LP0162-1335: A single (assessor) blinded, randomized, parallel-group, monotherapy trial to evaluate the pharmacokinetics and safety of tralokinumab in children (age 6 to <12 years) with moderate to-severe atopic dermatitis. - TRAPEDS 1 (TRAlokinumab PEDiatric trial no. 1).
This study, named TRAPEDS 1, is designed for children aged 6 to under 12 who are living with moderate to severe eczema. We are exploring a medicine called Adtralza, given as an injection. The main goals are to understand how the medicine travels through the body of a child (like how much medicine is in the blood at different times) and to check for any side effects or safety concerns. This will help us learn more about using Adtralza for children with eczema. We will also be looking at how the eczema changes over time using special scoring systems. The study aims to gather important information to potentially help children in the future.
At a glance
What is this study about?
If you're a parent of a child with moderate to severe eczema, you know how challenging it can be. This study, called TRAPEDS 1, is looking at a new medicine called Adtralza for children between 6 and 12 years old who have this condition. Eczema (also known as atopic dermatitis) can make skin very itchy, dry, and inflamed, affecting a child's daily life.
The main purpose of this study is to understand how Adtralza works inside a child's body. We'll be checking things like how much of the medicine is in their blood at different times after they receive an injection. This helps us work out the best amount of medicine to give and how often. We'll also be carefully looking for any side effects to make sure the medicine is safe for children.
The study also aims to see if Adtralza helps improve the symptoms of eczema. We'll be using special tools and questionnaires to measure changes in itch, redness, and overall skin condition over time. The information gathered from this study is really important for developing new and potentially better treatments for children with eczema in the future.
Key takeaways
- Study for children 6-12 years old with moderate to severe eczema.
- Investigating a new medicine called Adtralza (an injection).
- Focus is on how the medicine works in the body and its safety.
- Will also monitor changes in eczema symptoms over time.
- Participation involves regular clinic visits for blood tests and health checks.
- You can withdraw your child from the study at any time.
Who may be eligible?
This study is specifically designed for children who are between 6 and 12 years old. They need to have moderate to severe eczema, which means their skin condition is causing significant problems.
Both boys and girls are welcome to take part in this study. There might be some other specific health requirements or conditions that would mean a child isn't right for this particular study, but those details would be discussed with you by 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.
- Is my child between 6 and 12 years old?
- Does my child have eczema that's considered moderate to severe?
- Is my child suitable for taking part in a clinical study?
- Are we able to attend regular clinic appointments?
What does participation involve?
If your child takes part, they would receive the study medicine, Adtralza, as an injection. The study involves a series of visits to the clinic over a number of weeks. During these visits, the study team would take blood samples to measure how the medicine is working in your child's body. They would also do checks to see how your child's eczema is changing and if they are experiencing any side effects.
The study has different parts. The initial treatment period lasts for 16 weeks, where the medicine and checks are closely monitored. After that, there's an open-label period up to 68 weeks, and then potentially a longer follow-up period. The total time a child could be involved in the study could be quite long, but you would have regular appointments for check-ups and to receive the study medicine. Throughout the study, various scales will be used to monitor how your child's eczema is progressing.
Potential risks and benefits
Locations (4)
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedNetherlands
- —UnverifiedCzechia
Common questions
What is eczema?
Eczema, or atopic dermatitis, is a common skin condition that makes skin very dry, red, itchy, and sometimes cracked. It can be uncomfortable and affect daily life.
What is Adtralza?
Adtralza is a medicine that is being studied for treating eczema. It's given as an injection and aims to reduce the inflammation and symptoms of eczema.
What does 'single-blinded' mean?
It means that the person who is checking how your child's eczema is doing won't know if your child is getting the actual medicine or a dummy treatment (if there was one). This helps make the results fair.
Will my child get the actual medicine?
Yes, in this study, all children will receive the study medicine, Adtralza. There isn't a placebo (dummy treatment) group in the main part of this study.
How long will the study last for my child?
Your child could be in the study for a long time, potentially over a year, with regular check-ups. The initial part is 16 weeks, followed by longer periods.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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