well Dupixent helps people manage their eczema over a long period, which is really important for understanding its true benefits. They'll also check if Dupixent helps with other related conditions, like asthma or hay fever, that often occur alongside eczema.

Finally, a major part of the study is to collect information about any side effects people experience while taking Dupixent. This helps doctors and patients understand the safety of the medication even better. By gathering all this information over five years, the study aims to give a clearer, more complete picture of how Dupixent works for people with eczema in their everyday lives, beyond what we learn from initial trials.

Key takeaways

  • Researchers are observing how Dupixent works for people with eczema in their daily lives.
  • The study aims to understand who takes Dupixent, how it's used, and how well it works long-term.
  • It will also collect safety information and track other related health conditions.
  • Participation involves providing information over five years, but doesn't change your medical care or provide free medication.
  • You must be 12 or older and starting or recently started Dupixent for eczema to be considered.
  • You can leave the study at any time without affecting your medical treatment.

Who may be eligible?

You might be able to take part in this study if you are 12 years old or older and are either about to start Dupixent for your eczema, or have recently started it (within the last 6 months).

If you're between 12 and 18, Dupixent must be approved for use in your age group in the UK for you to join. You'll also need to be able to understand and fill out some questionnaires and give your consent (or have your parent/guardian give it for you if you're under 18).

However, you won't be able to join if you have any health conditions that would make Dupixent unsuitable for you, if you have a very short expected lifespan, struggle with substance abuse, have severe memory problems, or other serious health issues that would make it hard to attend appointments. Also, if you're currently in another clinical trial that changes your medical care, or if you've recently used Dupixent in the last 6 months, you won't 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. Are you 12 years old or older?
  2. Are you starting or have you recently started (within the last 6 months) Dupixent for your eczema?
  3. Are you able to understand and complete questionnaires?
  4. Do you have any conditions that your doctor thinks might make it difficult for you to take part in a 5-year study?
  5. Are you currently taking part in another clinical trial that affects your medical care?
  6. Have you used Dupixent in the last 6 months (if you haven't just started it)?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be followed by the research team for five years. This involves regularly providing information about your health, your eczema, and how Dupixent is working for you. You'll likely complete questionnaires that ask about your symptoms, how your eczema affects your daily life, and any other health conditions you have. Since this is an observational study, you will continue to receive Dupixent as prescribed by your own doctor, and the study won't change your medical care. The goal is to simply observe your experiences. There are no special medications provided by the study, only data collection about your standard treatment. You will have regular assessments, similar to what your doctor might already do, to track your eczema and overall health during this five-year period.

Potential risks and benefits

Taking part in this study may help us understand Dupixent better, potentially benefiting others with eczema in the future. You will continue to receive your usual medical care, so there are no direct medical risks from participating in the study itself, beyond those associated with Dupixent treatment already prescribed by your doctor. The main 'risk' is the time commitment required to complete questionnaires and attend assessments. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (114)

  • Investigational Site Number : 0320013
    Verified postcode
    Pilar, Argentina
  • Investigational Site Number : 0320012
    Verified postcode
    Rosario, Argentina
  • Investigational Site Number : 0320011
    City only
    Ciudad Autonoma Bs As, Argentina
  • Investigational Site Number : 0360002
    Verified postcode
    Kogarah, Australia
  • Investigational Site Number : 0360005
    Verified postcode
    Kogarah, Australia
  • Investigational Site Number : 0360003
    Verified postcode
    Woolloongabba, Australia
  • Investigational Site Number : 0360004
    Verified postcode
    Bedford Park, Australia
  • Investigational Site Number : 0360001
    Verified postcode
    Carlton, Australia
  • Investigational Site Number : 0400005
    Verified postcode
    Graz, Austria
  • Investigational Site Number : 0400004
    Verified postcode
    Linz, Austria
  • Investigational Site Number : 0400002
    Verified postcode
    Maria Enzersdorf, Austria
  • Investigational Site Number : 0400001
    Verified postcode
    Vienna, Austria

Common questions

What is Dupixent?

Dupixent is a medicine used to treat moderate to severe eczema (atopic dermatitis) in adults and children.

Will I get free medicine if I join the study?

No, this study observes how Dupixent is used in real life. You will receive your medication as prescribed by your own doctor, not through the study.

How long will I be in the study?

If you join, you will be followed for five years to see how Dupixent affects your eczema over time.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without having to give a reason, and it won't affect your medical care.

What does 'real-world setting' mean?

It means the study looks at how Dupixent works for people in their everyday lives, not in strict, controlled trial conditions.

How to find out more

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

Discussion

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