J2T-MC-KGBI/DRM06-AD13: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age with Moderate-to-Severe Atopic Dermatitis
This research study is looking at a new medicine, lebrikizumab, for children and teenagers from 6 months old up to 18 years, who have moderate to severe eczema (also known as atopic dermatitis). The main goal is to find out if this new medicine is effective at making eczema better and if it's safe to use. Some participants will receive the active medicine, while others will get a 'dummy' medicine (placebo), without knowing which one they have. This helps us fairly compare the new medicine's effects. We'll be checking how much the eczema improves and if there are any side effects. This is a vital step in developing new treatments for eczema.
At a glance
What is this study about?
This study is called a 'Phase 3' trial. This means it's one of the final steps in testing a new medicine before it can be considered for wider use. We're investigating a medicine called lebrikizumab for children and teenagers with moderate to severe eczema. Eczema can be very uncomfortable, causing itchy, red, and dry skin, and can really affect daily life for young people and their families. This study aims to find a new way to help manage these symptoms.
We are comparing lebrikizumab against a 'placebo', which is a dummy treatment that looks just like the real medicine but contains no active ingredients. This is a common and important way to test new medicines. Neither the participants nor their doctors will know who is receiving the actual medicine and who is getting the placebo. This helps ensure that the results are as fair and unbiased as possible, allowing us to accurately see if lebrikizumab genuinely makes a difference.
The main things we want to find out are how well lebrikizumab clears up the eczema and whether it causes any side effects. We'll be looking at how many participants see their eczema clear completely or almost completely, and how many experience a significant reduction in the severity and area of their eczema. The results of this study will help us understand if lebrikizumab could be a valuable new treatment option for young people living with moderate to severe eczema.
Key takeaways
- It's a study for children and teens (6 months to under 18) with moderate to severe eczema.
- It's testing a new medicine called lebrikizumab against a dummy medicine (placebo).
- The aim is to see if lebrikizumab is safe and helps improve eczema symptoms.
- Participation involves regular clinic visits for checks and medicine administration.
- You will not know if your child is getting the active medicine or the placebo.
Who may be eligible?
This study is designed for children and teenagers who have eczema, specifically from 6 months old up to just under 18 years of age. Both boys and girls can take part.
To be considered for the study, your child's eczema needs to be classed as 'moderate to severe'. This means it's not just a mild rash, but something that regularly bothers them and might be difficult to control with standard treatments. The study team will check your child's medical history and current eczema to make sure they meet all the specific requirements.
There might be other health conditions or medicines that would mean a child couldn't join the study, to ensure their safety. The study doctors will carefully review all these details with you during the screening process.
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.
- Is your child between 6 months and just under 18 years old?
- Does your child have eczema (atopic dermatitis)?
- Is your child's eczema considered moderate to severe by a doctor?
- Is your family able to attend regular clinic appointments?
What does participation involve?
If your child takes part, it will involve regular visits to a clinic over a period of time. These visits will include checks of their skin, discussions about how they're feeling, and possibly blood tests or other assessments to see how the medicine is working and to monitor their health. Your child will receive either the study medicine (lebrikizumab) or a placebo (dummy medicine), which will be given in a specific way as instructed by the study team.
During the study, you'll need to keep a record of your child's symptoms and any changes you notice. The study team will provide all the necessary information and support. After the main treatment period, there will be follow-up visits to ensure your child's well-being and to collect final information about the medicine's effects. The total duration of participation will depend on the specific schedule of the study, which the research team will explain in detail.
Potential risks and benefits
Locations (5)
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedCzechia
- —UnverifiedGermany
- —UnverifiedFrance
Common questions
What is eczema?
Eczema, also called atopic dermatitis, is a common skin condition that makes your skin red, itchy, and dry. It's not infectious.
What is 'moderate to severe' eczema?
This means your child's eczema is quite bothersome, covers a noticeable area of their body, and might not be well controlled with usual treatments.
What is a 'placebo'?
A placebo is a 'dummy' medicine that looks like the real treatment but contains no active ingredients. It helps us fairly compare the new medicine's effects.
Will my child definitely get the new medicine?
No, this is a 'randomised' study, meaning your child will be randomly assigned to either receive the new medicine or the placebo. Neither you nor the doctors will know which one.
How long will the study last?
The study team will explain the exact duration of treatment and follow-up during your initial discussions.
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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