NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
Learn more about an open-label clinical trial for children who are 2 to 11 years of age.
Managing your child’s atopic dermatitis (AD), or eczema, 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.
Abrocitinib (CIBINQO™) is an oral medicine approved for the treatment of moderate-to-severe eczema (AD) in people 12 years and older; however, it is not currently available for children under 12.
The JADE-KOALA clinical trial will help us learn if abrocitinib can help improve atopic dermatitis in children who are 2 to 11 years old.
Joining a clinical trial is an important and personal decision. Thank you for considering participation.
This clinical trial may be an option for children who:
This clinical trial is also an option for children currently participating in Pfizer B7451023 or Pfizer B7451030.
There are other requirements for taking part in this clinical trial. The team will explain these to you if you’d like to learn more.
Condition
Atopic dermatitis (eczema)
Age
2-11 years
Sex
Male or Female
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
Your child will take the study medicine by mouth once daily for up to 2 years. If your child’s AD/eczema does not improve within the first 3 months of treatment, their doctor may decide to increase their dose.
If your child did not participate in the B7451023 or B7451030 clinical trial, you will need to help them apply medicated and non-medicated topical therapies to affected areas at least once daily for the first 4 months.
All participants may use permitted topical therapies for AD as needed throughout the clinical trial.
Length of study treatment
Up to 2 years
Number of study visits
15 visits and 6 phone calls
Long-term follow up
28 days
The study medicine being studied in this clinical trial is an oral JAK inhibitor developed by Pfizer called abrocitinib (CIBINQO™). JAK inhibitors may work by blocking the overactive immune response that causes AD.
Abrocitinib is approved for use in adults and pediatric patients 12 years of age and older.
No one’s skin is exactly the same. Many factors, including genetics, race, ethnicity, and gender, can impact how people respond to medicine. That is why it is so important that clinical trials include people of all backgrounds.
The greater the diversity among clinical trial participants, the more we can learn about potential medicines, including how they work for different people.
There is no cost to participate, and you will be compensated for completing clinical trial activities. If you have other children in your home, you may also receive reimbursement for childcare necessary to attend clinical trial visits.
Participating in a clinical trial is your choice. You can choose to have your child leave the clinical trial at any time, for any reason, and your child’s regular medical care will not be affected.
Yes. This is an open-label clinical trial, which means that all participants will receive the study medicine.
