NCT05650333
Introducing a clinical trial for children with severe alopecia areata
Alopecia areata is a form of hair loss that occurs in children and adults, affecting as many as 6 to 7 million individuals in the US and 147 million worldwide. Alopecia areata can cause high levels of anxiety and depression. However, so far there is no definitive cure for alopecia areata.
The B7981031 trial will help us learn if an investigational or study medicine can be used in children for the treatment of alopecia areata.
Who may participate
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.
What to expect
You and your child will be contacted by phone 35-42 days after you take the last dose of study medicine.
Some studies require the study team to stay in contact with the participant for a period of time after the participant completes the main part of the study. This long-term follow up is to collect additional information on the study medicine over time.
What does participation involve?
What does participation involve?
Your child will be in this trial for approximately two months, including a 28-day screening period, 7-day treatment period, and a 35-42 day follow-up period. They will be asked to take one capsule of the study medicine (dissolved in water) each day, in the morning, for one week.
They will have three office visits, one at screening, one at the beginning of treatment and one at the end of treatment or early end of the study.
Your child’s study doctor or the study nurse will contact you and your child by phone at least four times between your child’s first and last dose of the study medicine and, again, 35-42 days after the last dose.
Frequently asked questions
How is the study medication taken?
Your child will be asked to take one capsule of the study medicine each day, in the morning, for one week. You will receive all 7 capsules on the first day in a bottle. Each capsule must be dissolved in water before your child takes it. You may use tap water or spring water (but not carbonated water). Do not add sugar or any sweetener to the water. Once dissolved, the study medicine should be taken immediately. Never keep the dissolved study medicine to take later in the day, not even in the fridge.
How often do you assess my child’s blood sample?
Blood samples from your child will be required at the first and last visit. Your child will have one blood test at the screening visit. Additionally, on the 7th day, your child will have 5 blood tests, once before the last dose of the study medicine, then at 30 minutes, one hour, three hours and 8 hours after the last dose of the study medicine.
How long do study visits last?
It won't take you and your child much time on the first and second visits. On the third visit, when your child will receive last dose of study medicine, you may have to spend up to 9 hours at the site, until all the blood samples are collected.
Do we have access to the study medicine outside of this study?
The study medicine is still being researched, and your child can only have it during their participation in the study, not after they have finished taking part. If your child completes this study, they might be eligible to enroll in another long-term study that will provide treatment with the study medicine for up to 3 years.
Will I get reimbursed for study-related cost?
You may be reimbursed for any reasonable expenses that you may have as a result of taking part in this study. This may include parking, meals, or other travel-related expenses.
