We want to continue advancing research for pediatric Alopecia Areata and exploring a potential treatment for hair regrowth in children. Together, we can make this happen.

The purpose of the Allegretto-LTE study is to learn how well the study medicine ritlecitinib works to prevent hair loss and promote hair regrowth in children with Alopecia Areata when taken for a longer amount of time.

Who may participate

 

Children who: 

  • Have previously completed one of Pfizer’s pediatric studies for Alopecia Areata (the B7981027 Allegretto study or the B7981031 trial)
  • 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

6-15

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. 

View more eligibility criteria

Additional eligibility criteria

  • Participants with Alopecia Areata, including Alopecia Totalis (total hair loss on the head) and Alopecia Universalis (total loss of all body hair), who completed either the B7981027 Allegretto study or B7981031 study.
  • Have sudden hearing loss (some exceptions apply, such as cleared wax build up or resolved infections)
  • Experienced any serious side effects when taking the study treatment during their previous study
  • Have any kidney or liver health issues
  • Have had major surgery in the last month
  • Have any serious infections, which includes tuberculosis, HIV, shingles, hepatitis B, or hepatitis C
  • Vaccination with live attenuated replication-competent vaccine within 6 weeks of first dose of study intervention

What to expect

Children in the Allegretto-LTE study will take part for about 3 years. This will include: 

  • Screening Period
  • Treatment Period 

Each child will receive the study medicine – there is no placebo-only group in this study. All participants will take two capsules – one study medicine capsule and one placebo capsule – each day as their study treatment.

Participants who received the study medicine in the Allegretto study will receive the same dose of the study medicine in the Allegretto-LTE study. All other participants will be randomly assigned, like pulling names out of a hat, to receive one of the two doses of study medicine. 

The study treatment (study medicine and placebo) will be taken as two capsules every morning for about 3 years. The capsules should be swallowed whole, but if this is not possible, the capsules can be opened and sprinkled onto food (yogurt, strawberry jam, or applesauce only).

Length of study treatment

3 years

Number of study visits

17 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.

About Ritlecitinib

niña sonriendo a la cámara: Estudio clínico de Pfizer
niña sonriendo a la cámara: Estudio clínico de Pfizer

The Allegretto-LTE Study for children with alopecia areata

Watch a short video to learn more about The Allegretto-LTE Study and what to expect. 

Frequently asked questions

What are the possible benefits of participating?

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.

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What are the possible risks of participating?

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.

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What if we change our minds about participating?

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.

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What will happen at study visits?

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.

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