Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)
This research study is designed to understand the long-term safety of a medicine called dupilumab for children and teenagers aged 6 months to under 18 years who have a type of eczema known as atopic dermatitis. It also aims to see how effective the medicine is over a longer period. Scientists will look at how much of the medicine stays in the body and if the body creates a reaction to it. There's also an optional part of the study for children aged 2 to under 12 years, focusing on a new type of injection pen. This part will check how the body absorbs the medicine from the pen and if it's safe to use. If your child has previously been in a dupilumab study for eczema, they might be able to join this one.
At a glance
What is this study about?
This study is all about understanding a medicine called dupilumab when used long-term for children and teenagers with eczema, also known as atopic dermatitis. Eczema can be very itchy and uncomfortable, so finding safe and effective treatments is important. The main goal of this study is to carefully watch for any side effects and understand the medicine's safety over time when given to young people from 6 months up to 18 years old. This is crucial because children and teenagers react to medicines differently than adults, and long-term data helps doctors make the best decisions.
Beyond safety, the study also wants to see how well dupilumab continues to help with eczema symptoms over a longer period. This means researchers will be looking at things like how much the itching is reduced, how the skin looks, and generally how much better participants feel. They will also be checking the levels of the medicine in the blood and if the body's immune system develops a response to it. This helps them understand how the medication works and if it keeps working effectively.
There's an optional extra part of the study for younger children (aged 2 to under 12) who have eczema. This part is specifically looking at a new, easier-to-use injection device, often called a 'pre-filled pen'. The aim here is to make sure the medicine is absorbed correctly from this new device and that it's safe to use. If your child meets the criteria and you're interested, you might be able to take part in this optional sub-study.
Key takeaways
- Checks long-term safety of dupilumab for children and teens with eczema.
- Also assesses how well dupilumab continues to work over time.
- Only for children who have previously used dupilumab in a study.
- Optional extra part investigates a new injection pen for younger children.
- Contribution helps future understandings of eczema treatment in young people.
Who may be eligible?
To be able to join this study, your child must have already taken part in a previous dupilumab study for eczema in children and completed all the necessary appointments and checks in that earlier study.
For the optional part of the study involving the new injection pen, your child must be between 2 and under 12 years old and weigh between 5 and 60 kilograms (about 11 to 132 pounds). They also need to have been using the same dose of dupilumab with the regular pre-filled syringe in the main part of the ongoing study for at least the last 12 weeks.
There are some reasons why your child might not be able to join. For example, if they had a serious side effect in a previous dupilumab study that the doctors believe makes it too risky for them to continue. Also, if they've recently taken certain other study medicines, immunosuppressant drugs, or received a live vaccine within a specific timeframe. Finally, if they have certain serious health conditions or active parasitic infections, they wouldn't be able to participate. For the pen study, poor medicine-taking habits (missing injections) in the past 12 weeks would also exclude them.
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.
- Has your child participated in a previous dupilumab study for eczema?
- Did your child complete all visits in that previous study?
- Is your child currently between 6 months and under 18 years old?
- For the optional pen study: Is your child 2 to under 12 years old and weighing between 5 kg and 60 kg?
- For the optional pen study: Has your child been consistently taking dupilumab by syringe at the same dose for the last 12 weeks?
What does participation involve?
If you decide to take part in this study, your child will continue to receive dupilumab, the same medicine they received in the previous study. The study team will regularly check your child's health, their eczema symptoms, and how their body is reacting to the medicine. This will involve appointments, possibly blood tests, and skin checks. These visits will be needed for as long as your child is in the study to monitor their safety and how well the treatment is working long-term. The total duration of participation will be discussed by the study team, but it's designed to assess long-term effects.
Potential risks and benefits
Locations (84)
- Regeneron Investigational SiteVerified postcodeBirmingham, United States
- Regeneron Investigational SiteVerified postcodeGilbert, United States
- Regeneron Investigational SiteVerified postcodeBakersfield, United States
- Regeneron Investigational SiteVerified postcodeLong Beach, United States
- Regeneron Investigational SiteVerified postcodeLos Angeles, United States
- Regeneron Investigational siteVerified postcodeMission Viejo, United States
- Regeneron Investigational SiteVerified postcodeOrange, United States
- Regeneron Investigational SiteVerified postcodePalo Alto, United States
- Regeneron Investigational SiteVerified postcodeRolling Hills Estates, United States
- Regeneron Investigational SiteVerified postcodeSan Diego, United States
- Regeneron Investigational SiteVerified postcodeCentennial, United States
- Regeneron Investigational SiteVerified postcodeWashington D.C., United States
Common questions
What is dupilumab?
It's a medicine used to treat moderate to severe eczema (atopic dermatitis) in children and adults, helping to calm the immune system that causes the skin problems.
Why is this study only for children who have already used dupilumab?
This study is looking at the *long-term* safety and effectiveness, so it needs children who have already started the treatment in a previous study.
What is the pre-filled pen (PFP) sub-study?
It's an optional extra part of the study looking at a new, perhaps easier, injection device for giving dupilumab to younger children, checking how well it works and if it's safe.
Will my child get a placebo (dummy medicine) in this study?
No, if your child is eligible for this study, they will continue to receive dupilumab, as they have in a previous study.
What if my child experiences a side effect during the study?
The study team will closely monitor your child for any side effects, and they are there to provide care and support if any issues arise. You should always report any concerns immediately.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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