Alopecia areata (AA) causes the immune system to attack hair follicles, making your hair fall out, often appearing patchy. There aren’t approved treatments for moderate AA, so that is why Pfizer is studying a potential treatment option.
We are evaluating an oral study medicine, taken once a day, to see if it may help hair grow back in moderate alopecia areata (AA). The study medicine (ritlecitinib 50 mg once a day) is already approved for treating severe AA. If you decide to participate in this clinical trial, you’ll receive care from a team of dedicated specialists, and you’ll help us continue to make progress in AA research.
Who may participate
This clinical trial may be an option if you:
- Are aged 12 or older
- Have been diagnosed with moderate AA* and do not have hair loss caused by any other condition
- Have been experiencing hair loss for longer than 6 months but less than 10 years
- Are generally healthy with no major changes in recent medical history
There will be other requirements that the study team will talk about with you. *Your doctor or the study team will determine if your AA is considered moderate.
Condition
Moderate alopecia areata (AA)
Age
Adolescents 12 to 17 years old/Adults 18 years or older
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 qualify to enroll in the study.
What to expect
If this clinical trial is a good fit for you and you decide to take part, you will be assigned by chance (like pulling a number out of a hat) to receive the study medicine (ritlecitinib 50 mg) or placebo.
- 2 out of 3 people will receive the study medicine
- 1 out of 3 people will receive the placebo
The placebo looks like the study medicine but does not contain any active ingredients. You won’t know which treatment you are receiving.
You will take ritlecitinib or placebo once a day for 24 weeks (about 6 months). After 24 weeks, your assigned treatment may stay the same or change to ritlecitinib 50 mg or 100 mg once a day based on how your alopecia areata is responding. You will receive the newly assigned treatment for another 6 months.
About 4 weeks after your last dose, you will have a follow-up visit to check on your health.
Length of study treatment
About 12 months
Number of study visits
About 11 visits
Follow up
1 visit
About the study medicine
The study medicine ritlecitinib (LITFULO®) is a prescription pill approved (50 mg once a day only) in multiple countries for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older. It is not currently approved for the treatment of moderate alopecia areata.
About alopecia areata
Alopecia areata (AA) causes the body’s immune system to attack healthy hair follicles, making hair fall out. It most commonly appears as patches of hair loss that are usually on the head and face.
AA affects everyone differently. For some, it happens as a one-time hair loss and the hair grows back on its own. For others, it can come and go over a lifetime. There is no cure, and that is why Pfizer is continuing to study a potential treatment option.
It’s important that everyone has treatment options that work for them, regardless of their background. The greater the representation among clinical trial participants, the more we can learn about potential treatments and how they work for different people.
Frequently asked questions
No, all clinical trial-related care and the study medicine will be provided at no cost. You will be paid back for your transportation costs related to the clinical trial.
Your study doctor will conduct a physical exam and a series of tests similar to those you may have at a regular doctor’s visit. The study doctor will also examine and photograph your scalp, eyelashes, eyebrows, beard, and nails to see how much hair loss you have and how much hair you may have gained.
Photos will be taken to track areas on the body affected by alopecia areata, evaluate changes in hair loss or growth over time, and determine how you are responding to the study treatment.
Your photos will only be used for approved study-related purposes. They will not be shared with other study participants, and they will not be published without your express written permission. When the photos are used in publication, facial photos will be cropped and/or masked for de-identification whenever possible.
If you have more questions regarding medical photography, please contact the study team.
