I4V-MC-JAIP: A Phase 3, Multicenter, Randomized, Double blind, Placebo controlled, Parallel group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients with Moderate-to-Severe Atopic Dermatitis
This important study is testing a new drug called Baricitinib for children and teenagers who have eczema that's moderate to severe. Eczema can be very itchy and uncomfortable, so finding new ways to help is crucial. The study is comparing Baricitinib to a placebo (a dummy pill with no medicine) to see how well it works and if it's safe. Participants will be taking either Baricitinib or the placebo, alongside some common eczema creams. The researchers will be carefully checking how well the skin improves and how the body handles the new medicine. This is a "Phase 3" study, which means it's one of the final steps to see if the medicine can become widely available.
At a glance
What is this study about?
This study is all about helping children and teenagers who suffer from eczema. Eczema, also known as atopic dermatitis, can make skin very dry, red, and itchy, causing a lot of discomfort. Doctors and scientists are always looking for better ways to treat it, and this study focuses on a new medicine called Baricitinib.
The main goal is to find out if Baricitinib can significantly improve eczema symptoms in young people. Participants will be split into different groups. Some will receive Baricitinib, while others will get a 'placebo' – this looks exactly like the medicine but contains no active drug. This comparison helps researchers truly understand if the improvements seen are due to the medicine itself. Everyone in the study will also use some standard eczema creams, like triamcinolone acetonide or hydrocortisone, as directed by the study doctors.
Throughout the study, doctors will regularly assess how much the skin has improved. They'll also take samples, like blood tests, to see how the body absorbs and uses the medicine. This helps them understand the right dose and how safe the medicine is for young people. Because this is a "Phase 3" study, it means the medicine has already shown some promise in earlier tests, and now they need to confirm its benefits and safety on a larger group.
Key takeaways
- The study is for children and teenagers with moderate to severe eczema.
- It's testing a new medicine called Baricitinib against a dummy pill (placebo).
- Its main goal is to see if Baricitinib is safe and helps eczema improve.
- Participants will also use standard eczema creams.
- Regular clinic visits and blood tests will be part of taking part.
- You can stop participating at any time.
Who may be eligible?
This study is open to children and teenagers who have been diagnosed with moderate to severe eczema. Both boys and girls can take part, regardless of their age.
The doctors running the study will check specific details of your eczema, such as how severe it is and if you've tried other treatments. They will also look at your general health to make sure joining the study is safe for you.
It's important to remember that even if you meet the general age range and have eczema, there might be other medical reasons or conditions that mean you can't join the study. The study team will discuss all the specific requirements with you.
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.
- Do you have moderate to severe eczema?
- Are you a child or teenager?
- Are you generally healthy, apart from your eczema?
- Are you able to attend regular clinic appointments?
- Are you comfortable with taking study medication and having blood tests?
What does participation involve?
If you decide to join this study, you would first have a full check-up to make sure it's right for you. If you qualify, you'll be given either the study medicine (Baricitinib) or a placebo (a dummy pill) and specific eczema creams to use. You won't know which one you're receiving.
You'll need to attend regular visits to the study clinic for examinations by the doctors. During these visits, they will check your skin, ask about your symptoms, and take blood samples to see how the medicine is working and to ensure your safety. There will also be follow-up calls or visits after your main treatment period. The total time you'd be involved in the study would depend on the specific treatment plan, but it will be clearly explained before you agree to take part.
Potential risks and benefits
Locations (7)
- —UnverifiedHungary
- —UnverifiedCzechia
- —UnverifiedPoland
- —UnverifiedFrance
- —UnverifiedAustria
- —UnverifiedSpain
- —UnverifiedGermany
Common questions
What is eczema?
Eczema, or atopic dermatitis, is a common condition that makes your skin red, dry, and very itchy.
What is Baricitinib?
Baricitinib is a new medicine being tested to see if it can help improve eczema symptoms in young people.
What is a 'placebo'?
A placebo is a dummy pill or treatment that looks like the real medicine but contains no active drug. It helps compare the new medicine's effects.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'blinded' study, so neither you nor the doctors will know if you're taking Baricitinib or the placebo until the study is over.
What happens after the study ends?
After the study, the doctors will have learned a lot, which could help this medicine become available to more people if it's proven safe and effective.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.