The ALLEGRO 100 clinical trial will determine if taking ritlecitinib at a dose of 100mg per day is safe, and if it can help more hair grow back.
LITFULO™ (ritlecitinib) is a prescription pill that is approved by the United States Food and Drug Administration (FDA) to treat severe alopecia areata in adults and teenagers 12 years and up to a 50mg dose per day.
Who may participate
This clinical trial may be an option for people who:
- Are 12 to 17 years old
- Are generally healthy with no major changes in recent medical history
- Have been diagnosed with alopecia areata and do not have hair loss caused by any other conditions
- Have lost at least 50% of the hair on their scalp
- Are in a current hair loss episode that has lasted 10 years or less
Condition
Alopecia areata
Age
Adolescents 12 to 17 years old
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 your child qualifies to enroll in the study.
What to expect
If this clinical trial is a good fit and your teen decides to take part, they will receive ritlecitinib at a daily dose of 100 mg.
Your teen will take ritlecitinib once daily for up to 48 weeks. 4 weeks after their last dose, your teen will have a follow-up appointment so the team can check on their health.
Length of study treatment
14 months
Number of study visits
About 8
About alopecia areata
Alopecia areata is an autoimmune (immune system) disorder that causes hair loss. People with alopecia areata usually lose patches of hair on their scalp, but in some cases, may lose all of the hair on their head or body. While there is no cure for alopecia areata, there are treatments available to help regrow hair and prevent hair loss. Pfizer continues to advance treatment options for alopecia areata every day.
About ritlecitinib
Ritlecitinib (LITFULO™) is a prescription pill that works by preventing immune system cells from mistakenly attacking hair follicles. Ritlecitinib has been approved by the United States Food and Drug Administration (FDA) since 2023 for individuals 12 years and up with severe alopecia areata at a daily dose of 50 mg.
Frequently asked questions
If this clinical trial is a good fit and your teen decides to take part, they will receive ritlecitinib at a daily dose of 100 mg.
The ALLEGRO 100 clinical trial will determine if taking ritlecitinib at a dose of 100mg per day is safe, and if it can help more hair grow back.
Your trial doctor will conduct a physical exam and a series of tests similar to those your child may have at a regular doctor’s visit. Your trial doctor will also examine and photograph your child’s scalp, eyelashes, and eyebrows to see how much hair loss your child has and how much your child has gained.
Participants must not shave their scalp, eyebrows, or eyelashes during the clinical trial. Participants are allowed to keep their hair short and at an appropriate length as discussed with the trial doctor to monitor for hair regrowth. Additionally, hair transplants and scalp, eyebrow, and eyelash tattooing or microblading is not allowed during the clinical trial.
Wigs and hair extensions may be used during the trial but must be removed at trial visits for scalp assessments. Hair dye and color is also permitted but is discouraged within 7 days prior to a visit.
Mascara and eyelash extensions are also allowed during the clinical trial, but should be removed before visits. Eyelash extensions applied with adhesive glue are discouraged
