Active not recruitingPHASE3INTERVENTIONAL

A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis

This research study is looking into a new medicine called baricitinib for children and teenagers between 2 and 17 years old who have moderate to severe atopic dermatitis, also known as eczema. Many children with eczema find their current treatments don't work well enough. This study aims to find out if baricitinib is both safe and effective in improving eczema symptoms. Some participants will receive the study medicine, others a dummy pill (placebo), and some will continue with their usual skin creams. The goal is to see if this new approach could offer a better way to manage eczema for young people, helping them feel more comfortable and improve their quality of life.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

516

Start

24 May 2019

Estimated completion

01 May 2026

Atopic Dermatitis

What is this study about?

This study is investigating a medicine called baricitinib for children and teenagers troubled by moderate to severe eczema, also known as atopic dermatitis. Eczema is a long-term condition that makes skin dry, itchy, red, and sometimes cracked. When eczema is moderate to severe, it can really impact a child's daily life, making it hard to sleep, concentrate, and feel comfortable.

The main goal of this study is to find out if baricitinib is safe to use in this age group and if it helps to improve their eczema more than a dummy pill (placebo) or steroid creams applied to the skin. The study will carefully monitor participants to see how their skin conditions change and if there are any side effects from the medication.

Developing new and effective treatments for children with eczema is really important. Current treatments don't work for everyone, and some children need more options to help manage their symptoms. This study could help doctors understand if baricitinib can offer a new and better way to control eczema, leading to improved skin health and quality of life for young people.

Key takeaways

This study is testing a new medicine for children and teenagers (2-17 years) with moderate to severe eczema.
It aims to see if the medicine, baricitinib, is safe and effective compared to a dummy pill or steroid creams.
Participants will have their health and eczema carefully monitored throughout the study.
Some existing eczema treatments may need to be stopped or adjusted.
Joining the study is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, children and teenagers generally need to be between 2 and 17 years old and have moderate to severe eczema that has been diagnosed for a certain length of time (at least 6 or 12 months, depending on their age). Their eczema should not have responded well to creams applied to the skin in the past six months.

There are also some reasons why someone might not be able to join. For example, if they have other serious skin conditions like psoriasis or lupus, or if their eczema is very severe and often requires hospital stays. Children who have had a type of eczema infection called eczema herpeticum recently, or have had it multiple times, would not be suitable.

Also, if a child needs treatment for other serious illnesses, has certain infections, or has previously taken a similar type of oral eczema medicine, they might not be able to participate. It's important to discuss your child's full medical history with the study team to see if they meet all the requirements.

Quick self-check

Is your child aged between 2 and 17 years?
Does your child have moderate to severe eczema?
Has their eczema been diagnosed for at least 6-12 months?
Have their skin creams not worked well enough in the past 6 months?
Does your child currently have a serious skin infection or have had specific eczema infections recently?
Does your child have any other serious health conditions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your child takes part, they will receive either the study medicine (baricitinib), a dummy pill (placebo), or their usual steroid creams. The study team will regularly check your child's skin and overall health through appointments and assessments. This will involve physical examinations, questionnaires, and possibly blood tests.

You will need to make sure your child uses moisturising creams (emollients) daily throughout the study. Certain other eczema treatments might need to be stopped before and during the study. The total duration of participation isn't specified but typically involves regular visits over several months.

Potential risks and benefits

Participating in this study might offer your child the potential benefit of trying a new medicine that could improve their eczema symptoms if current treatments haven't worked well. However, there's also a chance they might receive a dummy pill, meaning their eczema might not improve, or they might experience side effects from the study medicine. All medicines carry potential risks, and these will be fully explained to you. You are free to withdraw your child from the study at any time, for any reason, without it affecting their future medical care.

Locations (78)

Instituto de Neumonología Y Dermatología
Capital Federal, Argentina
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aires, Argentina
Fundacion CIDEA
Buenos Aires, Argentina
Fundación Respirar
Buenos Aires, Argentina
The Children's Hospital at Westmead
Westmead, Australia
Veracity Clinical Research
Woolloongabba, Australia
Royal Children's Hospital
Melbourne, Australia
Medizinische Universität Wien
Vienna, Austria
Sozialmedizinisches Zentrum Ost/Donauspital
Vienna, Austria
Medizinische Universität Graz
Graz, Austria
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil
Faculdade de Medicina do ABC
Santo André, Brazil

+66 more sites — see the official record for the full list.

Common questions

What is baricitinib?

Baricitinib is a medicine that's being tested to see if it can help improve eczema symptoms by reducing inflammation in the body.

What is a 'dummy pill' (placebo)?

A dummy pill looks exactly like the study medicine but doesn't contain any active drug. It helps researchers understand if the study medicine is truly effective.

Will my child still use their regular skin creams?

Your child will be asked to use moisturising creams (emollients) daily. Some other eczema treatments might need to be stopped or changed during the study.

How long will the study last for my child?

The exact length of time isn't detailed, but it will involve regular appointments and check-ups over several months to monitor your child's health and eczema.

Can we stop participating at any time?

Yes, you can withdraw your child from the study at any point, for any reason, and this will not affect their future medical care.