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.
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 years and up
- 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+ years; Adults 18+ 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/your child qualify/qualifies to enroll in the study.
Get started – See if you or your child may be eligible
Answer a 2-minute questionnaire.
A first step as you consider this study is to answer a 2-minute online questionnaire about your (or your child’s) health and medical history. You will also be asked to provide your zip code, which may be used by Pfizer, and our partners working on this study to help improve the study recruitment process. If your answers show the study might be a good fit, you may choose to have your contact information shared with a Pfizer Clinical Trial Contact Center Navigator.
Speak with a study representative.
If you’re interested, a Pfizer Clinical Trial Contact Center Navigator will call you and do a more detailed review of the study and your (or your child’s) medical history to see if you (or your child) may be able to participate and be referred to a study clinic that you select.
Confirm your or your child’s eligibility.
Your answers to these questions will only be linked to you (or your child) if your responses indicate that you (or your child) may be eligible to participate in this study and you choose to share your contact information with the study team. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to individuals. Only the study staff can determine if you (or your child) meets the study’s eligibility criteria and is able to enroll in the study.
What to expect
If this clinical trial is a good fit for you/your child and you decide to take part, you/your child will receive ritlecitinib at a daily dose of 50 mg or 100 mg.
If you/your child are/is initially assigned to receive the 50 mg dose, you/your child may be reassigned to the 100 mg dose after 6 months. Neither you/your child nor the clinical trial doctor will know which dose level has been assigned.
You/your child will take ritlecitinib once daily for up to 48 weeks. 4 weeks after your/your child’s last dose, you/your child will have a follow-up appointment so the team can check on your/your child’s health.
Length of study treatment
14 months
Number of study visits
About 9
About alopecia areata
About alopecia areata
About ritlecitinib
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
What are my/my child chances of receiving the clinical trial medicine?
If this clinical trial is a good fit for you/your child and you decide to take part, you/your child will receive ritlecitinib at a daily dose of 50 mg or 100 mg. There is no placebo in this clinical trial
What is the purpose of the ALLEGRO 100 clinical trial?
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.
What types of tests can I/my child expect during the clinical trial?
Your trial doctor will conduct a physical exam and a series of tests similar to those you/your child may have at a regular doctor’s visit. Your trial doctor will also examine and photograph your/your child’s scalp, eyelashes, and eyebrows to see how much hair loss you/your child have/has and how much you/your child have gained.
What cosmetic treatments are allowed and not allowed during the clinical trial?
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.
