Consider theTRuE-AD5 Clinical Study
About the TRuE-AD5 Study
This clinical study is assessing an investigational cream for moderate AD in children and adolescents 6 to 17 years of age and is seeking volunteers. This medicine is for children and adolescents with moderate AD who have an inadequate response to, or are intolerant to, or contraindicated to topical corticosteroids and topical calcineurin inhibitors.
A child may qualify to participate in the TRuE-AD5 study if they:
- are between 6 and 17 years of age
- have had moderate AD for at least 3 months (if 6-11 years of age) or 2 years (if 12-17 years of age)
- have documented recent history of inadequate response, intolerance, or contraindication in the past 12 months to topical corticosteroids and topical calcineurin inhibitors
If your child meets these criteria, they may be eligible to participate in the TRuE-AD5 study. Please note that this is not a complete list of study requirements. The study coordinator will review the full eligibility criteria with you.
Enter your ZIP code below to find a study site near you and information on how to contact a study coordinator to learn more.
Study Site Locations
Find the TRuE-AD5 study site nearest you. Assistance with study-related travel expenses may be available to eligible participants.
FAQs
More medicines are needed to help treat the symptoms of moderate AD, but they must first be evaluated in clinical studies. This study depends on volunteers to participate to help researchers learn more about the use of an investigational cream in children and adolescents with moderate AD to see if it may help their symptoms. The study doctor and staff may be able to help with any questions or concerns you have about participating.
Research studies like this one are key to developing medicines that may help treat the symptoms of moderate AD.
This study will assess whether an investigational cream is safe and effective compared to a vehicle cream. Researchers want to assess its impact on the severity of moderate AD in children 6 to 17 years of age who have moderate AD and have an inadequate response to, or are intolerant to, or contraindicated to topical corticosteroids and topical calcineurin inhibitors.
The investigational cream is a medicine used to treat moderate AD, also known as eczema. The investigational cream is a topical treatment, meaning it’s applied directly to the skin. When absorbed into the skin, the investigational cream blocks certain enzymes in the body called Janus kinases (JAKs). These enzymes are involved in inflammation, which is a key part of AD. Research studies in adults showed that the investigational cream may help reduce the redness, itching, and other symptoms of AD.
The plan is to enroll at least 240 children in this study, which will consist of:
- A Screening Period of up to about 35 days
- An 8-week Vehicle-Controlled Period (during which time study participants will apply their assigned study cream—either the investigational cream or the vehicle cream—twice daily)
- An Open-Label Extension Period of 2 to 8 weeks (only for participants who do not respond to treatment at the end of the Vehicle-Controlled Period) where participants will apply the investigational cream twice daily
- A Disease-Control Period of up to 44 weeks (where participants will apply study cream proactively twice a week), during which time participants with a disease exacerbation or flare will apply the investigational cream twice daily for 2 to 8 weeks until the flare resolves
- A Safety Follow-up Period consisting of one visit 30 days after the end of treatment to see how participants are doing
Study participation will last up to about 70 weeks.
The study doctor and staff will handle all personal health information in a confidential manner. Personal health information includes both a participant’s study data and original medical records. To protect privacy, participant and/or caregiver names and other personal information will not be identified unless necessary for study purposes. Instead, the participant and/or caregiver will be identified only by a code.
About Clinical Studies
What is a clinical trial?
A clinical trial, also called a clinical research study, is conducted to learn whether an investigational medication is safe and effective for use in people with the medical condition being studied.
Clinical trials/studies are required to follow strict scientific standards to help ensure the safety of the participants while researchers learn more about the investigational medication.
What is an investigational medication?
An investigational medication is a substance that is being tested in clinical studies. An ethics committee has reviewed the clinical study for testing in people, and the investigational medication may or may not be approved by the United States Food and Drug Administration (FDA) for treatment for the condition being studied.
The information about the investigational cream and the TRuE-AD5 clinical trial is sourced from the provided Incyte Corporation Clinical Study Protocol document. It is recommended that you consult with a healthcare professional for further clarification and guidance.