We want to advance research for pediatric Alopecia Areata and explore a potential treatment for hair regrowth in children. Together, we can make this happen.
The purpose of the Allegretto study is to research a study medicine, called ritlecitinib, as a potential treatment to promote hair regrowth in children aged 6 to 11 years old who have been diagnosed with Alopecia Areata.
Who may participate
Children from the age of 6 to 11 years old who:
- Have a diagnosis of Alopecia Areata and have experienced hair loss over at least half of their head
- Do not have any other autoimmune disorders or conditions that compromise their immune system
- Have received 2 doses of the chickenpox vaccine, or have had chickenpox
Condition
Alopecia Areata
Age
6 to 11 years old
Sex
Male and female
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if your child qualifies to enroll in the study.
What to expect
Children in the Allegretto study will take part for 7 to 8 months. This will include:
- Screening Period (up to 5 weeks)
- Treatment Period (about 24 weeks)
- Follow-up Period (4 to 5 weeks)
Participants will either receive the study medicine or a placebo for 24 weeks. A placebo looks like the study medicine but does not contain any active ingredients, and is important for confirming the results of the study.
- There is a 2 in 3 chance of receiving the study medicine
- There is a 1 in 3 chance of receiving the placebo
The study treatment will be taken as a capsule every morning for 24 weeks. The capsule should be swallowed whole, but if this is not possible, the capsule can be opened and sprinkled onto food (yogurt, strawberry jam, or applesauce only).
Length of study treatment
7 to 8 months
Number of study visits
8 to 9 visits
About Ritlecitinib
Alopecia Areata is an autoimmune disease that causes hair loss in many people, including children.
In an autoimmune disease, the immune system mistakes cells that belong to the body as being foreign invaders (such as the viruses and bacteria that cause diseases). This can be caused by differences in a person’s genes, something in their environment, or both. In people with Alopecia Areata, the body’s immune system is misdirected to attack its own hair follicles.
The study medicine, ritlecitinib, is designed to block certain signals that cause the immune system to do this.
An Optional Long-Term Extension Study
Children who successfully complete the treatment period of Allegretto may have the option to take part in an open-label extension to this study. All participants in the extension study will receive the study medicine, ritlecitinib.
- Participants who received the study medicine in this trial (either the 30 mg or 50 mg dose) will continue to receive the same dose if they join the extension study.
- Participants who received the placebo in this trial will be randomly assigned to one of the two ritlecitinib doses, with a 1 in 2 chance of receiving the lower dose (30 mg) and a 1 in 2 chance of receiving the higher dose (50 mg).
Participants will receive the study medicine for a certain amount of time, which could be up to 36 months.
The Allegretto Study for children with alopecia areata
Watch a short video to learn more about The Allegretto Study and what to expect.
Frequently asked questions
Most of the study visits will not take up much of your time. One of the study visits (either the Week 4 visit or the Week 8 visit) will last about 4 hours, as your child will have an additional blood test 3 hours after taking the study treatment at the study site.
There are no guaranteed benefits to joining a study. Your child will have regular visits to the study site, and so their health and symptoms will be closely monitored by a team of dedicated healthcare professionals. Participation in this study will help researchers learn more about Alopecia Areata in children and advance a potential treatment option.
Participant safety is the top priority of this study. It is possible your child’s alopecia may improve, worsen, or stay the same. The study doctor will discuss all the possible risks and benefits of participating with you and your child before you choose to take part.
Your child’s participation in this study is completely voluntary. You and your child can choose to stop participating at any time, and for any reason. Choosing not to participate in this study will not affect their medical care.
What happens at each study visit will vary, but may include physical exams, blood and urine tests, a measure of your child’s height and weight, checks of your child’s alopecia, and questionnaires for you and your child to fill in.
