Atopic dermatitis (AD), or eczema, is common in children. It causes patches of itchy, dry, and inflamed skin that can make it difficult to sleep or focus in school. Children with AD may also struggle with feelings of embarrassment and low self-esteem.

Managing AD can be challenging. Topical treatments are not always effective, and other medications may cause unwanted side effects or be difficult for children to tolerate. That is why we are researching another potential option.

This clinical trial will help us learn if taking an oral medicine in combination with approved topical therapies can help to improve atopic dermatitis in children who are 6 to 11 years old.

Who Can Take Part?

This clinical trial may be an option for children who:

• Are 6 to 11 years of age
• Weigh at least 15 kg (33 lbs.)
• Were diagnosed with AD at least 1 year ago
• Currently have moderate-to-severe AD
• Have not had adequate results from topical medications for AD

There are other requirements that the team will discuss with you.

Clinical Trial Duration

Your child will be enrolled for about 5 months.

Clinical Trial Visits

You will have about 7 in-person visits and 3 phone calls.

What to Expect

All participants will have a 2 in 3 chance of receiving the study medicine. This means that for every 3 participants, 2 will receive the study medicine, and 1 will receive a placebo. The placebo looks just like the study medicine but does not contain any active ingredients. You will not know what your child has been assigned to receive.

Your child will take the study medicine or placebo by mouth once daily for 4 months. During this time, you will also need to help your child apply topical therapies to affected areas at least once daily.

After 4 months, your child will be able to receive the study medicine in an open-label extension clinical trial (no chance of placebo).

What Else to Know

• Safety is always the top priority of any clinical trial. Your child’s health will be carefully monitored by the clinical trial team.
• There is no cost to participate. [You will also be compensated for completing clinical trial activities.]

Participation is your choice. You can choose to have your child leave the clinical trial at any time, for any reason.