A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
This study is investigating a medicine called abrocitinib for children aged 2 and up who have moderate to severe eczema (atopic dermatitis). It's a long-term study, lasting up to two years, to see how safe and well the medicine works. Some children in the study will have taken abrocitinib in previous trials, and others will be trying it for the first time. The medicine will be given as a liquid, and some children might also use other skin treatments. The main goal is to understand the long-term effects of abrocitinib in managing eczema in children. It's an important step in finding better ways to help children with this condition.
At a glance
What is this study about?
This study is focused on a medicine called abrocitinib, which is being tested for children aged 2 and older who have moderate to severe eczema, also known as atopic dermatitis. Eczema is a common skin condition that causes dryness, itching, and rashes. For many children, eczema can be difficult to manage, even with regular creams and ointments.
The main aim of this study is to look at the long-term effects of abrocitinib. This means researchers want to understand how safe the medicine is and how well it works over a longer period, up to two years. They are particularly interested in seeing if it can help improve children's eczema more effectively than current treatments. The medicine will be given as a liquid, and some children might continue to use other skin treatments alongside it.
There are two groups of children taking part in this study. One group includes children who have participated in earlier studies for abrocitinib. The other group, called the 'de novo' group, will be children aged 6 to under 12 who have not tried abrocitinib before. By studying both groups, researchers can get a full picture of how the medicine works for different children with eczema.
Key takeaways
- Tests a liquid medicine called abrocitinib for children's eczema.
- A long-term study (up to 2 years) for children aged 2 and older.
- Includes children who have previously used abrocitinib and those who haven't.
- Aims to understand the medicine's long-term safety and effectiveness.
- Participants will have regular check-ups with the study team.
Who may be eligible?
The study is looking for children with moderate to severe eczema. If your child has already been in an abrocitinib study, they can join if they've finished the treatment part of that previous study and are between 2 and under 12 years old. Girls and young women of child-bearing potential in this group must not be pregnant or breastfeeding, and need to use effective birth control during the study and for 28 days afterwards. Boys in this group do not need to use birth control.
If your child hasn't been in an abrocitinib study before, they can join if they are between 6 and under 12 years old. They must have a clear diagnosis of eczema for at least six months and have moderate to severe eczema that covers a certain amount of their body, is very itchy, and hasn't responded well to usual skin creams or ointments. They should also weigh at least 15 kg (about 2 stone 5 pounds).
Children generally cannot join if they have other serious health problems, certain mental health worries, or if the study doctor believes it wouldn't be safe for them to take part. This ensures the safety of all children in the study.
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 2 and under 12 years old?
- Does your child have moderate to severe eczema?
- Has your child's eczema not improved enough with regular creams/ointments?
- Does your child weigh at least 15 kg (if joining for the first time)?
- Is your child free from other serious ongoing health issues?
What does participation involve?
If your child takes part in this study, they will receive the study medicine, abrocitinib, as a liquid. The study will last for up to two years, or until the medicine becomes widely available, whichever comes first. Throughout this time, your child will have regular visits to the study clinic. During these visits, the medical team will check how your child's eczema is responding to the medicine and monitor their general health. This will involve physical examinations, taking measurements, asking about symptoms, and possibly blood tests or other assessments. All participants will take the study medicine. The study involves children from all over the world, with up to 500 children taking part in total.
Potential risks and benefits
Locations (31)
- Cahaba Dermatology & Skin Health CenterVerified postcodeBirmingham, United States· Recruiting
- Arkansas Research TrialsVerified postcodeNorth Little Rock, United States· Recruiting
- Investigational Drug Service - Rady Childrens Hospital-San DiegoVerified postcodeSan Diego, United States· Not yet recruiting
- University of California, San Diego/ Rady Children's Hospital - San DiegoVerified postcodeSan Diego, United States· Not yet recruiting
- Solutions Through Advanced ResearchVerified postcodeJacksonville, United States· Recruiting
- Dawes Fretzin Clinical Research Group, LLCVerified postcodeIndianapolis, United States· Not yet recruiting
- Tribe Clinical Research, LLCVerified postcodeGreenville, United States· Recruiting
- Hunan Children's HospitalVerified postcodeChangsha, China· Not yet recruiting
- Dermatology Hospital of Jiangxi ProvinceVerified postcodeNanchang, China· Not yet recruiting
- Hangzhou Third People's HospitalVerified postcodeHangzhou, China· Not yet recruiting
- Xinhua Hospital Affiliated to Shanghai JiaoTong University School of MedicineVerified postcodeShanghai, China· Recruiting
- Universitätsklinikum MünsterVerified postcodeMünster, Germany· Not yet recruiting
Common questions
What is abrocitinib?
Abrocitinib is a medicine being studied to treat moderate to severe eczema (atopic dermatitis) in children. It comes as a liquid.
How long will the study last for my child?
Your child's participation in the study will last for up to two years.
Will my child still use their regular eczema creams?
Yes, some children in the study might continue to use their usual skin creams or ointments for eczema alongside the study medicine.
What happens if my child doesn't want to continue the study?
You and your child can choose to leave the study at any time, for any reason, without it affecting their regular medical care.
Where is this study taking place?
This study is taking place at various locations around the world, enrolling children from different countries.
How to find out more
Pfizer CT.gov Call Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.