To participate in this study, children must*:
- Be 6 – <18 years of age
- Be clinically diagnosed with atopic dermatitis, also known as eczema, for at least one year
- Have a poor or unsatisfactory response using certain topical medications
You will meet with a study coordinator at a study site located near you. You will learn more about the research study and the benefits and risks of participation.
The study coordinator or study doctor will review the Informed Consent Form with you. You will have the chance to ask any questions about this form, and sign once comfortable and willing to participate in the study. Depending on your child’s age, they may also review and sign the Informed Consent or assent Form. Different procedures and tests will be performed to see if your child qualifies for the clinical study.
Lebrikizumab is a study drug that works to suppress inflammation associated with atopic dermatitis. More than 20 studies have been conducted in adult patients with AD. Early data from these studies indicates the study drug may provide improvement in inflammation associated with atopic dermatitis.
- You (and your child depending on age) will review an Informed Consent Form
- If enrolled, you will be requested to participate in the study for approximately 30 weeks, including screening, treatment, and follow up periods. You will be asked to visit your local study center for approximately 11 scheduled visits.
- During the screening, study drug administration, and follow-up periods your child will be asked to undergo a series of study procedures, including but not limited to physical exams, vital signs, and blood draws.
- Enrolled participants will be asked to receive the study drug once every two weeks or once every four weeks while visiting their local study site.
- Enrolled participants will be asked to use a topical corticosteroid while participating in the Adorable1 Study.
The study centers are located throughout the United States.
Some medications will not be allowed while you are in the study. At the screening visit, the study team will tell you which medications you will need to stop using.
No, there will be no cost to you for the study drug or study procedures.
Clinical Research Studies
Clinical trials, also known as clinical studies or research studies are conducted by doctors and researchers to see if new medications or treatments are safe and effective before being approved for use by the general public. Participation in a clinical trial is completely confidential and will be protected just like any other medical information.
Research studies are used to test new medications for safety, tolerability, and effectiveness before they are approved for use by the public.
You can find out more information about clinical trials by browsing through clinicaltrials.gov. This is an online, government database. It provides information about both federally and privately supported clinical research studies.
All research studies require that doctors and/or researchers give interested participants complete and accurate information about the risks, benefits, and activities of a research study. Interested participants will sign an Informed Consent Form prior to enrolling in the study. These forms show that a participant understands what will happen during the study and that they can leave the study at any time.